https://cnajini.tistory.com/ 의약품 품질관리/품질보증 총괄 담당자로 종사하고 있습니다. 의약품 품질관리/품질보증 종사자로서 정보와 기술자료를 정리하고 활용하고자 합니다. 정보와 기술자료 라는 것이 이론적으로 심도있는 자료의 의미가 아니라 현업에서 사용되고 있는 가장 기초적인 자료를 뜻합니다. 의약품 품질관리/품질보증 종사자 및 의약품을 사용하는 이들에게 조금이나마 도움이 되었으면 합니다. ko Sun, 5 Apr 2026 07:23:11 +0900 TISTORY 100 빛별구 https://tistory1.daumcdn.net/tistory/7561450/attach/a18808b11d8d403db98f5b956b5aaea9 https://cnajini.tistory.com https://cnajini.tistory.com/591 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">호흡기세포융합바이러스 백신 평가 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 호흡기세포융합바이러스 백신 평가 가이드라인에 대하여 알기&nbsp;쉽게&nbsp;설명하거나&nbsp;식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">호흡기세포융합바이러스 백신 평가 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="514" data-origin-height="714"><span data-url="https://blog.kakaocdn.net/dn/qmXo6/dJMcaco3IJO/5S4GrfEBE97Ooh9Y7TrL60/img.png" data-phocus="https://blog.kakaocdn.net/dn/qmXo6/dJMcaco3IJO/5S4GrfEBE97Ooh9Y7TrL60/img.png"><img src="https://blog.kakaocdn.net/dn/qmXo6/dJMcaco3IJO/5S4GrfEBE97Ooh9Y7TrL60/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FqmXo6%2FdJMcaco3IJO%2F5S4GrfEBE97Ooh9Y7TrL60%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="514" height="714" data-origin-width="514" data-origin-height="714"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="508" data-origin-height="235"><span data-url="https://blog.kakaocdn.net/dn/DNfRv/dJMb99TomVa/K0d7bSF8S6UYK8C0DXWgRK/img.png" data-phocus="https://blog.kakaocdn.net/dn/DNfRv/dJMb99TomVa/K0d7bSF8S6UYK8C0DXWgRK/img.png"><img src="https://blog.kakaocdn.net/dn/DNfRv/dJMb99TomVa/K0d7bSF8S6UYK8C0DXWgRK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FDNfRv%2FdJMb99TomVa%2FK0d7bSF8S6UYK8C0DXWgRK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="508" height="235" data-origin-width="508" data-origin-height="235"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="512" data-origin-height="697"><span data-url="https://blog.kakaocdn.net/dn/LhwrZ/dJMcahKGi01/lqHAsgllKXNd9WacalufYK/img.png" data-phocus="https://blog.kakaocdn.net/dn/LhwrZ/dJMcahKGi01/lqHAsgllKXNd9WacalufYK/img.png"><img src="https://blog.kakaocdn.net/dn/LhwrZ/dJMcahKGi01/lqHAsgllKXNd9WacalufYK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FLhwrZ%2FdJMcahKGi01%2FlqHAsgllKXNd9WacalufYK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="512" height="697" data-origin-width="512" data-origin-height="697"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">호흡기세포융합바이러스 백신 </span>평가</span><span>&nbsp;</span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/clODB4/dJMcacWSnka/PT64Rmsb9KSg4vaOu6q7d1/%ED%98%B8%ED%9D%A1%EA%B8%B0%EC%84%B8%ED%8F%AC%EC%9C%B5%ED%95%A9%EB%B0%94%EC%9D%B4%EB%9F%AC%EC%8A%A4%2B%EB%B0%B1%EC%8B%A0%2B%ED%8F%89%EA%B0%80%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">호흡기세포융합바이러스+백신+평가+가이드라인(민원인+안내서).pdf</span></div> <div class="size">0.56MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15841&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 rsv백신 면역원성 백신개발 백신평가 생물의약품 식품의약품안전처 안전성평가 의약품가이드라인 임상시험 호흡기세포융합바이러스 빛별구 https://cnajini.tistory.com/591 https://cnajini.tistory.com/591#entry591comment Fri, 3 Apr 2026 14:28:33 +0900 https://cnajini.tistory.com/590 <p data-ke-size="size16"><span style="background-color: #ffffff; letter-spacing: 0px;">안녕하세요. 별구 입니다.​</span></p> <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혈장분획제제 품질평가 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 혈장분획제제 품질평가에 대하여 알기 쉽게 설명하거나 식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혈장분획제제 품질평가 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="531" data-origin-height="674"><span data-url="https://blog.kakaocdn.net/dn/Z2vR8/dJMcadOYkmW/bwmFm05t4ZAoKKE5Pn9gWk/img.png" data-phocus="https://blog.kakaocdn.net/dn/Z2vR8/dJMcadOYkmW/bwmFm05t4ZAoKKE5Pn9gWk/img.png"><img src="https://blog.kakaocdn.net/dn/Z2vR8/dJMcadOYkmW/bwmFm05t4ZAoKKE5Pn9gWk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FZ2vR8%2FdJMcadOYkmW%2FbwmFm05t4ZAoKKE5Pn9gWk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="531" height="674" data-origin-width="531" data-origin-height="674"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="483" data-origin-height="337"><span data-url="https://blog.kakaocdn.net/dn/JF4PL/dJMcaiv0qu3/uyhQa0kezQkjpMOczK5Zh0/img.png" data-phocus="https://blog.kakaocdn.net/dn/JF4PL/dJMcaiv0qu3/uyhQa0kezQkjpMOczK5Zh0/img.png"><img src="https://blog.kakaocdn.net/dn/JF4PL/dJMcaiv0qu3/uyhQa0kezQkjpMOczK5Zh0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FJF4PL%2FdJMcaiv0qu3%2FuyhQa0kezQkjpMOczK5Zh0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="483" height="337" data-origin-width="483" data-origin-height="337"/></span></figure> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="513" data-origin-height="677"><span data-url="https://blog.kakaocdn.net/dn/8fV4X/dJMcaiQiw7V/pk0GgjYAKP4RK4KH8FhaEk/img.png" data-phocus="https://blog.kakaocdn.net/dn/8fV4X/dJMcaiQiw7V/pk0GgjYAKP4RK4KH8FhaEk/img.png"><img src="https://blog.kakaocdn.net/dn/8fV4X/dJMcaiQiw7V/pk0GgjYAKP4RK4KH8FhaEk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F8fV4X%2FdJMcaiQiw7V%2Fpk0GgjYAKP4RK4KH8FhaEk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="513" height="677" data-origin-width="513" data-origin-height="677"/></span></figure> </div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="513" data-origin-height="555"><span data-url="https://blog.kakaocdn.net/dn/cKbwSD/dJMcaiQiw9p/PjFtRhtR136RJevuKoF36k/img.png" data-phocus="https://blog.kakaocdn.net/dn/cKbwSD/dJMcaiQiw9p/PjFtRhtR136RJevuKoF36k/img.png"><img src="https://blog.kakaocdn.net/dn/cKbwSD/dJMcaiQiw9p/PjFtRhtR136RJevuKoF36k/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcKbwSD%2FdJMcaiQiw9p%2FPjFtRhtR136RJevuKoF36k%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="513" height="555" data-origin-width="513" data-origin-height="555"/></span></figure> </div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혈장분획제제 품질평가</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/MkPgE/dJMcafsxgzC/RVIHc0vFLVPRRf3rvC9cVK/%ED%98%88%EC%9E%A5%EB%B6%84%ED%9A%8D%EC%A0%9C%EC%A0%9C%2B%ED%92%88%EC%A7%88%ED%8F%89%EA%B0%80%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">혈장분획제제+품질평가+가이드라인(민원인+안내서).pdf</span></div> <div class="size">0.41MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15840&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1775017413693" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="혈장분획제제 품질평가 가이드라인 이전 이력 확인학기 ▼ 첨부파일 첨부파일 전체 다운로드 --&gt; 혈장분획제제 품질평가 가이드라인(민원인 안내서).pdf 다운받기 미리보기 첨부파일 보기 첨부" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15840&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15840&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15840&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15840&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">혈장분획제제 품질평가 가이드라인 이전 이력 확인학기 ▼ 첨부파일 첨부파일 전체 다운로드 --&gt; 혈장분획제제 품질평가 가이드라인(민원인 안내서).pdf 다운받기 미리보기 첨부파일 보기 첨부</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> </div> 품질보증(QA)/안내서_지침서 등 GMP 바이오의약품 생물의약품 식품의약품안전처 의약품가이드라인 의약품규제 의약품품질관리 품질평가 혈액제제 혈장분획제제 빛별구 https://cnajini.tistory.com/590 https://cnajini.tistory.com/590#entry590comment Thu, 2 Apr 2026 14:24:44 +0900 https://cnajini.tistory.com/589 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">정맥주사용 B형 간염 사람면역글로불린제제의 안전성&middot;유효성 평가 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 정맥주사용 B형 간염 사람면역글로불린 제제의 안전성‧유효성 평가에 대하여 알기 쉽게 설명하거나 식품의약품안전처의 입장을 기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">정맥주사용 B형 간염 사람면역글로불린제제의 안전성&middot;유효성 평가 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="493" data-origin-height="667"><span data-url="https://blog.kakaocdn.net/dn/bojy3U/dJMcab4KdOp/W6dXTnxs4FCO7uzsPKNCU0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bojy3U/dJMcab4KdOp/W6dXTnxs4FCO7uzsPKNCU0/img.png"><img src="https://blog.kakaocdn.net/dn/bojy3U/dJMcab4KdOp/W6dXTnxs4FCO7uzsPKNCU0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbojy3U%2FdJMcab4KdOp%2FW6dXTnxs4FCO7uzsPKNCU0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="493" height="667" data-origin-width="493" data-origin-height="667"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="494" data-origin-height="293"><span data-url="https://blog.kakaocdn.net/dn/pjSJX/dJMcab4KdQf/nL3RcQ6vkvcpnhT2Pdk9M0/img.png" data-phocus="https://blog.kakaocdn.net/dn/pjSJX/dJMcab4KdQf/nL3RcQ6vkvcpnhT2Pdk9M0/img.png"><img src="https://blog.kakaocdn.net/dn/pjSJX/dJMcab4KdQf/nL3RcQ6vkvcpnhT2Pdk9M0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FpjSJX%2FdJMcab4KdQf%2FnL3RcQ6vkvcpnhT2Pdk9M0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="494" height="293" data-origin-width="494" data-origin-height="293"/></span></figure> </p> <div style="color: #333333; text-align: center;">&nbsp;</div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="507" data-origin-height="652"><span data-url="https://blog.kakaocdn.net/dn/O8T4Q/dJMcaduFovD/cKs1dvCl9fqfWlkwy6hfg1/img.png" data-phocus="https://blog.kakaocdn.net/dn/O8T4Q/dJMcaduFovD/cKs1dvCl9fqfWlkwy6hfg1/img.png"><img src="https://blog.kakaocdn.net/dn/O8T4Q/dJMcaduFovD/cKs1dvCl9fqfWlkwy6hfg1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FO8T4Q%2FdJMcaduFovD%2FcKs1dvCl9fqfWlkwy6hfg1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="507" height="652" data-origin-width="507" data-origin-height="652"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">정맥주사용 B형 간염 사람면역글로불린제제의 안전성&middot;유효성 평가</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/EtDIO/dJMcaco3HrF/GkyG71Orzk89GaZLVppw9K/%EC%A0%95%EB%A7%A5%EC%A3%BC%EC%82%AC%EC%9A%A9%2BB%ED%98%95%EA%B0%84%EC%97%BC%2B%EC%82%AC%EB%9E%8C%EB%A9%B4%EC%97%AD%EA%B8%80%EB%A1%9C%EB%B6%88%EB%A6%B0%EC%A0%9C%EC%A0%9C%EC%9D%98%2B%EC%95%88%EC%A0%84%EC%84%B1%EC%9C%A0%ED%9A%A8%EC%84%B1%2B%ED%8F%89%EA%B0%80%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">정맥주사용+B형간염+사람면역글로불린제제의+안전성유효성+평가+가이드라인(민원인+안내서).pdf</span></div> <div class="size">0.30MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15839&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1775017132374" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="정맥주사용 B형 간염 사람면역글로불린제제의 안전성&middot;유효성 평가 가이드라인 등록번호 안내서-0256-02 분야 고시일 2026-03-31 등록일 2026-03-31 조회수 73 이전 이력 확인학기 ▼ 첨부파일 첨부파일 " data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15839&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15839&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15839&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15839&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">정맥주사용 B형 간염 사람면역글로불린제제의 안전성&middot;유효성 평가 가이드라인 등록번호 안내서-0256-02 분야 고시일 2026-03-31 등록일 2026-03-31 조회수 73 이전 이력 확인학기 ▼ 첨부파일 첨부파일</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 B형간염 면역글로불린 생물의약품 식품의약품안전처 안전성평가 의약품가이드라인 의약품규제 정맥주사제 빛별구 https://cnajini.tistory.com/589 https://cnajini.tistory.com/589#entry589comment Wed, 1 Apr 2026 13:20:20 +0900 https://cnajini.tistory.com/588 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 국제표준품 확보 및 관리 절차</span> </span>자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 생물의약품 국제표준품 확보 및 관리 절차의 세부 지침을 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 국제표준품 확보 및 관리 절차</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="522" data-origin-height="711"><span data-url="https://blog.kakaocdn.net/dn/uj2qG/dJMcaaktjLJ/OD8KnCvEs9U3wpYRzigHFK/img.png" data-phocus="https://blog.kakaocdn.net/dn/uj2qG/dJMcaaktjLJ/OD8KnCvEs9U3wpYRzigHFK/img.png"><img src="https://blog.kakaocdn.net/dn/uj2qG/dJMcaaktjLJ/OD8KnCvEs9U3wpYRzigHFK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fuj2qG%2FdJMcaaktjLJ%2FOD8KnCvEs9U3wpYRzigHFK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="522" height="711" data-origin-width="522" data-origin-height="711"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="493" data-origin-height="294"><span data-url="https://blog.kakaocdn.net/dn/PkOjX/dJMcafF5InH/HhM9NgkQ9PVyJQ1MrqojJk/img.png" data-phocus="https://blog.kakaocdn.net/dn/PkOjX/dJMcafF5InH/HhM9NgkQ9PVyJQ1MrqojJk/img.png"><img src="https://blog.kakaocdn.net/dn/PkOjX/dJMcafF5InH/HhM9NgkQ9PVyJQ1MrqojJk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FPkOjX%2FdJMcafF5InH%2FHhM9NgkQ9PVyJQ1MrqojJk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="493" height="294" data-origin-width="493" data-origin-height="294"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="484" data-origin-height="699"><span data-url="https://blog.kakaocdn.net/dn/pBF0C/dJMcagdVZTg/N0ghknaDP6sX8v0VCWo2BK/img.png" data-phocus="https://blog.kakaocdn.net/dn/pBF0C/dJMcagdVZTg/N0ghknaDP6sX8v0VCWo2BK/img.png"><img src="https://blog.kakaocdn.net/dn/pBF0C/dJMcagdVZTg/N0ghknaDP6sX8v0VCWo2BK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FpBF0C%2FdJMcagdVZTg%2FN0ghknaDP6sX8v0VCWo2BK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="484" height="699" data-origin-width="484" data-origin-height="699"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 국제표준품 확보 및 관리</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/F2GXf/dJMcaiW37fp/uEu44ZCLiKQBrjiDBz3ML1/%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%EC%9D%98%2B%EA%B5%AD%EC%A0%9C%ED%91%9C%EC%A4%80%ED%92%88%2B%ED%99%95%EB%B3%B4%2B%EB%B0%8F%2B%EA%B4%80%EB%A6%AC%2B%EC%A0%88%EC%B0%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">생물의약품의+국제표준품+확보+및+관리+절차(공무원지침서).pdf</span></div> <div class="size">0.98MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15238&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 GMP 국제표준품 바이오의약품 생물의약품 시험표준 식품의약품안전처 의약품규제 의약품품질관리 표준품관리 품질시험 빛별구 https://cnajini.tistory.com/588 https://cnajini.tistory.com/588#entry588comment Wed, 1 Apr 2026 13:14:43 +0900 https://cnajini.tistory.com/587 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>의약품 연속공정 예시모델&middot;기초기술 개발 결과 공개 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용으로 마련되었습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1342" data-origin-height="440"><span data-url="https://blog.kakaocdn.net/dn/pEz3s/dJMcahYarJH/7TquQzEQLAWaMbn65O8sWk/img.png" data-phocus="https://blog.kakaocdn.net/dn/pEz3s/dJMcahYarJH/7TquQzEQLAWaMbn65O8sWk/img.png"><img src="https://blog.kakaocdn.net/dn/pEz3s/dJMcahYarJH/7TquQzEQLAWaMbn65O8sWk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FpEz3s%2FdJMcahYarJH%2F7TquQzEQLAWaMbn65O8sWk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1342" height="440" data-origin-width="1342" data-origin-height="440"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>의약품 연속공정 예시모델&middot;기초기술 개발 결과 공개 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 23일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​붙임_1._2025년+의약품+연속공정+예시모델(K+정제+1-직접타정)</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="550" data-origin-height="785"><span data-url="https://blog.kakaocdn.net/dn/b3dZGZ/dJMcaiQgLzh/knIggZaDZi7m1dU5MrllPk/img.png" data-phocus="https://blog.kakaocdn.net/dn/b3dZGZ/dJMcaiQgLzh/knIggZaDZi7m1dU5MrllPk/img.png"><img src="https://blog.kakaocdn.net/dn/b3dZGZ/dJMcaiQgLzh/knIggZaDZi7m1dU5MrllPk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fb3dZGZ%2FdJMcaiQgLzh%2FknIggZaDZi7m1dU5MrllPk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="550" height="785" data-origin-width="550" data-origin-height="785"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">붙임_2._2025년+의약품+연속공정+예시모델(K+정제+2-습식과립)</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="783"><span data-url="https://blog.kakaocdn.net/dn/llGZD/dJMcaf0kI39/ykKyeruIi8egMyKlHV8j6K/img.png" data-phocus="https://blog.kakaocdn.net/dn/llGZD/dJMcaf0kI39/ykKyeruIi8egMyKlHV8j6K/img.png"><img src="https://blog.kakaocdn.net/dn/llGZD/dJMcaf0kI39/ykKyeruIi8egMyKlHV8j6K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FllGZD%2FdJMcaf0kI39%2FykKyeruIi8egMyKlHV8j6K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="783" data-origin-width="535" data-origin-height="783"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">붙임_3._2025년+의약품+연속공정+예시모델+결과+CTD+보고서+(K+정제+1-직접타정)</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="591" data-origin-height="731"><span data-url="https://blog.kakaocdn.net/dn/1lN2e/dJMcac3BAxn/Z96tHZBaCXjQ9giGKWwGgk/img.png" data-phocus="https://blog.kakaocdn.net/dn/1lN2e/dJMcac3BAxn/Z96tHZBaCXjQ9giGKWwGgk/img.png"><img src="https://blog.kakaocdn.net/dn/1lN2e/dJMcac3BAxn/Z96tHZBaCXjQ9giGKWwGgk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F1lN2e%2FdJMcac3BAxn%2FZ96tHZBaCXjQ9giGKWwGgk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="591" height="731" data-origin-width="591" data-origin-height="731"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">붙임_4._2025년+의약품+연속공정+예시모델+결과+CTD+보고서+(K+정제+2-습식과립)</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="547" data-origin-height="722"><span data-url="https://blog.kakaocdn.net/dn/bLNiCA/dJMcahqlyzM/k8jE6wXHKub5hH6NKke1l1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bLNiCA/dJMcahqlyzM/k8jE6wXHKub5hH6NKke1l1/img.png"><img src="https://blog.kakaocdn.net/dn/bLNiCA/dJMcahqlyzM/k8jE6wXHKub5hH6NKke1l1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbLNiCA%2FdJMcahqlyzM%2Fk8jE6wXHKub5hH6NKke1l1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="547" height="722" data-origin-width="547" data-origin-height="722"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">붙임_5._2025년+의약품+연속공정+적용을+위한+기초기술+결과+보고서</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="545" data-origin-height="726"><span data-url="https://blog.kakaocdn.net/dn/dpM5eE/dJMcafTBajC/88bkKK3342KmCFCaMylif0/img.png" data-phocus="https://blog.kakaocdn.net/dn/dpM5eE/dJMcafTBajC/88bkKK3342KmCFCaMylif0/img.png"><img src="https://blog.kakaocdn.net/dn/dpM5eE/dJMcafTBajC/88bkKK3342KmCFCaMylif0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FdpM5eE%2FdJMcafTBajC%2F88bkKK3342KmCFCaMylif0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="545" height="726" data-origin-width="545" data-origin-height="726"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​</span><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #000000; text-align: left;">의약품 연속공정 예시모델&middot;기초기술 개발</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16">다음의 파일은 분할압축된 것으로 전체 다운로드하여 압푹을 풀면 됩니다.</p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bH8YPZ/dJMcaiW2sGJ/o7W1l3mBgjKkc8p23sIbw1/%EC%9D%98%EC%95%BD%ED%92%88%20%EC%97%B0%EC%86%8D%EA%B3%B5%EC%A0%95%20%EC%98%88%EC%8B%9C%EB%AA%A8%EB%8D%B8%26middot%3B%EA%B8%B0%EC%B4%88%EA%B8%B0%EC%88%A0%20%EA%B0%9C%EB%B0%9C%20%EA%B2%B0%EA%B3%BC%20%EA%B3%B5%EA%B0%9C%20%EC%95%8C%EB%A6%BC.zip?attach=1&amp;knm=tfile.zip" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품 연속공정 예시모델&amp;middot;기초기술 개발 결과 공개 알림.zip</span></div> <div class="size">3.55MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bdwRqx/dJMcaiW2sHn/pY7ulGTplvGxZJtzSAKfGK/%EC%9D%98%EC%95%BD%ED%92%88%20%EC%97%B0%EC%86%8D%EA%B3%B5%EC%A0%95%20%EC%98%88%EC%8B%9C%EB%AA%A8%EB%8D%B8%26middot%3B%EA%B8%B0%EC%B4%88%EA%B8%B0%EC%88%A0%20%EA%B0%9C%EB%B0%9C%20%EA%B2%B0%EA%B3%BC%20%EA%B3%B5%EA%B0%9C%20%EC%95%8C%EB%A6%BC.z01?attach=1&amp;knm=tfile.z01" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품 연속공정 예시모델&amp;middot;기초기술 개발 결과 공개 알림.z01</span></div> <div class="size">19.53MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bXajnI/dJMcaiW2sHI/kLe2bvTgZh7AhJfBupKpC1/%EC%9D%98%EC%95%BD%ED%92%88%20%EC%97%B0%EC%86%8D%EA%B3%B5%EC%A0%95%20%EC%98%88%EC%8B%9C%EB%AA%A8%EB%8D%B8%26middot%3B%EA%B8%B0%EC%B4%88%EA%B8%B0%EC%88%A0%20%EA%B0%9C%EB%B0%9C%20%EA%B2%B0%EA%B3%BC%20%EA%B3%B5%EA%B0%9C%20%EC%95%8C%EB%A6%BC.z02?attach=1&amp;knm=tfile.z02" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품 연속공정 예시모델&amp;middot;기초기술 개발 결과 공개 알림.z02</span></div> <div class="size">19.53MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/v3W0h/dJMcabjnzA3/PVg7lWplrMn3g8uGbDNzi1/%EC%9D%98%EC%95%BD%ED%92%88%20%EC%97%B0%EC%86%8D%EA%B3%B5%EC%A0%95%20%EC%98%88%EC%8B%9C%EB%AA%A8%EB%8D%B8%26middot%3B%EA%B8%B0%EC%B4%88%EA%B8%B0%EC%88%A0%20%EA%B0%9C%EB%B0%9C%20%EA%B2%B0%EA%B3%BC%20%EA%B3%B5%EA%B0%9C%20%EC%95%8C%EB%A6%BC.z03?attach=1&amp;knm=tfile.z03" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품 연속공정 예시모델&amp;middot;기초기술 개발 결과 공개 알림.z03</span></div> <div class="size">19.53MB</div> </div> </a></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/fv6eQPvmroc?si=TeUetI_wm1dGG2Er" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/fv6eQPvmroc?si=TeUetI_wm1dGG2Er</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=fv6eQPvmroc" data-video-thumbnail="https://scrap.kakaocdn.net/dn/bVTpZB/dJMb8WMpOhV/j34sVO9lKJqSHbRL0Kjph1/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/KCvTu/dJMb8U8TNqI/Al72CEsJWERCEoibC6VoKK/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="당신이 매일 먹는 알약, 이렇게 만들어집니다 &mdash; 식약처가 공개한 제약 혁명의 실체" data-original-url=""><iframe src="https://www.youtube.com/embed/fv6eQPvmroc" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/law/policy/select/210765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">입법/행정 &middot; 한국제약바이오협회</a></p> <figure id="og_1774847446473" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/law/policy/select/210765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/oFIZW/dJMb8PGwaoy/VCc5iJVniQzRWm7tzADgN1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b2S2f6/dJMb8Z3rjkO/DCkAF9sLOeTKDca7QkxKvK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/y7E9Z/dJMb8T9ZuvM/PMoVoeysbSzm9cpkK1ZSe1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080"><a href="https://www.kpbma.or.kr/info/law/policy/select/210765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/law/policy/select/210765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/oFIZW/dJMb8PGwaoy/VCc5iJVniQzRWm7tzADgN1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b2S2f6/dJMb8Z3rjkO/DCkAF9sLOeTKDca7QkxKvK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/y7E9Z/dJMb8T9ZuvM/PMoVoeysbSzm9cpkK1ZSe1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 공정기술 바이오의약품 식품의약품안전처 연구개발 연속공정 의약품개발 의약품연속공정 의약품제조 제약공정 제약산업 빛별구 https://cnajini.tistory.com/587 https://cnajini.tistory.com/587#entry587comment Tue, 31 Mar 2026 15:12:11 +0900 https://cnajini.tistory.com/586 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">WHO 위탁시험계약 및 수행절차</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 WHO 위탁시험에 대한 세부 지침을 정한 것으로서 식품의약품안전처 관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">WHO 위탁시험계약 및 수행절차</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 23일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="509" data-origin-height="694"><span data-url="https://blog.kakaocdn.net/dn/dHNm7N/dJMcacJlU0f/fOA31365VSbxmC69kdaT01/img.png" data-phocus="https://blog.kakaocdn.net/dn/dHNm7N/dJMcacJlU0f/fOA31365VSbxmC69kdaT01/img.png"><img src="https://blog.kakaocdn.net/dn/dHNm7N/dJMcacJlU0f/fOA31365VSbxmC69kdaT01/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FdHNm7N%2FdJMcacJlU0f%2FfOA31365VSbxmC69kdaT01%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="509" height="694" data-origin-width="509" data-origin-height="694"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="521" data-origin-height="339"><span data-url="https://blog.kakaocdn.net/dn/bSVVHv/dJMcaaELJA5/Sg5wYzmx9kZ2ApwVuXEGR1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bSVVHv/dJMcaaELJA5/Sg5wYzmx9kZ2ApwVuXEGR1/img.png"><img src="https://blog.kakaocdn.net/dn/bSVVHv/dJMcaaELJA5/Sg5wYzmx9kZ2ApwVuXEGR1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbSVVHv%2FdJMcaaELJA5%2FSg5wYzmx9kZ2ApwVuXEGR1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="521" height="339" data-origin-width="521" data-origin-height="339"/></span></figure> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="506" data-origin-height="709"><span data-url="https://blog.kakaocdn.net/dn/PG2ST/dJMcacCzLEM/BsfHnxLA5rluYaLkgrAtkk/img.png" data-phocus="https://blog.kakaocdn.net/dn/PG2ST/dJMcacCzLEM/BsfHnxLA5rluYaLkgrAtkk/img.png"><img src="https://blog.kakaocdn.net/dn/PG2ST/dJMcacCzLEM/BsfHnxLA5rluYaLkgrAtkk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FPG2ST%2FdJMcacCzLEM%2FBsfHnxLA5rluYaLkgrAtkk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="506" height="709" data-origin-width="506" data-origin-height="709"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">WHO 위탁시험계약 및 수행절차</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/cl05Mu/dJMcacCzLGC/xuutZCqukBcaa9yH9G7tZK/%5B5300.05%5D%2BWHO%2B%EC%9C%84%ED%83%81%EC%8B%9C%ED%97%98%EA%B3%84%EC%95%BD%2B%EB%B0%8F%2B%EC%88%98%ED%96%89%EC%A0%88%EC%B0%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">[5300.05]+WHO+위탁시험계약+및+수행절차(공무원+지침서).pdf</span></div> <div class="size">1.58MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15236&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 who 공무원지침 국가출하승인 바이오의약품 백신품질시험 시험절차 식품의약품안전처 위탁시험 의약품규제 의약품시험 빛별구 https://cnajini.tistory.com/586 https://cnajini.tistory.com/586#entry586comment Mon, 30 Mar 2026 13:45:42 +0900 https://cnajini.tistory.com/585 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품의 비교 유효성 임상시험 수행 결정 시 고려 사항</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 동등생물의약품의 비교 유효성 임상시험 수행 결정 시 고려 사항에 대하여 알기 쉽게 설명하거나 식품의약품안전처의 입장을 기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품의 비교 유효성 임상시험 수행 결정 시 고려 사항</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 27일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="524" data-origin-height="736"><span data-url="https://blog.kakaocdn.net/dn/biCZ2a/dJMcadg7Y08/sVzqLldRA0SltuL3j0yNS0/img.png" data-phocus="https://blog.kakaocdn.net/dn/biCZ2a/dJMcadg7Y08/sVzqLldRA0SltuL3j0yNS0/img.png"><img src="https://blog.kakaocdn.net/dn/biCZ2a/dJMcadg7Y08/sVzqLldRA0SltuL3j0yNS0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbiCZ2a%2FdJMcadg7Y08%2FsVzqLldRA0SltuL3j0yNS0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="524" height="736" data-origin-width="524" data-origin-height="736"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="496" data-origin-height="381"><span data-url="https://blog.kakaocdn.net/dn/9Frkt/dJMcaciekiu/lI5vCzVVesQkNKf4PyrPWk/img.png" data-phocus="https://blog.kakaocdn.net/dn/9Frkt/dJMcaciekiu/lI5vCzVVesQkNKf4PyrPWk/img.png"><img src="https://blog.kakaocdn.net/dn/9Frkt/dJMcaciekiu/lI5vCzVVesQkNKf4PyrPWk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F9Frkt%2FdJMcaciekiu%2FlI5vCzVVesQkNKf4PyrPWk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="496" height="381" data-origin-width="496" data-origin-height="381"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="488" data-origin-height="655"><span data-url="https://blog.kakaocdn.net/dn/J8X1s/dJMcaiJs6qt/lKjXLzcNiMiFA7JF6PVM80/img.png" data-phocus="https://blog.kakaocdn.net/dn/J8X1s/dJMcaiJs6qt/lKjXLzcNiMiFA7JF6PVM80/img.png"><img src="https://blog.kakaocdn.net/dn/J8X1s/dJMcaiJs6qt/lKjXLzcNiMiFA7JF6PVM80/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FJ8X1s%2FdJMcaiJs6qt%2FlKjXLzcNiMiFA7JF6PVM80%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="488" height="655" data-origin-width="488" data-origin-height="655"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품의 비교 유효성 임상시험</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333; text-align: left;"><a href="https://youtu.be/7ycKayIHIGo?si=PmIZ-6WuuT4GPZVV" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/7ycKayIHIGo?si=PmIZ-6WuuT4GPZVV</a></span></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=7ycKayIHIGo" data-video-thumbnail="https://scrap.kakaocdn.net/dn/ca0Jhn/dJMb9b3RWpD/qRReUYAh0HE8eNvSmvWYNK/img.jpg?width=480&amp;height=360&amp;face=51_138_146_241,https://scrap.kakaocdn.net/dn/zr0Oe/dJMb9jOmPf7/KwSwkxebuWEK7mIYwgKxkK/img.jpg?width=480&amp;height=360&amp;face=51_138_146_241,https://scrap.kakaocdn.net/dn/biZbL4/dJMb8WezwdA/2tgiKn1z8UGKdpAXl9xk6K/img.jpg?width=480&amp;height=360&amp;face=51_138_146_241" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="당신이 먹는 약, 진짜 효과 있는 거 맞아요? | 식약처가 20년 만에 뒤집은 바이오시밀러 임상시험" data-original-url=""><iframe src="https://www.youtube.com/embed/7ycKayIHIGo" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/IyLfz/dJMcahX8aBd/ZCIVxQABRcp4qHKljumAv1/%EB%8F%99%EB%93%B1%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%EC%9D%98%2B%EB%B9%84%EA%B5%90%2B%EC%9C%A0%ED%9A%A8%EC%84%B1%2B%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%2B%EC%88%98%ED%96%89%2B%EA%B2%B0%EC%A0%95%2B%EC%8B%9C%2B%EA%B3%A0%EB%A0%A4%2B%EC%82%AC%ED%95%AD%28%EC%B5%9C%EC%A2%85%EB%B3%B8%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">동등생물의약품의+비교+유효성+임상시험+수행+결정+시+고려+사항(최종본).pdf</span></div> <div class="size">0.78MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15836&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 동등생물의약품 면역원성 바이오시밀러 바이오의약품 비교유효성임상시험 식품의약품안전처 약동학 의약품개발 임상시험가이드라인 품질동등성평가 빛별구 https://cnajini.tistory.com/585 https://cnajini.tistory.com/585#entry585comment Fri, 27 Mar 2026 10:39:02 +0900 https://cnajini.tistory.com/584 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 임상시험시 위해성 평가 기반 임신 검사 및 피임 가이드라인(민원인 안내서) 개정</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 의약품 임상시험에 참여하는 시험대상자의 피임 및 임신 검사 관련한 계획서 내 설정 사항에 대하여 알기 쉽게 설명하거나 식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 임상시험시 위해성 평가 기반 임신 검사 및 피임 가이드라인(민원인 안내서) 개정</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 20일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="524" data-origin-height="740"><span data-url="https://blog.kakaocdn.net/dn/sDRfp/dJMcajatrya/76MLJV1bW8MlWoWTBK2Swk/img.png" data-phocus="https://blog.kakaocdn.net/dn/sDRfp/dJMcajatrya/76MLJV1bW8MlWoWTBK2Swk/img.png"><img src="https://blog.kakaocdn.net/dn/sDRfp/dJMcajatrya/76MLJV1bW8MlWoWTBK2Swk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FsDRfp%2FdJMcajatrya%2F76MLJV1bW8MlWoWTBK2Swk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="524" height="740" data-origin-width="524" data-origin-height="740"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="523" data-origin-height="220"><span data-url="https://blog.kakaocdn.net/dn/9d8zM/dJMcafzczWt/dl84AUKKl6KURyFRd8afn0/img.png" data-phocus="https://blog.kakaocdn.net/dn/9d8zM/dJMcafzczWt/dl84AUKKl6KURyFRd8afn0/img.png"><img src="https://blog.kakaocdn.net/dn/9d8zM/dJMcafzczWt/dl84AUKKl6KURyFRd8afn0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F9d8zM%2FdJMcafzczWt%2Fdl84AUKKl6KURyFRd8afn0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="523" height="220" data-origin-width="523" data-origin-height="220"/></span></figure> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="529" data-origin-height="698"><span data-url="https://blog.kakaocdn.net/dn/k0mfq/dJMcadBh8KC/guvdbvPwoFssgCV62k9o80/img.png" data-phocus="https://blog.kakaocdn.net/dn/k0mfq/dJMcadBh8KC/guvdbvPwoFssgCV62k9o80/img.png"><img src="https://blog.kakaocdn.net/dn/k0mfq/dJMcadBh8KC/guvdbvPwoFssgCV62k9o80/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fk0mfq%2FdJMcadBh8KC%2FguvdbvPwoFssgCV62k9o80%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="529" height="698" data-origin-width="529" data-origin-height="698"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333; text-align: left;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 임상시험시 위해성 평가 기반 임신 검사 및 피임</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333; text-align: left;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16">[관련 유튜브 링크]</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/W38DkEFoc-Q?si=2-FfmTNOE7LbjlcJ" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/W38DkEFoc-Q?si=2-FfmTNOE7LbjlcJ</a></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/b81Ehe/dJMcadBh8K7/YdNOnkfzAkXKYSRayfOLXK/%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%EC%8B%9C%2B%EC%9C%84%ED%95%B4%EC%84%B1%2B%ED%8F%89%EA%B0%80%2B%EA%B8%B0%EB%B0%98%2B%EC%9E%84%EC%8B%A0%2B%EA%B2%80%EC%82%AC%2B%EB%B0%8F%2B%ED%94%BC%EC%9E%84%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29-%EA%B0%9C%EC%A0%95%EB%B3%B8.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품+임상시험시+위해성+평가+기반+임신+검사+및+피임+가이드라인(민원인+안내서)-개정본.pdf</span></div> <div class="size">0.41MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_218/view.do?seq=33706&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 GCP 바이오의약품 식품의약품안전처 위해성평가 의약품개발 의약품임상시험 임상시험 임상연구 임신검사 피임가이드라인 빛별구 https://cnajini.tistory.com/584 https://cnajini.tistory.com/584#entry584comment Mon, 23 Mar 2026 10:06:39 +0900 https://cnajini.tistory.com/583 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">2025 의약품 중 불순물 분석법 자료집</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 &lsquo;의약품 중 불순물 분석법 자료집&rsquo;은 식품의약품안전처에서 수행한 연구사업을 통해 시험방법의 유효성 확인(validation)을 실시한 분석법을 정리해 놓은&nbsp;것으로,&nbsp;관련&nbsp;산업계&nbsp;활용을&nbsp;위해&nbsp;제공할&nbsp;목적으로&nbsp;마련되었습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">2025 의약품 중 불순물 분석법 자료집</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 19일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="537" data-origin-height="779"><span data-url="https://blog.kakaocdn.net/dn/dl0Npv/dJMcahqcbNP/plUfnY6OiKijVTE9PCae2k/img.png" data-phocus="https://blog.kakaocdn.net/dn/dl0Npv/dJMcahqcbNP/plUfnY6OiKijVTE9PCae2k/img.png"><img src="https://blog.kakaocdn.net/dn/dl0Npv/dJMcahqcbNP/plUfnY6OiKijVTE9PCae2k/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fdl0Npv%2FdJMcahqcbNP%2FplUfnY6OiKijVTE9PCae2k%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="537" height="779" data-origin-width="537" data-origin-height="779"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="523" data-origin-height="240"><span data-url="https://blog.kakaocdn.net/dn/bjieUV/dJMb99Mqzf3/7aPkdiKqzr0lZ9lhAK06t1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bjieUV/dJMb99Mqzf3/7aPkdiKqzr0lZ9lhAK06t1/img.png"><img src="https://blog.kakaocdn.net/dn/bjieUV/dJMb99Mqzf3/7aPkdiKqzr0lZ9lhAK06t1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbjieUV%2FdJMb99Mqzf3%2F7aPkdiKqzr0lZ9lhAK06t1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="523" height="240" data-origin-width="523" data-origin-height="240"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;<span style="background-color: #ffffff; color: #333333;">​​​</span></p> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="513" data-origin-height="756"><span data-url="https://blog.kakaocdn.net/dn/bnuQQj/dJMcafeScKp/0q5y34f2kkKj3yCywctt8k/img.png" data-phocus="https://blog.kakaocdn.net/dn/bnuQQj/dJMcafeScKp/0q5y34f2kkKj3yCywctt8k/img.png"><img src="https://blog.kakaocdn.net/dn/bnuQQj/dJMcafeScKp/0q5y34f2kkKj3yCywctt8k/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbnuQQj%2FdJMcafeScKp%2F0q5y34f2kkKj3yCywctt8k%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="513" height="756" data-origin-width="513" data-origin-height="756"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="510" data-origin-height="475"><span data-url="https://blog.kakaocdn.net/dn/bTKcCA/dJMcacJcBlA/Iqrtre5Ghx51lkMK1fgjzK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bTKcCA/dJMcacJcBlA/Iqrtre5Ghx51lkMK1fgjzK/img.png"><img src="https://blog.kakaocdn.net/dn/bTKcCA/dJMcacJcBlA/Iqrtre5Ghx51lkMK1fgjzK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbTKcCA%2FdJMcacJcBlA%2FIqrtre5Ghx51lkMK1fgjzK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="510" height="475" data-origin-width="510" data-origin-height="475"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 중 불순물 분석법</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/F-YfbMJYsNs?si=VSsdAYD8cHgNJUBr" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/F-YfbMJYsNs?si=VSsdAYD8cHgNJUBr</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=F-YfbMJYsNs" data-video-thumbnail="https://scrap.kakaocdn.net/dn/4zPOa/dJMb9kT14cs/DLJpFJkJRrIQaF8xFKkM9k/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/bo30lQ/dJMb9lMaBVO/DQEBoVkEPkBUQBYlLQkeYK/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/mrQj7/dJMb9dHnakV/kyBbex585knPkKnLy91TGk/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720" data-video-width="860" data-video-height="484" data-video-origin-width="860" data-video-origin-height="484" data-ke-mobilestyle="widthContent" data-video-title="약장수도 모르는 '약 속 불순물' 잡는 법? 식약처 형님들이 빡친 이유 " data-original-url=""><iframe src="https://www.youtube.com/embed/F-YfbMJYsNs" width="860" height="484" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bOf4t3/dJMcagEPZZh/N5bexygCpMLAVdOTI2mEbk/2025%2B%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%A4%91%2B%EB%B6%88%EC%88%9C%EB%AC%BC%2B%EB%B6%84%EC%84%9D%EB%B2%95%2B%EC%9E%90%EB%A3%8C%EC%A7%91.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">2025+의약품+중+불순물+분석법+자료집.pdf</span></div> <div class="size">1.40MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_218/view.do?seq=33703&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1773882031700" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 | 식품의약품안전처" data-og-description="2025 의약품 중 불순물 분석법 자료집 우리 원(의약품연구과)에서는 의약품 중 불순물 분석 관련, 산업계 활용을 위해 제공할 목적으로 &lsquo;2025 의약품 중 불순물 분석법 자료집&rsquo; 개정본을 마련하" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_218/view.do?seq=33703&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_218/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=33703&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_218/view.do?seq=33703&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_218/view.do?seq=33703&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 | 식품의약품안전처</p> <p class="og-desc" data-ke-size="size16">2025 의약품 중 불순물 분석법 자료집 우리 원(의약품연구과)에서는 의약품 중 불순물 분석 관련, 산업계 활용을 위해 제공할 목적으로 &lsquo;2025 의약품 중 불순물 분석법 자료집&rsquo; 개정본을 마련하</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질관리(QC)/안내서_지침서 등 NDMA분석 니트로사민 불순물분석법 식약처가이드라인 식품의약품안전평가원 유전독성불순물 의약품불순물 의약품안전성 의약품품질관리 제약바이오 빛별구 https://cnajini.tistory.com/583 https://cnajini.tistory.com/583#entry583comment Thu, 19 Mar 2026 10:01:09 +0900 https://cnajini.tistory.com/582 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>[생물의약품] 바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 본 동향 정보집은 식품의약품안전평가원 용역연구개발과제로 수행한 ｢바이러스 벡터 기반 유전자치료제의 비특이적 유전체 삽입에 따른 안전성 평가 연구｣를 통해 획득&middot;수집한 정보를 바탕으로 하여, 관련분야&nbsp;연구&middot;개발자와&nbsp;심사&nbsp;관련&nbsp;종사자에게&nbsp;제공하기&nbsp;위한&nbsp;목적으로&nbsp;마련되었습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>[생물의약품] 바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 16일' 자로 식품의약품안전평가원의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="626" data-origin-height="832"><span data-url="https://blog.kakaocdn.net/dn/vX23E/dJMcaaR7FYm/BoiFUCgf9qwA8JFZqGBG51/img.png" data-phocus="https://blog.kakaocdn.net/dn/vX23E/dJMcaaR7FYm/BoiFUCgf9qwA8JFZqGBG51/img.png"><img src="https://blog.kakaocdn.net/dn/vX23E/dJMcaaR7FYm/BoiFUCgf9qwA8JFZqGBG51/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FvX23E%2FdJMcaaR7FYm%2FBoiFUCgf9qwA8JFZqGBG51%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="626" height="832" data-origin-width="626" data-origin-height="832"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="595" data-origin-height="739"><span data-url="https://blog.kakaocdn.net/dn/tndws/dJMcafTpMNd/YibzZmnLhE7SVxzRWqLwo1/img.png" data-phocus="https://blog.kakaocdn.net/dn/tndws/dJMcafTpMNd/YibzZmnLhE7SVxzRWqLwo1/img.png"><img src="https://blog.kakaocdn.net/dn/tndws/dJMcafTpMNd/YibzZmnLhE7SVxzRWqLwo1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Ftndws%2FdJMcafTpMNd%2FYibzZmnLhE7SVxzRWqLwo1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="595" height="739" data-origin-width="595" data-origin-height="739"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="620" data-origin-height="765"><span data-url="https://blog.kakaocdn.net/dn/cKbZxB/dJMcahcBWql/vJgXUfQZPTk5XxZTjVJutK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cKbZxB/dJMcahcBWql/vJgXUfQZPTk5XxZTjVJutK/img.png"><img src="https://blog.kakaocdn.net/dn/cKbZxB/dJMcahcBWql/vJgXUfQZPTk5XxZTjVJutK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcKbZxB%2FdJMcahcBWql%2FvJgXUfQZPTk5XxZTjVJutK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="620" height="765" data-origin-width="620" data-origin-height="765"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>[생물의약품] 바이러스 벡터 기반 유전자치료제의 연구개발 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/mpcpauvNWng?si=9s739I_Pt-EH3h_9" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/mpcpauvNWng?si=9s739I_Pt-EH3h_9</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=mpcpauvNWng" data-video-thumbnail="https://scrap.kakaocdn.net/dn/8az4U/dJMb81GV3Ba/SKzpk6eh2uBkR42K9Hb57k/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/sS9b2/dJMb88eZtPG/ArK2xoKqVwRLMSj1sAZWZk/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/OPClf/dJMb9c9wG5h/aUxN9TM1fKyJlAVGiAGLyk/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="&quot;무서운 바이러스가 착한 택배기사로?&quot; 유전자 치료제의 놀라운 반전! " data-original-url=""><iframe src="https://www.youtube.com/embed/mpcpauvNWng" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/z3RzJ/dJMcaaLkMkv/t1kVQVAbHP9qkTUy5mNKjk/%EB%B0%94%EC%9D%B4%EB%9F%AC%EC%8A%A4%EB%B2%A1%ED%84%B0%2B%EA%B8%B0%EB%B0%98%2B%EC%9C%A0%EC%A0%84%EC%9E%90%EC%B9%98%EB%A3%8C%EC%A0%9C%EC%9D%98%2B%EC%97%B0%EA%B5%AC%EA%B0%9C%EB%B0%9C%2B%EB%8F%99%ED%96%A5%2B%EC%A0%95%EB%B3%B4%EC%A7%91.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">바이러스벡터+기반+유전자치료제의+연구개발+동향+정보집.pdf</span></div> <div class="size">8.20MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12867">정보마당 &gt; 간행물&middot;자료집 &gt; 바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집 | 식품의약품안전평가원</a></p> <figure id="og_1773708808830" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="정보마당 &gt; 간행물&middot;자료집 &gt; 바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집 | 식품의" data-og-description="첨단바이오융복합연구과 주관의 용역연구개발과제 수행을 통해 '바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집'을 발간하였습니다. 관련 분야 연구 개발자와 심사 관련 종사자에게" data-og-host="www.nifds.go.kr" data-og-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12867" data-og-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12867" data-og-image=""><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12867" target="_blank" rel="noopener" data-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12867"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">정보마당 &gt; 간행물&middot;자료집 &gt; 바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집 | 식품의</p> <p class="og-desc" data-ke-size="size16">첨단바이오융복합연구과 주관의 용역연구개발과제 수행을 통해 '바이러스 벡터 기반 유전자치료제의 연구개발 동향 정보집'을 발간하였습니다. 관련 분야 연구 개발자와 심사 관련 종사자에게</p> <p class="og-host" data-ke-size="size16">www.nifds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 레트로바이러스 바이러스벡터 바이오신약개발 세포유전자치료제 식약처가이드라인 식품의약품안전평가원 아데노부속바이러스 유전자치료제 유전자치료제동향 첨단바이오의약품 빛별구 https://cnajini.tistory.com/582 https://cnajini.tistory.com/582#entry582comment Tue, 17 Mar 2026 09:53:48 +0900 https://cnajini.tistory.com/581 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인의약품 위해도 단계 평가 세부지침</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 &lsquo;국가출하승인의약품 위해도 단계 평가&rsquo;의 세부 지침을 정한 것으로서&nbsp;식약처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인의약품 위해도 단계 평가 세부지침</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 09일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="526" data-origin-height="727"><span data-url="https://blog.kakaocdn.net/dn/cXqD9t/dJMcacWAL9V/bbu9uFrVhEdpE3JQdVp3kK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cXqD9t/dJMcacWAL9V/bbu9uFrVhEdpE3JQdVp3kK/img.png"><img src="https://blog.kakaocdn.net/dn/cXqD9t/dJMcacWAL9V/bbu9uFrVhEdpE3JQdVp3kK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcXqD9t%2FdJMcacWAL9V%2Fbbu9uFrVhEdpE3JQdVp3kK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="526" height="727" data-origin-width="526" data-origin-height="727"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="527" data-origin-height="663"><span data-url="https://blog.kakaocdn.net/dn/ciLoe2/dJMcagxU6SL/1tY0XULaSJkFR4vZCYy740/img.png" data-phocus="https://blog.kakaocdn.net/dn/ciLoe2/dJMcagxU6SL/1tY0XULaSJkFR4vZCYy740/img.png"><img src="https://blog.kakaocdn.net/dn/ciLoe2/dJMcagxU6SL/1tY0XULaSJkFR4vZCYy740/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FciLoe2%2FdJMcagxU6SL%2F1tY0XULaSJkFR4vZCYy740%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="527" height="663" data-origin-width="527" data-origin-height="663"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인의약품 위해도 단계 평가</span> </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/ch9kmWQUnyU" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/ch9kmWQUnyU</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=ch9kmWQUnyU" data-video-thumbnail="https://scrap.kakaocdn.net/dn/4igsf/dJMb85WRVDF/GRoTKKEdWit0g64F5edQxK/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/bW0G9n/dJMb83krybw/nJ0fUDfK0rrOYQLBDUtem0/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/bJMq9G/dJMb83ShrWQ/r0TmXk5e0LH5KqLy0zMmgk/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="백신마다 검사 강도가 다르다? 식약처의 '등급제' 비밀 (2026 최신 지침)" data-original-url=""><iframe src="https://www.youtube.com/embed/ch9kmWQUnyU" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/NxDXk/dJMcacWAMaX/mn8n50dUk45plprKsP05w1/%282026%29%2B%EA%B5%AD%EA%B0%80%EC%B6%9C%ED%95%98%EC%8A%B9%EC%9D%B8%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%9C%84%ED%95%B4%EB%8F%84%2B%EB%8B%A8%EA%B3%84%2B%ED%8F%89%EA%B0%80%2B%EC%84%B8%EB%B6%80%EC%A7%80%EC%B9%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(2026)+국가출하승인의약품+위해도+단계+평가+세부지침(공무원지침서).pdf</span></div> <div class="size">1.20MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_218/view.do?seq=33699&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 GMP실태조사 국가출하승인 바이오의약품 백신품질관리 생물학적제제 식약처지침서 식품의약품안전처 위해도평가 의약품품질관리 혈액제제 빛별구 https://cnajini.tistory.com/581 https://cnajini.tistory.com/581#entry581comment Mon, 16 Mar 2026 11:51:40 +0900 https://cnajini.tistory.com/580 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 2월(하))」 배포 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1297" data-origin-height="193"><span data-url="https://blog.kakaocdn.net/dn/c5MoVg/dJMcabi6gPA/4VtIRhkpU7lPIn2Kwu3y1K/img.png" data-phocus="https://blog.kakaocdn.net/dn/c5MoVg/dJMcabi6gPA/4VtIRhkpU7lPIn2Kwu3y1K/img.png"><img src="https://blog.kakaocdn.net/dn/c5MoVg/dJMcabi6gPA/4VtIRhkpU7lPIn2Kwu3y1K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fc5MoVg%2FdJMcabi6gPA%2F4VtIRhkpU7lPIn2Kwu3y1K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1297" height="193" data-origin-width="1297" data-origin-height="193"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 2월(하))」 배포 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="579" data-origin-height="798"><span data-url="https://blog.kakaocdn.net/dn/bpy9yD/dJMcaiWLuCf/bgHkGLoSKYlPRqhtPyyHrk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bpy9yD/dJMcaiWLuCf/bgHkGLoSKYlPRqhtPyyHrk/img.png"><img src="https://blog.kakaocdn.net/dn/bpy9yD/dJMcaiWLuCf/bgHkGLoSKYlPRqhtPyyHrk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbpy9yD%2FdJMcaiWLuCf%2FbgHkGLoSKYlPRqhtPyyHrk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="579" height="798" data-origin-width="579" data-origin-height="798"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span>​</span><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="536" data-origin-height="740"><span data-url="https://blog.kakaocdn.net/dn/pvSSj/dJMcaiPZokv/vO54Kwhu0LNLvl1tgdccQk/img.png" data-phocus="https://blog.kakaocdn.net/dn/pvSSj/dJMcaiPZokv/vO54Kwhu0LNLvl1tgdccQk/img.png"><img src="https://blog.kakaocdn.net/dn/pvSSj/dJMcaiPZokv/vO54Kwhu0LNLvl1tgdccQk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FpvSSj%2FdJMcaiPZokv%2FvO54Kwhu0LNLvl1tgdccQk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="536" height="740" data-origin-width="536" data-origin-height="740"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #ffffff; color: #333333; text-align: left;">의료제품 분야, 최신 해외 동향 정보</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/CbHx0/dJMcac3kgGL/qdh4QlnLU6KRLcpLoxCMl1/1.%20%EC%9D%98%EB%A3%8C%EC%A0%9C%ED%92%88%20%EB%B6%84%EC%95%BC%2C%20%EC%B5%9C%EC%8B%A0%20%ED%95%B4%EC%99%B8%20%EB%8F%99%ED%96%A5%20%EC%A0%95%EB%B3%B4%EC%A7%80%282026%EB%85%84%202%EC%9B%94%20%28%ED%95%98%29%2C%20vol.%2026%29_%EC%9D%98%EC%95%BD%ED%92%88.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">1. 의료제품 분야, 최신 해외 동향 정보지(2026년 2월 (하), vol. 26)_의약품.pdf</span></div> <div class="size">0.96MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/cAlh01/dJMcaadpFVF/iXmkCp8UVJ0nu6jE8XIuu1/2.%20%EC%9D%98%EB%A3%8C%EC%A0%9C%ED%92%88%20%EB%B6%84%EC%95%BC%2C%20%EC%B5%9C%EC%8B%A0%20%ED%95%B4%EC%99%B8%20%EB%8F%99%ED%96%A5%20%EC%A0%95%EB%B3%B4%EC%A7%80%282026%EB%85%84%202%EC%9B%94%20%28%ED%95%98%29%2C%20vol.%2026%29_%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">2. 의료제품 분야, 최신 해외 동향 정보지(2026년 2월 (하), vol. 26)_의료기기.pdf</span></div> <div class="size">0.76MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/crPOc6/dJMcah4FxVK/KredpvTf2o4kxksxZxgtB1/3.%20%EC%9D%98%EB%A3%8C%EC%A0%9C%ED%92%88%20%EB%B6%84%EC%95%BC%2C%20%EC%B5%9C%EC%8B%A0%20%ED%95%B4%EC%99%B8%20%EB%8F%99%ED%96%A5%20%EC%A0%95%EB%B3%B4%EC%A7%80%282026%EB%85%84%202%EC%9B%94%20%28%ED%95%98%29%2C%20vol.%2026%29_%ED%99%94%EC%9E%A5%ED%92%88.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">3. 의료제품 분야, 최신 해외 동향 정보지(2026년 2월 (하), vol. 26)_화장품.pdf</span></div> <div class="size">0.61MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248824?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">공지사항 &middot; 한국제약바이오협회</a></p> <figure id="og_1773023006771" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248824?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/hcZNo/dJMb82eK73E/zxo2ATkb4Dsmn5o8O0IIg0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/bL2vKq/dJMb86nVCNY/oykR5OkBJAlbcmSpFuP3JK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/CHR2x/dJMb9gxjuaG/u1EKLgeZyQ0LsZxvZ56Xr1/img.png?width=765&amp;height=640&amp;face=0_0_765_640"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248824?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248824?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/hcZNo/dJMb82eK73E/zxo2ATkb4Dsmn5o8O0IIg0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/bL2vKq/dJMb86nVCNY/oykR5OkBJAlbcmSpFuP3JK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/CHR2x/dJMb9gxjuaG/u1EKLgeZyQ0LsZxvZ56Xr1/img.png?width=765&amp;height=640&amp;face=0_0_765_640');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/580 https://cnajini.tistory.com/580#entry580comment Sun, 15 Mar 2026 12:23:42 +0900 https://cnajini.tistory.com/579 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의료용 마약류 진통제 안전사용 기준</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는&nbsp; 의료용 마약류의 안전한 사용(처방&middot;투약)에 대한 식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의료용 마약류 진통제 안전사용 기준</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="678"><span data-url="https://blog.kakaocdn.net/dn/tfxS6/dJMcaiWLt8g/yovs9eZ5dvuifPLO9RXGn1/img.png" data-phocus="https://blog.kakaocdn.net/dn/tfxS6/dJMcaiWLt8g/yovs9eZ5dvuifPLO9RXGn1/img.png"><img src="https://blog.kakaocdn.net/dn/tfxS6/dJMcaiWLt8g/yovs9eZ5dvuifPLO9RXGn1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FtfxS6%2FdJMcaiWLt8g%2Fyovs9eZ5dvuifPLO9RXGn1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="678" data-origin-width="535" data-origin-height="678"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="545" data-origin-height="328"><span data-url="https://blog.kakaocdn.net/dn/cGVbF3/dJMcahXTrj4/Jja9Fg1Udj9DKqB6Ld5tI1/img.png" data-phocus="https://blog.kakaocdn.net/dn/cGVbF3/dJMcahXTrj4/Jja9Fg1Udj9DKqB6Ld5tI1/img.png"><img src="https://blog.kakaocdn.net/dn/cGVbF3/dJMcahXTrj4/Jja9Fg1Udj9DKqB6Ld5tI1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcGVbF3%2FdJMcahXTrj4%2FJja9Fg1Udj9DKqB6Ld5tI1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="545" height="328" data-origin-width="545" data-origin-height="328"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="548" data-origin-height="745"><span data-url="https://blog.kakaocdn.net/dn/tvGgW/dJMcaaqWsof/7am4YyhqKR3C3iby6uMYik/img.png" data-phocus="https://blog.kakaocdn.net/dn/tvGgW/dJMcaaqWsof/7am4YyhqKR3C3iby6uMYik/img.png"><img src="https://blog.kakaocdn.net/dn/tvGgW/dJMcaaqWsof/7am4YyhqKR3C3iby6uMYik/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FtvGgW%2FdJMcaaqWsof%2F7am4YyhqKR3C3iby6uMYik%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="548" height="745" data-origin-width="548" data-origin-height="745"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의료용 마약류 진통제 안전사용 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><a href="https://youtu.be/SuT8mm5p3HM?si=T9tn8uL1XZ3qG5TV" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/SuT8mm5p3HM?si=T9tn8uL1XZ3qG5TV</a></span></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=SuT8mm5p3HM" data-video-thumbnail="https://scrap.kakaocdn.net/dn/eFNzp/dJMb83ShrpB/mYY0bSEtK3HYgp7pguh7dk/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/cSRDwT/dJMb86nV9Ux/yJAaYjyGDzfDydpgTmO2gK/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/bKbfNO/dJMb83ShrpC/S3dQJXOiAvkDpkS5IHviw0/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720" data-video-width="860" data-video-height="484" data-video-origin-width="860" data-video-origin-height="484" data-ke-mobilestyle="widthContent" data-video-title="모르면 독이 되는 마약류 진통제 &quot;이것&quot; 모르면 절대 복용하지 마세요! (펜타닐, 옥시코돈 등)" data-original-url=""><iframe src="https://www.youtube.com/embed/SuT8mm5p3HM" width="860" height="484" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/cqyqny/dJMcacWzkAl/S20UtpvrpTVl3jGuG1gnT0/%EC%9D%98%EB%A3%8C%EC%9A%A9%2B%EB%A7%88%EC%95%BD%EB%A5%98%2B%EC%A7%84%ED%86%B5%EC%A0%9C%2B%EC%95%88%EC%A0%84%EC%82%AC%EC%9A%A9%2B%EA%B8%B0%EC%A4%80.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의료용+마약류+진통제+안전사용+기준.pdf</span></div> <div class="size">0.44MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_218/view.do?seq=33698&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;자료실&gt;안내서/지침 - 상세보기 | 식품의약품안전처</a></p> </div> 품질보증(QA)/안내서_지침서 등 마약류안전사용기준 마약성진통제 식약처가이드라인 식품의약품안전처 오남용방지 의료용마약류 의료제품안내서 의약품안전관리 진통제처방기준 펜타닐패치 빛별구 https://cnajini.tistory.com/579 https://cnajini.tistory.com/579#entry579comment Sat, 14 Mar 2026 12:07:56 +0900 https://cnajini.tistory.com/578 <h4 data-path-to-node="7" data-ke-size="size20"><b data-index-in-node="0" data-path-to-node="7">1. 개요: 생물의약품 및 한약(생약)제제 심사 검토서란?</b></h4> <p id="p-rc_a38e2bc307c15f68-142" data-path-to-node="8" data-ke-size="size16"><span data-path-to-node="8,0">의약품의 품목 허가나 변경 허가를 신청할 때, 식약처 심사관들은 제출된 자료를 바탕으로 심사 검토서를 작성합니다. </span><span data-path-to-node="8,1"></span><span data-path-to-node="8,2"><span>이 지침서는 심사 업무의 전문성, 일관성, 투명성을 확보하기 위해 검토서의 작성 양식과 세부 기준을 표준화한 공무원 지침서입니다. </span></span><span data-path-to-node="8,3"><span></span></span></p> <div><img style="text-align: center; caret-color: transparent; letter-spacing: 0px;" src="https://blog.kakaocdn.net/dna/PUhQT/dJMcahjmH1C/AAAAAAAAAAAAAAAAAAAAAIiqXNqMGHw4a6gavpcTXqh70N6xtaYPGUYU85a967Ht/img.png?credential=yqXZFxpELC7KVnFOS48ylbz2pIh7yKj8&amp;expires=1774969199&amp;allow_ip=&amp;allow_referer=&amp;signature=F%2BYS0uP%2BSlGvi1a%2B%2FGA%2FPCFHzfY%3D" data-origin-width="1536" data-origin-height="1024" data-is-animation="false" /></div> <h4 data-path-to-node="9" data-ke-size="size20"><b data-index-in-node="0" data-path-to-node="9">2. 주요 목적 및 관련 법령</b></h4> <ul style="list-style-type: disc;" data-path-to-node="10" data-ke-list-type="disc"> <li id="p-rc_a38e2bc307c15f68-143" data-path-to-node="10,0,1"><span data-path-to-node="10,0,1,0"><b data-index-in-node="0" data-path-to-node="10,0,1,0"><span>목적:</span></b><span> 생물의약품 및 한약(생약)제제의 허가&middot;심사 업무 기준을 표준화하여 심사 결과의 정확성과 신뢰도를 높이기 위함입니다.</span></span></li> <li id="p-rc_a38e2bc307c15f68-144" data-path-to-node="10,1,1"><span data-path-to-node="10,1,1,0"><b data-index-in-node="0" data-path-to-node="10,1,1,0"><span>근거 법령:</span></b><span> 「약사법」, 「첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률」, 「생물학적제제 등의 품목허가&middot;심사 규정」 등을 바탕으로 합니다.</span></span><span data-path-to-node="10,1,1,0"><span></span></span></li> </ul> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1536" data-origin-height="1024"><span data-url="https://blog.kakaocdn.net/dn/YBiJF/dJMcaflwiIf/BM3Y3bicdZroypmaxqf9FK/img.png" data-phocus="https://blog.kakaocdn.net/dn/YBiJF/dJMcaflwiIf/BM3Y3bicdZroypmaxqf9FK/img.png"><img src="https://blog.kakaocdn.net/dn/YBiJF/dJMcaflwiIf/BM3Y3bicdZroypmaxqf9FK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FYBiJF%2FdJMcaflwiIf%2FBM3Y3bicdZroypmaxqf9FK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1536" height="1024" data-origin-width="1536" data-origin-height="1024"/></span></figure> </p> <h4 data-path-to-node="11" data-ke-size="size20"><b data-index-in-node="0" data-path-to-node="11">3. 심사 검토서의 핵심 구성 요소</b></h4> <p id="p-rc_a38e2bc307c15f68-145" data-path-to-node="12" data-ke-size="size16"><span data-path-to-node="12,0"></span><span data-path-to-node="12,1"><span>심사 검토서는 크게 두 가지 영역으로 나뉘어 작성됩니다. </span></span><span data-path-to-node="12,2"><span></span></span></p> <ul style="list-style-type: disc;" data-path-to-node="13,0,2" data-ke-list-type="disc"> <li><span data-path-to-node="13,0,2,0,0,0"></span><span data-path-to-node="13,0,2,0,0,1"><span>신청 제품의 효능&middot;효과, 용법&middot;용량, 저장방법 등 기재 </span></span><span data-path-to-node="13,0,2,0,0,2"><span></span></span></li> <li><span data-path-to-node="13,0,2,1,0,0"></span><span data-path-to-node="13,0,2,1,0,1"><span>임상시험 성적 자료 및 비임상 자료 검토 결과 </span></span><span data-path-to-node="13,0,2,1,0,2"><span></span></span></li> <li><span data-path-to-node="13,0,2,2,0,0"></span><span data-path-to-node="13,0,2,2,0,1"><span>기허가 사항 및 국내외 사용 현황 비교 </span></span><span data-path-to-node="13,0,2,2,0,2"><span></span></span></li> </ul> <p data-ke-size="size16">&nbsp;</p> <ul style="list-style-type: disc;" data-path-to-node="13,0,2" data-ke-list-type="disc"> <li id="p-rc_a38e2bc307c15f68-146" data-path-to-node="13,0,1"><span data-path-to-node="13,0,1,0"><b data-index-in-node="0" data-path-to-node="13,0,1,0"><span>안전성&middot;유효성 심사 검토서 (안유):</span></b></span> <ul style="list-style-type: disc;" data-path-to-node="13,1,2" data-ke-list-type="disc"> <li><span data-path-to-node="13,1,2,0,0,0"></span><span data-path-to-node="13,1,2,0,0,1"><span>원료의약품 및 완제의약품의 제조방법, 규격 설정 근거 </span></span><span data-path-to-node="13,1,2,0,0,2"><span></span></span></li> <li><span data-path-to-node="13,1,2,1,0,0"></span><span data-path-to-node="13,1,2,1,0,1"><span>물리화학적 성질 및 구조 결정 자료 </span></span><span data-path-to-node="13,1,2,1,0,2"><span></span></span></li> <li><span data-path-to-node="13,1,2,2,0,0"></span><span data-path-to-node="13,1,2,2,0,1"><span>공정 밸리데이션 및 안정성 시험 결과 검토 </span></span><span data-path-to-node="13,1,2,2,0,2"><span></span></span><span data-path-to-node="13,1,1,0"><b data-index-in-node="0" data-path-to-node="13,1,1,0"><span></span></b></span><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1536" data-origin-height="1024"><span data-url="https://blog.kakaocdn.net/dn/bvlUj7/dJMcafeMQkt/5ZvGCwr4NCUV8gr6EEtKe1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bvlUj7/dJMcafeMQkt/5ZvGCwr4NCUV8gr6EEtKe1/img.png"><img src="https://blog.kakaocdn.net/dn/bvlUj7/dJMcafeMQkt/5ZvGCwr4NCUV8gr6EEtKe1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbvlUj7%2FdJMcafeMQkt%2F5ZvGCwr4NCUV8gr6EEtKe1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1536" height="1024" data-origin-width="1536" data-origin-height="1024"/></span></figure> </li> </ul> </li> <li><span data-path-to-node="13,1,1,0"><b data-index-in-node="0" data-path-to-node="13,1,1,0"><span>기준 및 시험방법 심사 검토서 (품질):</span></b><span> </span></span><span data-path-to-node="13,1,1,1"><span></span></span><span data-path-to-node="13,1,1,0"><b data-index-in-node="0" data-path-to-node="13,1,1,0"><span></span></b></span></li> </ul> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1536" data-origin-height="1024"><span data-url="https://blog.kakaocdn.net/dn/cChA1k/dJMcabi8Tez/kmB6bI3rwP7PhYcdmUWeCk/img.png" data-phocus="https://blog.kakaocdn.net/dn/cChA1k/dJMcabi8Tez/kmB6bI3rwP7PhYcdmUWeCk/img.png"><img src="https://blog.kakaocdn.net/dn/cChA1k/dJMcabi8Tez/kmB6bI3rwP7PhYcdmUWeCk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcChA1k%2FdJMcabi8Tez%2FkmB6bI3rwP7PhYcdmUWeCk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1536" height="1024" data-origin-width="1536" data-origin-height="1024"/></span></figure> </p> <h4 data-path-to-node="14" data-ke-size="size20"><b data-index-in-node="0" data-path-to-node="14">4. 심사 절차 및 보완 관리</b></h4> <div>&nbsp;</div> <ol style="list-style-type: decimal;" data-path-to-node="15" data-ke-list-type="decimal"> <li id="p-rc_a38e2bc307c15f68-154" data-path-to-node="15,0,1"><span data-path-to-node="15,0,1,0"><b data-index-in-node="0" data-path-to-node="15,0,1,0"><span>접수 및 배정:</span></b><span> 허가부서의 협의 의뢰에 따라 심사 담당자가 지정됩니다. </span></span><span data-path-to-node="15,0,1,1"><span></span></span><br /> <div>&nbsp;</div> </li> <li id="p-rc_a38e2bc307c15f68-155" data-path-to-node="15,1,1"><span data-path-to-node="15,1,1,0"><b data-index-in-node="0" data-path-to-node="15,1,1,0"><span>심사 수행:</span></b><span> 관련 규정에 따라 과학적 타당성을 심사하고 검토서를 작성합니다. </span></span><span data-path-to-node="15,1,1,1"><span></span></span><br /> <div>&nbsp;</div> </li> <li id="p-rc_a38e2bc307c15f68-156" data-path-to-node="15,2,1"><span data-path-to-node="15,2,1,0"><b data-index-in-node="0" data-path-to-node="15,2,1,0"><span>보완 요청:</span></b><span> 자료가 미흡할 경우 '보완요청사항'을 작성하여 민원인에게 알립니다. </span></span><span data-path-to-node="15,2,1,1"><span></span></span><br /> <div>&nbsp;</div> </li> <li id="p-rc_a38e2bc307c15f68-157" data-path-to-node="15,3,1"><span data-path-to-node="15,3,1,0"><b data-index-in-node="0" data-path-to-node="15,3,1,0"><span>최종 회신:</span></b><span> 보완 이행 결과를 확인한 후 '적합', '부적합' 등의 최종 의견을 회신합니다.</span></span></li> </ol> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1536" data-origin-height="1024"><span data-url="https://blog.kakaocdn.net/dn/bundDI/dJMcaibuGr3/ZjlRceLsKwhdHPsvChK5lk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bundDI/dJMcaibuGr3/ZjlRceLsKwhdHPsvChK5lk/img.png"><img src="https://blog.kakaocdn.net/dn/bundDI/dJMcaibuGr3/ZjlRceLsKwhdHPsvChK5lk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbundDI%2FdJMcaibuGr3%2FZjlRceLsKwhdHPsvChK5lk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1536" height="1024" data-origin-width="1536" data-origin-height="1024"/></span></figure> </p> <h4 data-path-to-node="16" data-ke-size="size20"><b data-index-in-node="0" data-path-to-node="16">5. 실무자를 위한 팁</b></h4> <ul style="list-style-type: disc;" data-path-to-node="17" data-ke-list-type="disc"> <li id="p-rc_a38e2bc307c15f68-158" data-path-to-node="17,0,1"><span data-path-to-node="17,0,1,0"><b data-index-in-node="0" data-path-to-node="17,0,1,0"><span>기재 방식:</span></b><span> 검토 의견은 간결하면서도 타당성 여부를 명확히 판단할 수 있도록 구체적인 근거(예: OO임상시험 결과 등)를 포함해야 합니다. </span></span><span data-path-to-node="17,0,1,1"><span></span></span></li> <li><span data-path-to-node="17,1,1,0"><b data-index-in-node="0" data-path-to-node="17,1,1,0"><span>시정 사항 확인:</span></b><span> 효능&middot;효과나 사용상의 주의사항 등은 '의약품 허가사항 작성지침'에 따라 국어기본법에 맞게 정확히 작성되었는지 점검이 필요합니다. </span></span><span data-path-to-node="17,1,1,1"><span></span></span></li> </ul> <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1536" data-origin-height="1024"><span data-url="https://blog.kakaocdn.net/dn/d6QQol/dJMcaaqY08z/vKppq42gqYxwWgVYlds5Dk/img.png" data-phocus="https://blog.kakaocdn.net/dn/d6QQol/dJMcaaqY08z/vKppq42gqYxwWgVYlds5Dk/img.png"><img src="https://blog.kakaocdn.net/dn/d6QQol/dJMcaaqY08z/vKppq42gqYxwWgVYlds5Dk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fd6QQol%2FdJMcaaqY08z%2FvKppq42gqYxwWgVYlds5Dk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1536" height="1024" data-origin-width="1536" data-origin-height="1024"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"> <span data-path-to-node="22,0"><b data-index-in-node="0" data-path-to-node="22,0">참고 사항:</b> </span><span data-path-to-node="22,1"></span><span data-path-to-node="22,2"><span>이 글은 업로드하신 </span><b data-index-in-node="11" data-path-to-node="22,2"><span>'생물의약품&middot;한약(생약)제제 심사 검토서 작성 요령(Rev 7, 2026. 3.)'</span></b><span> 문서를 토대로 작성되었습니다. </span></span><span data-path-to-node="22,3"><span></span></span><span data-path-to-node="22,4"></span><span data-path-to-node="22,5"><span>해당 지침서는 공무원 내부 지침용으로 대외적인 법적 효력은 없으나, 실무 참고용으로 매우 중요한 자료입니다.</span></span> </span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/yc8wX7IgtYA?si=NDdGZU0ZTtanyfFT" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/yc8wX7IgtYA?si=NDdGZU0ZTtanyfFT</a></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> </div> </div> </div> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=yc8wX7IgtYA" data-video-thumbnail="https://scrap.kakaocdn.net/dn/pxspL/dJMb8SpGzBd/bUpsIkYPIJsFZeiTe7tXJK/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/bbBQR5/dJMb8XR4gtj/6hIuFTSLpmtFqRTiqsX4F0/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720,https://scrap.kakaocdn.net/dn/KH1hk/dJMb8QekOGK/jx9zPXBhuZcNL6P0B6pV31/img.jpg?width=1280&amp;height=720&amp;face=0_0_1280_720" data-video-width="860" data-video-height="484" data-video-origin-width="860" data-video-origin-height="484" data-ke-mobilestyle="widthContent" data-video-title="식약처 심사관처럼 검토서 쓰는 법 생물의약품&middot;한약(생약)제제 심사 검토서 작성 요령 완벽 " data-original-url=""><iframe src="https://www.youtube.com/embed/yc8wX7IgtYA" width="860" height="484" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p data-ke-size="size16">&nbsp;</p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/n3Aed/dJMcai3vSjo/xzNkrPQWT7y5gub5kLXye0/%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%2B%ED%95%9C%EC%95%BD%28%EC%83%9D%EC%95%BD%29%EC%A0%9C%EC%A0%9C%2B%EC%8B%AC%EC%82%AC%2B%EA%B2%80%ED%86%A0%EC%84%9C%2B%EC%9E%91%EC%84%B1%2B%EC%9A%94%EB%A0%B9%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">생물의약품+한약(생약)제제+심사+검토서+작성+요령(공무원+지침서).pdf</span></div> <div class="size">1.91MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15235&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1773021865221" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="생물의약품 한약(생약)제제 심사 검토서 작성 요령 등록번호 지침서-0165-07 분야 모바일서비스 Y 고시일 2026-03-05 등록일 2026-03-06 조회수 128 첨부파일 첨부파일 전체 다운로드 --&gt; 생물의약품 한약(" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15235&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15235&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15235&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15235&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">생물의약품 한약(생약)제제 심사 검토서 작성 요령 등록번호 지침서-0165-07 분야 모바일서비스 Y 고시일 2026-03-05 등록일 2026-03-06 조회수 128 첨부파일 첨부파일 전체 다운로드 --&gt; 생물의약품 한약(</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> </div> 품질보증(QA)/안내서_지침서 등 #식약처지침서 #생물의약품 #한약제제 #의약품허가심사 #제약실무 #안전성유효성 #기준및시험방법 #RA #제약바이오 빛별구 https://cnajini.tistory.com/578 https://cnajini.tistory.com/578#entry578comment Fri, 13 Mar 2026 12:04:40 +0900 https://cnajini.tistory.com/577 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 심사자 교육훈련</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는&nbsp; 바이오생약심사부 심사자 교육훈련의 세부 지침을 정한것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 심사자 교육훈련</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="559" data-origin-height="733"><span data-url="https://blog.kakaocdn.net/dn/BBIIA/dJMcad2cXui/XgUYA3bMz01buHSTo9d8d0/img.png" data-phocus="https://blog.kakaocdn.net/dn/BBIIA/dJMcad2cXui/XgUYA3bMz01buHSTo9d8d0/img.png"><img src="https://blog.kakaocdn.net/dn/BBIIA/dJMcad2cXui/XgUYA3bMz01buHSTo9d8d0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FBBIIA%2FdJMcad2cXui%2FXgUYA3bMz01buHSTo9d8d0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="559" height="733" data-origin-width="559" data-origin-height="733"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="529" data-origin-height="363"><span data-url="https://blog.kakaocdn.net/dn/bpRIdB/dJMcadnCvD7/4u65XMUY5e5d7GFOmTnE50/img.png" data-phocus="https://blog.kakaocdn.net/dn/bpRIdB/dJMcadnCvD7/4u65XMUY5e5d7GFOmTnE50/img.png"><img src="https://blog.kakaocdn.net/dn/bpRIdB/dJMcadnCvD7/4u65XMUY5e5d7GFOmTnE50/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbpRIdB%2FdJMcadnCvD7%2F4u65XMUY5e5d7GFOmTnE50%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="529" height="363" data-origin-width="529" data-origin-height="363"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="531" data-origin-height="292"><span data-url="https://blog.kakaocdn.net/dn/dr7wfl/dJMcafZ3AVt/kOiS8O8BSHAYfPTm1B77ZK/img.png" data-phocus="https://blog.kakaocdn.net/dn/dr7wfl/dJMcafZ3AVt/kOiS8O8BSHAYfPTm1B77ZK/img.png"><img src="https://blog.kakaocdn.net/dn/dr7wfl/dJMcafZ3AVt/kOiS8O8BSHAYfPTm1B77ZK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fdr7wfl%2FdJMcafZ3AVt%2FkOiS8O8BSHAYfPTm1B77ZK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="531" height="292" data-origin-width="531" data-origin-height="292"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 심사자 교육훈련</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><a href="https://youtu.be/Rq0nsnJSAmk" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/Rq0nsnJSAmk</a></span></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=Rq0nsnJSAmk" data-video-thumbnail="https://scrap.kakaocdn.net/dn/HcshP/dJMb9fZt1V9/AgDukn6EWtbKDEAKdLRO9K/img.jpg?width=480&amp;height=360&amp;face=362_170_412_225,https://scrap.kakaocdn.net/dn/q41po/dJMb9hCZ0GU/c3NE9yUWt7avkQUHhlOyB0/img.jpg?width=480&amp;height=360&amp;face=362_170_412_225,https://scrap.kakaocdn.net/dn/bsT2Ns/dJMb9g49Sdc/VH1pFOJplKLbHQedZ565z1/img.jpg?width=480&amp;height=360&amp;face=362_170_412_225" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="식약처 심사관의 비밀 문서 공개?! 신약 허가의 '거대한 성벽'을 넘는 법 ️ (MaPP 5030.01G)" data-original-url=""><iframe src="https://www.youtube.com/embed/Rq0nsnJSAmk" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bKHwZ2/dJMcagLta0Z/Bub6fZbqaQ2lDPYxKhaK5k/%EB%B0%94%EC%9D%B4%EC%98%A4%EC%83%9D%EC%95%BD%EC%8B%AC%EC%82%AC%EB%B6%80%2B%EC%8B%AC%EC%82%AC%EC%9E%90%2B%EA%B5%90%EC%9C%A1%ED%9B%88%EB%A0%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">바이오생약심사부+심사자+교육훈련(공무원+지침서).pdf</span></div> <div class="size">0.30MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15234&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> </div> 품질보증(QA)/안내서_지침서 등 공무원지침서 바이오심사기준 바이오의약품 생약제제 식약처지침서 식품의약품안전평가원 역량강화 의약품심사관 전문교육훈련 제약바이오교육 빛별구 https://cnajini.tistory.com/577 https://cnajini.tistory.com/577#entry577comment Thu, 12 Mar 2026 11:53:04 +0900 https://cnajini.tistory.com/576 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 민원인 안내서 운영</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 바이오생약심사부 민원인 안내서 운영의 세부 지침을 정한것으로서&nbsp;식품의약품안전처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 민원인 안내서 운영</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="555" data-origin-height="761"><span data-url="https://blog.kakaocdn.net/dn/bhyaT3/dJMcacoKvUD/h0ile6ydX5OTSVUN2Q9Wzk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bhyaT3/dJMcacoKvUD/h0ile6ydX5OTSVUN2Q9Wzk/img.png"><img src="https://blog.kakaocdn.net/dn/bhyaT3/dJMcacoKvUD/h0ile6ydX5OTSVUN2Q9Wzk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbhyaT3%2FdJMcacoKvUD%2Fh0ile6ydX5OTSVUN2Q9Wzk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="555" height="761" data-origin-width="555" data-origin-height="761"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="542" data-origin-height="534"><span data-url="https://blog.kakaocdn.net/dn/cLF0q6/dJMcagSeiL3/n7bL6GQvumuiINIxLK9jy0/img.png" data-phocus="https://blog.kakaocdn.net/dn/cLF0q6/dJMcagSeiL3/n7bL6GQvumuiINIxLK9jy0/img.png"><img src="https://blog.kakaocdn.net/dn/cLF0q6/dJMcagSeiL3/n7bL6GQvumuiINIxLK9jy0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcLF0q6%2FdJMcagSeiL3%2Fn7bL6GQvumuiINIxLK9jy0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="542" height="534" data-origin-width="542" data-origin-height="534"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;<span style="background-color: #ffffff; color: #333333;">​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="530" data-origin-height="622"><span data-url="https://blog.kakaocdn.net/dn/dvXbPw/dJMb996DldY/ZNxa6krzsCmcgND5oigQs0/img.png" data-phocus="https://blog.kakaocdn.net/dn/dvXbPw/dJMb996DldY/ZNxa6krzsCmcgND5oigQs0/img.png"><img src="https://blog.kakaocdn.net/dn/dvXbPw/dJMb996DldY/ZNxa6krzsCmcgND5oigQs0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FdvXbPw%2FdJMb996DldY%2FZNxa6krzsCmcgND5oigQs0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="530" height="622" data-origin-width="530" data-origin-height="622"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 민원인 안내서 운영</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/mmRk64ZZWRE" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/mmRk64ZZWRE</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=mmRk64ZZWRE" data-video-thumbnail="https://scrap.kakaocdn.net/dn/J1HlX/dJMb9hC0dqp/kot4hCDH9Mo5FhFsxrXZ91/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/vHXZw/dJMb9jgv7wl/R8kI9yakYw6LjSUZPwBhKk/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/bGTwaB/dJMb9frEnAH/pycbOasXKrw8dWUITZ7RpK/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="식약처 비밀 창고 개방! 민원인 안내서에 이런 '치트키'가 숨겨져 있었다고? " data-original-url=""><iframe src="https://www.youtube.com/embed/mmRk64ZZWRE" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/b1bFdU/dJMcacoKvYy/jCRQyJ2D5PkFf9VM3PoePK/%EB%B0%94%EC%9D%B4%EC%98%A4%EC%83%9D%EC%95%BD%EC%8B%AC%EC%82%AC%EB%B6%80%2B%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%2B%EC%9A%B4%EC%98%81%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">바이오생약심사부+민원인+안내서+운영(공무원+지침서).pdf</span></div> <div class="size">1.06MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15233&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1773020660679" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="바이오생약심사부 민원인 안내서 운영 등록번호 지침서-0117-06 분야 모바일서비스 Y 고시일 2026-03-05 등록일 2026-03-06 조회수 94 첨부파일 첨부파일 전체 다운로드 --&gt; 바이오생약심사부 민원인 안" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15233&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15233&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15233&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15233&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">바이오생약심사부 민원인 안내서 운영 등록번호 지침서-0117-06 분야 모바일서비스 Y 고시일 2026-03-05 등록일 2026-03-06 조회수 94 첨부파일 첨부파일 전체 다운로드 --&gt; 바이오생약심사부 민원인 안</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 공무원지침서 민원인안내서 민원행정서비스 바이오생약심사부 바이오의약품심사 식약처가이드라인 식약처행정규칙 식품의약품안전평가원 의약품심사기준 제약바이오규제 빛별구 https://cnajini.tistory.com/576 https://cnajini.tistory.com/576#entry576comment Wed, 11 Mar 2026 11:45:05 +0900 https://cnajini.tistory.com/575 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 업무수행편람의 작성 및 운영</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 바이오생약심사부 업무수행편람의 작성 및 운영의 세부지침을 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 업무수행편람의 작성 및 운영</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="546" data-origin-height="726"><span data-url="https://blog.kakaocdn.net/dn/TAKOp/dJMcadHUQyh/C9YAHfTK9KDN1MqWPpGyTk/img.png" data-phocus="https://blog.kakaocdn.net/dn/TAKOp/dJMcadHUQyh/C9YAHfTK9KDN1MqWPpGyTk/img.png"><img src="https://blog.kakaocdn.net/dn/TAKOp/dJMcadHUQyh/C9YAHfTK9KDN1MqWPpGyTk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FTAKOp%2FdJMcadHUQyh%2FC9YAHfTK9KDN1MqWPpGyTk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="546" height="726" data-origin-width="546" data-origin-height="726"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span>​</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="509" data-origin-height="335"><span data-url="https://blog.kakaocdn.net/dn/bHDcqi/dJMcabchPjw/b3nIFht28mvX1TJMNqrAc1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bHDcqi/dJMcabchPjw/b3nIFht28mvX1TJMNqrAc1/img.png"><img src="https://blog.kakaocdn.net/dn/bHDcqi/dJMcabchPjw/b3nIFht28mvX1TJMNqrAc1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbHDcqi%2FdJMcabchPjw%2Fb3nIFht28mvX1TJMNqrAc1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="509" height="335" data-origin-width="509" data-origin-height="335"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="513"><span data-url="https://blog.kakaocdn.net/dn/uZBh3/dJMcabchPjB/WKM4MejkrkBwQ2RZhiQQRK/img.png" data-phocus="https://blog.kakaocdn.net/dn/uZBh3/dJMcabchPjB/WKM4MejkrkBwQ2RZhiQQRK/img.png"><img src="https://blog.kakaocdn.net/dn/uZBh3/dJMcabchPjB/WKM4MejkrkBwQ2RZhiQQRK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FuZBh3%2FdJMcabchPjB%2FWKM4MejkrkBwQ2RZhiQQRK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="513" data-origin-width="535" data-origin-height="513"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오생약심사부 업무수행편람</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/daetNw/dJMcaaqWqv4/06OueRK64V1r4iSd0a4cA1/%EB%B0%94%EC%9D%B4%EC%98%A4%EC%83%9D%EC%95%BD%EC%8B%AC%EC%82%AC%EB%B6%80%2B%EC%97%85%EB%AC%B4%EC%88%98%ED%96%89%ED%8E%B8%EB%9E%8C%EC%9D%98%2B%EC%9E%91%EC%84%B1%2B%EB%B0%8F%2B%EC%9A%B4%EC%98%81%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">바이오생약심사부+업무수행편람의+작성+및+운영(공무원+지침서).pdf</span></div> <div class="size">0.43MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15232&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/575 https://cnajini.tistory.com/575#entry575comment Tue, 10 Mar 2026 10:55:49 +0900 https://cnajini.tistory.com/574 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>2026년 시험검사기관 관리지침 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 식품&middot;의약품분야 시험&middot;검사기관 관리의 세부 지침을 정한 것으로서 식품의약품안전처&nbsp;내&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>2026년 시험검사기관 관리지침 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="581" data-origin-height="830"><span data-url="https://blog.kakaocdn.net/dn/bjDj5J/dJMcabchPcT/MatDl9d0z9QGHnFDuK4z40/img.png" data-phocus="https://blog.kakaocdn.net/dn/bjDj5J/dJMcabchPcT/MatDl9d0z9QGHnFDuK4z40/img.png"><img src="https://blog.kakaocdn.net/dn/bjDj5J/dJMcabchPcT/MatDl9d0z9QGHnFDuK4z40/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbjDj5J%2FdJMcabchPcT%2FMatDl9d0z9QGHnFDuK4z40%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="581" height="830" data-origin-width="581" data-origin-height="830"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span>​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="583" data-origin-height="599"><span data-url="https://blog.kakaocdn.net/dn/bCfzpl/dJMb99MiMjR/jfAiqtzm7wvryx2Bhdk6Q1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bCfzpl/dJMb99MiMjR/jfAiqtzm7wvryx2Bhdk6Q1/img.png"><img src="https://blog.kakaocdn.net/dn/bCfzpl/dJMb99MiMjR/jfAiqtzm7wvryx2Bhdk6Q1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbCfzpl%2FdJMb99MiMjR%2FjfAiqtzm7wvryx2Bhdk6Q1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="583" height="599" data-origin-width="583" data-origin-height="599"/></span></figure> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="590" data-origin-height="785"><span data-url="https://blog.kakaocdn.net/dn/c4XyQI/dJMcaaqWql0/scFI1yaMAeGjPIRXkc1hXK/img.png" data-phocus="https://blog.kakaocdn.net/dn/c4XyQI/dJMcaaqWql0/scFI1yaMAeGjPIRXkc1hXK/img.png"><img src="https://blog.kakaocdn.net/dn/c4XyQI/dJMcaaqWql0/scFI1yaMAeGjPIRXkc1hXK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fc4XyQI%2FdJMcaaqWql0%2FscFI1yaMAeGjPIRXkc1hXK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="590" height="785" data-origin-width="590" data-origin-height="785"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="543" data-origin-height="539"><span data-url="https://blog.kakaocdn.net/dn/QGSmt/dJMb996DjOQ/NyvGTEiD5GQg3hiVs2qnok/img.png" data-phocus="https://blog.kakaocdn.net/dn/QGSmt/dJMb996DjOQ/NyvGTEiD5GQg3hiVs2qnok/img.png"><img src="https://blog.kakaocdn.net/dn/QGSmt/dJMb996DjOQ/NyvGTEiD5GQg3hiVs2qnok/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FQGSmt%2FdJMb996DjOQ%2FNyvGTEiD5GQg3hiVs2qnok%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="543" height="539" data-origin-width="543" data-origin-height="539"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #ffffff; color: #333333; text-align: left;">시험검사기관 관리지침</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span><span style="background-color: #ffffff; color: #333333;"></span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/pKYME/dJMcajg3IB0/TB46ccgI3iyOrjwdciDLFk/2026%EB%85%84%2B%EC%8B%9C%ED%97%98%2B%EA%B2%80%EC%82%AC%EA%B8%B0%EA%B4%80%2B%EA%B4%80%EB%A6%AC%EC%A7%80%EC%B9%A8.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">2026년+시험+검사기관+관리지침.pdf</span></div> <div class="size">6.94MB</div> </div> </a></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15231&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/574 https://cnajini.tistory.com/574#entry574comment Mon, 9 Mar 2026 09:51:38 +0900 https://cnajini.tistory.com/573 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>2025년 의약품 안전성 정보 종합보고서」 발간&middot;배포 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 사항을 식품의약품안전처의 입장을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="509" data-origin-height="146"><span data-url="https://blog.kakaocdn.net/dn/rMm5a/dJMcac3g7Ot/I31U1bJn36JybTfpuBxkK1/img.png" data-phocus="https://blog.kakaocdn.net/dn/rMm5a/dJMcac3g7Ot/I31U1bJn36JybTfpuBxkK1/img.png"><img src="https://blog.kakaocdn.net/dn/rMm5a/dJMcac3g7Ot/I31U1bJn36JybTfpuBxkK1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FrMm5a%2FdJMcac3g7Ot%2FI31U1bJn36JybTfpuBxkK1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="509" height="146" data-origin-width="509" data-origin-height="146"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>2025년 의약품 안전성 정보 종합보고서」 발간&middot;배포 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 03월 03일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="572" data-origin-height="798"><span data-url="https://blog.kakaocdn.net/dn/bf1k5M/dJMcab4n56Y/LqX563BkzzOkQT8Uqdb9Rk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bf1k5M/dJMcab4n56Y/LqX563BkzzOkQT8Uqdb9Rk/img.png"><img src="https://blog.kakaocdn.net/dn/bf1k5M/dJMcab4n56Y/LqX563BkzzOkQT8Uqdb9Rk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbf1k5M%2FdJMcab4n56Y%2FLqX563BkzzOkQT8Uqdb9Rk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="572" height="798" data-origin-width="572" data-origin-height="798"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span><span>​</span><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="481" data-origin-height="719"><span data-url="https://blog.kakaocdn.net/dn/bJO4C7/dJMcad19QoJ/MjIfmY3TuP8Q3yWA5BdjR0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bJO4C7/dJMcad19QoJ/MjIfmY3TuP8Q3yWA5BdjR0/img.png"><img src="https://blog.kakaocdn.net/dn/bJO4C7/dJMcad19QoJ/MjIfmY3TuP8Q3yWA5BdjR0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbJO4C7%2FdJMcad19QoJ%2FMjIfmY3TuP8Q3yWA5BdjR0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="481" height="719" data-origin-width="481" data-origin-height="719"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #000000; text-align: left;">의약품 안전성 정보</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/G8jwB/dJMcacoHnw5/P6Uxz1aUF7JTpVoUUp9oG1/%E3%80%8C2025%EB%85%84_%EC%9D%98%EC%95%BD%ED%92%88_%EC%95%88%EC%A0%84%EC%84%B1_%EC%A0%95%EB%B3%B4_%EC%A2%85%ED%95%A9%EB%B3%B4%EA%B3%A0%EC%84%9C%E3%80%8D_%28%EC%A0%9C5%ED%98%B8%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">「2025년_의약품_안전성_정보_종합보고서」_(제5호).pdf</span></div> <div class="size">5.85MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/law/policy/select/210733?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">입법/행정 &middot; 한국제약바이오협회</a></p> <figure id="og_1772587670074" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/law/policy/select/210733?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/bPdXTs/dJMb8U8Rhnx/RvJBJsn6sS7DxhQT1HZR0k/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/berRrq/dJMb9fZsXTM/j6gVhVKO0rGD1Mgpf6R5d1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/rmDby/dJMb84p6mJQ/DTBYN3uwvusYiriHJ8T2m1/img.png?width=765&amp;height=640&amp;face=0_0_765_640"><a href="https://www.kpbma.or.kr/info/law/policy/select/210733?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/law/policy/select/210733?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/bPdXTs/dJMb8U8Rhnx/RvJBJsn6sS7DxhQT1HZR0k/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/berRrq/dJMb9fZsXTM/j6gVhVKO0rGD1Mgpf6R5d1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/rmDby/dJMb84p6mJQ/DTBYN3uwvusYiriHJ8T2m1/img.png?width=765&amp;height=640&amp;face=0_0_765_640');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/573 https://cnajini.tistory.com/573#entry573comment Wed, 4 Mar 2026 10:28:05 +0900 https://cnajini.tistory.com/572 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상 가이드라인 해설서</span> </span>자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 「임상시험 대상자 동의&middot;설명서 및 피해보상 가이드라인 (민원인 안내서)」에 대한 이해를 돕기 위해 알기 쉽게 설명하거나 식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상 가이드라인 해설서</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 27일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="539" data-origin-height="759"><span data-url="https://blog.kakaocdn.net/dn/oOWYx/dJMcabJ6Y7L/kZ4klSNM5wViPpOWdOJ5n0/img.png" data-phocus="https://blog.kakaocdn.net/dn/oOWYx/dJMcabJ6Y7L/kZ4klSNM5wViPpOWdOJ5n0/img.png"><img src="https://blog.kakaocdn.net/dn/oOWYx/dJMcabJ6Y7L/kZ4klSNM5wViPpOWdOJ5n0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FoOWYx%2FdJMcabJ6Y7L%2FkZ4klSNM5wViPpOWdOJ5n0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="539" height="759" data-origin-width="539" data-origin-height="759"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span><span style="letter-spacing: 0px;">​</span></p> </div> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="538" data-origin-height="303"><span data-url="https://blog.kakaocdn.net/dn/b2kDfB/dJMcajgZUDh/lu45kd2OvFK96Jt4ZDttOK/img.png" data-phocus="https://blog.kakaocdn.net/dn/b2kDfB/dJMcajgZUDh/lu45kd2OvFK96Jt4ZDttOK/img.png"><img src="https://blog.kakaocdn.net/dn/b2kDfB/dJMcajgZUDh/lu45kd2OvFK96Jt4ZDttOK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fb2kDfB%2FdJMcajgZUDh%2Flu45kd2OvFK96Jt4ZDttOK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="538" height="303" data-origin-width="538" data-origin-height="303"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="542" data-origin-height="749"><span data-url="https://blog.kakaocdn.net/dn/2DwRZ/dJMcacPLuyF/3FTkzs7m8LeC5KWKy9ci50/img.png" data-phocus="https://blog.kakaocdn.net/dn/2DwRZ/dJMcacPLuyF/3FTkzs7m8LeC5KWKy9ci50/img.png"><img src="https://blog.kakaocdn.net/dn/2DwRZ/dJMcacPLuyF/3FTkzs7m8LeC5KWKy9ci50/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F2DwRZ%2FdJMcacPLuyF%2F3FTkzs7m8LeC5KWKy9ci50%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="542" height="749" data-origin-width="542" data-origin-height="749"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상<span>&nbsp;</span></span></span></span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><a href="https://youtu.be/NDFV1SRZg0o?si=VDa4dKymF0zSnWJl" target="_blank" rel="noopener&nbsp;noreferrer">https://youtu.be/NDFV1SRZg0o?si=VDa4dKymF0zSnWJl</a></p> <figure data-ke-type="video" data-ke-style="alignCenter" data-video-host="youtube" data-video-url="https://www.youtube.com/watch?v=NDFV1SRZg0o" data-video-thumbnail="https://scrap.kakaocdn.net/dn/stwWV/dJMb9g49MMb/2gY3noWkvdHaLBBWYEdavK/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/eQwmSc/dJMb9frD5I0/TX6gu1ogTPPtfmEFq2Cjw0/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360,https://scrap.kakaocdn.net/dn/dLAw4a/dJMb9eTOiZw/IQHWGpkWvh5VudkOBKTzW0/img.jpg?width=480&amp;height=360&amp;face=0_0_480_360" data-video-width="480" data-video-height="360" data-video-origin-width="480" data-video-origin-height="360" data-ke-mobilestyle="widthContent" data-video-title="임상시험 싸인하기 전 &lsquo;이것&rsquo; 모르면 평생 후회합니다 보상 범위부터 중단 권리까지 총정" data-original-url=""><iframe src="https://www.youtube.com/embed/NDFV1SRZg0o" width="480" height="360" frameborder="" allowfullscreen="true"></iframe> <figcaption style="display: none;"></figcaption> </figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/zR9oB/dJMcaivDzGN/ZOb1oqLLiGkkttiCKp04KK/%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%2B%EB%8C%80%EC%83%81%EC%9E%90%2B%EB%8F%99%EC%9D%98%EC%84%A4%EB%AA%85%EC%84%9C%2B%EB%B0%8F%2B%ED%94%BC%ED%95%B4%EB%B3%B4%EC%83%81%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%2B%ED%95%B4%EC%84%A4%EC%84%9C%2B%28%EB%AF%BC%EC%9B%90%EC%9D%B8%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">임상시험+대상자+동의설명서+및+피해보상+가이드라인+해설서+(민원인안내서).pdf</span></div> <div class="size">0.84MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15825&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1772499212977" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="임상시험 대상자 동의설명서 및 피해보상 가이드라인 해설서 식품의약품안전처(임상정책과)에서는 '임상시험 대상자 동의설명서 및 피해보상 가이드라인'의 항목별 구체적인 해설 및 FAQ 등을 " data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15825&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15825&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15825&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15825&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">임상시험 대상자 동의설명서 및 피해보상 가이드라인 해설서 식품의약품안전처(임상정책과)에서는 '임상시험 대상자 동의설명서 및 피해보상 가이드라인'의 항목별 구체적인 해설 및 FAQ 등을</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/572 https://cnajini.tistory.com/572#entry572comment Tue, 3 Mar 2026 09:53:47 +0900 https://cnajini.tistory.com/571 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 임상시험 대상자 동의&middot;설명서 작성 및 피해자 보상에 대한 규약과 절차 마련을 위해 고려되어야 할 사항 등을 설명하거나 식품의약품안전처의 입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 27일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="763"><span data-url="https://blog.kakaocdn.net/dn/kX8YE/dJMcadVmyQm/THH7Zfo9wF6ORJKFU3qVrK/img.png" data-phocus="https://blog.kakaocdn.net/dn/kX8YE/dJMcadVmyQm/THH7Zfo9wF6ORJKFU3qVrK/img.png"><img src="https://blog.kakaocdn.net/dn/kX8YE/dJMcadVmyQm/THH7Zfo9wF6ORJKFU3qVrK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FkX8YE%2FdJMcadVmyQm%2FTHH7Zfo9wF6ORJKFU3qVrK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="763" data-origin-width="535" data-origin-height="763"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="427"><span data-url="https://blog.kakaocdn.net/dn/bXmCCa/dJMcadVmyRA/pqofMfyxIyGPFdzhXB9Ta0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bXmCCa/dJMcadVmyRA/pqofMfyxIyGPFdzhXB9Ta0/img.png"><img src="https://blog.kakaocdn.net/dn/bXmCCa/dJMcadVmyRA/pqofMfyxIyGPFdzhXB9Ta0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbXmCCa%2FdJMcadVmyRA%2FpqofMfyxIyGPFdzhXB9Ta0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="427" data-origin-width="535" data-origin-height="427"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="746"><span data-url="https://blog.kakaocdn.net/dn/bZw8oN/dJMcahjeBBG/zz6LiLakjMXDxbDG9sPVwK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bZw8oN/dJMcahjeBBG/zz6LiLakjMXDxbDG9sPVwK/img.png"><img src="https://blog.kakaocdn.net/dn/bZw8oN/dJMcahjeBBG/zz6LiLakjMXDxbDG9sPVwK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbZw8oN%2FdJMcahjeBBG%2Fzz6LiLakjMXDxbDG9sPVwK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="746" data-origin-width="535" data-origin-height="746"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;">임 <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험 대상자 동의설명서 및 피해보상 </span></span></span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/Ca0St/dJMb996xZ7z/XrKy08CQni79wKUpBKt87K/%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%2B%EB%8C%80%EC%83%81%EC%9E%90%2B%EB%8F%99%EC%9D%98%EC%84%A4%EB%AA%85%EC%84%9C%2B%EB%B0%8F%2B%ED%94%BC%ED%95%B4%EB%B3%B4%EC%83%81%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%2B%28%EB%AF%BC%EC%9B%90%EC%9D%B8%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">임상시험+대상자+동의설명서+및+피해보상+가이드라인+(민원인안내서).pdf</span></div> <div class="size">1.00MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15824&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1772150652026" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="임상시험 대상자 동의설명서 및 피해보상 가이드라인 등록번호 안내서-0052-04 분야 의약품 고시일 2026-02-27 등록일 2026-02-27 조회수 21 식품의약품안전처(임상정책과)에서는 임상시험대상자 동의." data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15824&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15824&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15824&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15824&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">임상시험 대상자 동의설명서 및 피해보상 가이드라인 등록번호 안내서-0052-04 분야 의약품 고시일 2026-02-27 등록일 2026-02-27 조회수 21 식품의약품안전처(임상정책과)에서는 임상시험대상자 동의.</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/571 https://cnajini.tistory.com/571#entry571comment Fri, 27 Feb 2026 09:04:28 +0900 https://cnajini.tistory.com/570 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 임상시험용의약품 치료목적사용 관련 비용청구 시, 임상시험용의약품 원가에 해당하는 세부항목에 대하여 알기 쉽게 설명하기 위해&nbsp;관련&nbsp;내용을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「 <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 26일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="530" data-origin-height="738"><span data-url="https://blog.kakaocdn.net/dn/bPWX2t/dJMcaiCnIKX/SonG67UueEoIn1RsJVzC51/img.png" data-phocus="https://blog.kakaocdn.net/dn/bPWX2t/dJMcaiCnIKX/SonG67UueEoIn1RsJVzC51/img.png"><img src="https://blog.kakaocdn.net/dn/bPWX2t/dJMcaiCnIKX/SonG67UueEoIn1RsJVzC51/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbPWX2t%2FdJMcaiCnIKX%2FSonG67UueEoIn1RsJVzC51%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="530" height="738" data-origin-width="530" data-origin-height="738"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="554" data-origin-height="428"><span data-url="https://blog.kakaocdn.net/dn/rWuq8/dJMcagYSJBc/UpsZmju2350mY1KiV0VEWK/img.png" data-phocus="https://blog.kakaocdn.net/dn/rWuq8/dJMcagYSJBc/UpsZmju2350mY1KiV0VEWK/img.png"><img src="https://blog.kakaocdn.net/dn/rWuq8/dJMcagYSJBc/UpsZmju2350mY1KiV0VEWK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FrWuq8%2FdJMcagYSJBc%2FUpsZmju2350mY1KiV0VEWK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="554" height="428" data-origin-width="554" data-origin-height="428"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="562" data-origin-height="707"><span data-url="https://blog.kakaocdn.net/dn/kzgaH/dJMcag5FH8L/g6N1dROcp4cSjvS0dmKKo1/img.png" data-phocus="https://blog.kakaocdn.net/dn/kzgaH/dJMcag5FH8L/g6N1dROcp4cSjvS0dmKKo1/img.png"><img src="https://blog.kakaocdn.net/dn/kzgaH/dJMcag5FH8L/g6N1dROcp4cSjvS0dmKKo1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FkzgaH%2FdJMcag5FH8L%2Fg6N1dROcp4cSjvS0dmKKo1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="562" height="707" data-origin-width="562" data-origin-height="707"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">임상시험용의약품 치료목적사용 비용청구</span>&nbsp;</span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bdgt1R/dJMcahDtGQX/25QQntgiYmLrkFdhHy7s31/%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%EC%9A%A9%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%B9%98%EB%A3%8C%EB%AA%A9%EC%A0%81%EC%82%AC%EC%9A%A9%2B%EB%B9%84%EC%9A%A9%EC%B2%AD%EA%B5%AC%2B%EA%B4%80%EB%A0%A8%2B%EC%9B%90%EA%B0%80%2B%EC%84%B8%EB%B6%80%ED%95%AD%EB%AA%A9%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">임상시험용의약품+치료목적사용+비용청구+관련+원가+세부항목+가이드라인.pdf</span></div> <div class="size">0.31MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15823&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1772078995074" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 가이드라인 임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 등을 안내하는 「임상시험용의약품 치료목적사용 비" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15823&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15823&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15823&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15823&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 가이드라인 임상시험용의약품 치료목적사용 비용청구 관련 원가 세부항목 등을 안내하는 「임상시험용의약품 치료목적사용 비</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/570 https://cnajini.tistory.com/570#entry570comment Thu, 26 Feb 2026 13:10:13 +0900 https://cnajini.tistory.com/569 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>[생물의약품] 크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="544" data-origin-height="133"><span data-url="https://blog.kakaocdn.net/dn/dndcFw/dJMcajaawI8/R4kfNN1o8GFiGlS5wxVzJ0/img.png" data-phocus="https://blog.kakaocdn.net/dn/dndcFw/dJMcajaawI8/R4kfNN1o8GFiGlS5wxVzJ0/img.png"><img src="https://blog.kakaocdn.net/dn/dndcFw/dJMcajaawI8/R4kfNN1o8GFiGlS5wxVzJ0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FdndcFw%2FdJMcajaawI8%2FR4kfNN1o8GFiGlS5wxVzJ0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="749" height="183" data-origin-width="544" data-origin-height="133"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「[생물의약품] 크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 20일' 자로 식품의약품안전평가원의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="616" data-origin-height="822"><span data-url="https://blog.kakaocdn.net/dn/rTEjN/dJMcahXLIkn/UlIJM4n3Jjz7OgqdbvClB0/img.png" data-phocus="https://blog.kakaocdn.net/dn/rTEjN/dJMcahXLIkn/UlIJM4n3Jjz7OgqdbvClB0/img.png"><img src="https://blog.kakaocdn.net/dn/rTEjN/dJMcahXLIkn/UlIJM4n3Jjz7OgqdbvClB0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FrTEjN%2FdJMcahXLIkn%2FUlIJM4n3Jjz7OgqdbvClB0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="616" height="822" data-origin-width="616" data-origin-height="822"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="512" data-origin-height="758"><span data-url="https://blog.kakaocdn.net/dn/bDemye/dJMcafMrscO/XjjokJidqLPa03KDX0Hzh0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bDemye/dJMcafMrscO/XjjokJidqLPa03KDX0Hzh0/img.png"><img src="https://blog.kakaocdn.net/dn/bDemye/dJMcafMrscO/XjjokJidqLPa03KDX0Hzh0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbDemye%2FdJMcafMrscO%2FXjjokJidqLPa03KDX0Hzh0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="512" height="758" data-origin-width="512" data-origin-height="758"/></span></figure> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="485" data-origin-height="511"><span data-url="https://blog.kakaocdn.net/dn/dAmIRh/dJMcagYQLMW/QnAziNZSwDm9RJUEVnml51/img.png" data-phocus="https://blog.kakaocdn.net/dn/dAmIRh/dJMcagYQLMW/QnAziNZSwDm9RJUEVnml51/img.png"><img src="https://blog.kakaocdn.net/dn/dAmIRh/dJMcagYQLMW/QnAziNZSwDm9RJUEVnml51/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FdAmIRh%2FdJMcagYQLMW%2FQnAziNZSwDm9RJUEVnml51%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="485" height="511" data-origin-width="485" data-origin-height="511"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #000000; text-align: left;">[생물의약품] 크리스퍼 기반 유전자 편집 기술 및 치료제 개발</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">다음의 첨부파일은 분할압축된 것으로 전체 다운로드하여 압축을 풀면 됩니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/dgg7re/dJMcafeCpto/9z5Ivlq22aksFK9cJ54ZW0/%ED%81%AC%EB%A6%AC%EC%8A%A4%ED%8D%BC%2B%EA%B8%B0%EB%B0%98%2B%EC%9C%A0%EC%A0%84%EC%9E%90%2B%ED%8E%B8%EC%A7%91%2B%EA%B8%B0%EC%88%A0%2B%EB%B0%8F%2B%EC%B9%98%EB%A3%8C%EC%A0%9C%2B%EA%B0%9C%EB%B0%9C%2B%EB%8F%99%ED%96%A5%2B%EC%A0%95%EB%B3%B4%EC%A7%91.zip?attach=1&amp;knm=tfile.zip" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">크리스퍼+기반+유전자+편집+기술+및+치료제+개발+동향+정보집.zip</span></div> <div class="size">4.53MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/blBzv5/dJMcai3nYrY/QuYqEnWov6X4fqupZF5GNk/%ED%81%AC%EB%A6%AC%EC%8A%A4%ED%8D%BC%2B%EA%B8%B0%EB%B0%98%2B%EC%9C%A0%EC%A0%84%EC%9E%90%2B%ED%8E%B8%EC%A7%91%2B%EA%B8%B0%EC%88%A0%2B%EB%B0%8F%2B%EC%B9%98%EB%A3%8C%EC%A0%9C%2B%EA%B0%9C%EB%B0%9C%2B%EB%8F%99%ED%96%A5%2B%EC%A0%95%EB%B3%B4%EC%A7%91.z01?attach=1&amp;knm=tfile.z01" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">크리스퍼+기반+유전자+편집+기술+및+치료제+개발+동향+정보집.z01</span></div> <div class="size">19.53MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12866">정보마당 &gt; 간행물&middot;자료집 &gt; 크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집 | 식품의약품안전평가원</a></p> <figure id="og_1771891503222" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="정보마당 &gt; 간행물&middot;자료집 &gt; 크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집 | 식품" data-og-description="첨단바이오융복합연구과 주관의 용역연구개발과제 수행을 통해 '크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집'을 발간하였습니다. 관련 분야 연구 개발자와 심사 관련 종사자에" data-og-host="www.nifds.go.kr" data-og-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12866" data-og-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12866" data-og-image=""><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12866" target="_blank" rel="noopener" data-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12866"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">정보마당 &gt; 간행물&middot;자료집 &gt; 크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집 | 식품</p> <p class="og-desc" data-ke-size="size16">첨단바이오융복합연구과 주관의 용역연구개발과제 수행을 통해 '크리스퍼 기반 유전자 편집 기술 및 치료제 개발 동향 정보집'을 발간하였습니다. 관련 분야 연구 개발자와 심사 관련 종사자에</p> <p class="og-host" data-ke-size="size16">www.nifds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/569 https://cnajini.tistory.com/569#entry569comment Tue, 24 Feb 2026 09:05:19 +0900 https://cnajini.tistory.com/568 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>「외부 대조군 임상시험의 설계 및 수행 시 고려 사항」(민원인 안내서) 제정 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 완제 의약품의 외부 대조군 임상시험 설계 및 수행 고려 사항에 대하여&nbsp;알기&nbsp;쉽게&nbsp;설명하거나&nbsp;식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「외부 대조군 임상시험의 설계 및 수행 시 고려 사항」(민원인 안내서) 제정 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 13일' 자로 한국의약품수출입협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="545" data-origin-height="786"><span data-url="https://blog.kakaocdn.net/dn/nLRwY/dJMcagxHpMI/GEGVkzx8vyLE7RKPgrKqLk/img.png" data-phocus="https://blog.kakaocdn.net/dn/nLRwY/dJMcagxHpMI/GEGVkzx8vyLE7RKPgrKqLk/img.png"><img src="https://blog.kakaocdn.net/dn/nLRwY/dJMcagxHpMI/GEGVkzx8vyLE7RKPgrKqLk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FnLRwY%2FdJMcagxHpMI%2FGEGVkzx8vyLE7RKPgrKqLk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="545" height="786" data-origin-width="545" data-origin-height="786"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="518" data-origin-height="220"><span data-url="https://blog.kakaocdn.net/dn/bdbfFV/dJMcafMm5jd/4PMcwDy8A2HdO32yCSVKKk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bdbfFV/dJMcafMm5jd/4PMcwDy8A2HdO32yCSVKKk/img.png"><img src="https://blog.kakaocdn.net/dn/bdbfFV/dJMcafMm5jd/4PMcwDy8A2HdO32yCSVKKk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbdbfFV%2FdJMcafMm5jd%2F4PMcwDy8A2HdO32yCSVKKk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="518" height="220" data-origin-width="518" data-origin-height="220"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="547" data-origin-height="743"><span data-url="https://blog.kakaocdn.net/dn/cW3zVq/dJMcaihZBx3/KYyYY6ON6W71L6KzGPqTD1/img.png" data-phocus="https://blog.kakaocdn.net/dn/cW3zVq/dJMcaihZBx3/KYyYY6ON6W71L6KzGPqTD1/img.png"><img src="https://blog.kakaocdn.net/dn/cW3zVq/dJMcaihZBx3/KYyYY6ON6W71L6KzGPqTD1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcW3zVq%2FdJMcaihZBx3%2FKYyYY6ON6W71L6KzGPqTD1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="547" height="743" data-origin-width="547" data-origin-height="743"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #000000; text-align: left;">외부 대조군 임상시험의 설계 및 수행</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/eGaV6e/dJMcaiI18UZ/mdM3NheNhbEvQEZ0Uhlx31/%EC%99%B8%EB%B6%80%20%EB%8C%80%EC%A1%B0%EA%B5%B0%20%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%EC%9D%98%20%EC%84%A4%EA%B3%84%20%EB%B0%8F%20%EC%88%98%ED%96%89%20%EC%8B%9C%20%EA%B3%A0%EB%A0%A4%20%EC%82%AC%ED%95%AD%28%EB%AF%BC%EC%9B%90%EC%9D%B8%20%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">외부 대조군 임상시험의 설계 및 수행 시 고려 사항(민원인 안내서).pdf</span></div> <div class="size">0.36MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpta.or.kr/importP/pharmaceutical_officialDoc_view">한국의약품수출입협회</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/568 https://cnajini.tistory.com/568#entry568comment Thu, 19 Feb 2026 10:51:49 +0900 https://cnajini.tistory.com/567 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혁신제품 사전상담 리플릿(개정판) 발간 알림</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 <span style="background-color: #ffffff; color: #333333; text-align: start;">식품&middot;의약품&middot;의료기기 등의 신속한 제품화를 위한 '혁신제품 사전상담'제도를 안내하는 </span>것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혁신제품 사전상담 리플릿(개정판) 발간 알림</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 11일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="841" data-origin-height="596"><span data-url="https://blog.kakaocdn.net/dn/1qOqX/dJMcag5v9qN/jmK9XoNF4dRii4Cqnfgxr0/img.png" data-phocus="https://blog.kakaocdn.net/dn/1qOqX/dJMcag5v9qN/jmK9XoNF4dRii4Cqnfgxr0/img.png"><img src="https://blog.kakaocdn.net/dn/1qOqX/dJMcag5v9qN/jmK9XoNF4dRii4Cqnfgxr0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F1qOqX%2FdJMcag5v9qN%2FjmK9XoNF4dRii4Cqnfgxr0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="841" height="596" data-origin-width="841" data-origin-height="596"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;">&nbsp;</div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​ <span style="background-color: #f8f8f8; color: #333333; text-align: start;">혁신제품 사전상담</span> </span><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/KFkXA/dJMcafeuJPw/N2u4rhJUHgfmYDKFnUsen0/26%EB%85%84%2B%ED%98%81%EC%8B%A0%EC%A0%9C%ED%92%88%2B%EC%82%AC%EC%A0%84%EC%83%81%EB%8B%B4%2B%EB%A6%AC%ED%94%8C%EB%A0%9B%2B%28%EA%B2%8C%EC%8B%9C%EC%9A%A9%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">26년+혁신제품+사전상담+리플렛+(게시용).pdf</span></div> <div class="size">4.71MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_227/view.do?seq=33390&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;홍보물자료&gt;일반홍보물 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1770871534209" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;홍보물자료&gt;일반홍보물 | 식품의약품안전처" data-og-description="혁신제품 사전상담 리플릿(개정판) 발간 알림 분야 등록일 2026-02-11 조회수 53 첨부파일 첨부파일 전체 다운로드 --&gt; 26년 혁신제품 사전상담 리플렛 (게시용).pdf 다운받기 미리보기 첨부파일 보기 " data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_227/view.do?seq=33390&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_227/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=33390&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_227/view.do?seq=33390&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_227/view.do?seq=33390&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;홍보물자료&gt;일반홍보물 | 식품의약품안전처</p> <p class="og-desc" data-ke-size="size16">혁신제품 사전상담 리플릿(개정판) 발간 알림 분야 등록일 2026-02-11 조회수 53 첨부파일 첨부파일 전체 다운로드 --&gt; 26년 혁신제품 사전상담 리플렛 (게시용).pdf 다운받기 미리보기 첨부파일 보기</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/567 https://cnajini.tistory.com/567#entry567comment Fri, 13 Feb 2026 14:45:50 +0900 https://cnajini.tistory.com/566 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>「외부&nbsp;대조군&nbsp;임상시험의&nbsp;설계&nbsp;및&nbsp;수행&nbsp;시&nbsp;고려&nbsp;사항」(민원인&nbsp;안내서)&nbsp;제정&nbsp;알림자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 완제 의약품의 외부 대조군 임상시험 설계 및 수행 고려 사항에 대하여&nbsp;알기&nbsp;쉽게&nbsp;설명하거나&nbsp;식품의약품안전처의&nbsp;입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「외부&nbsp;대조군&nbsp;임상시험의&nbsp;설계&nbsp;및&nbsp;수행&nbsp;시&nbsp;고려&nbsp;사항」(민원인&nbsp;안내서)&nbsp;제정&nbsp;알림자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 11일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="527" data-origin-height="740"><span data-url="https://blog.kakaocdn.net/dn/bdPD54/dJMcabpCr6d/Cr6yJWsOMkWKUSyUHZC3UK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bdPD54/dJMcabpCr6d/Cr6yJWsOMkWKUSyUHZC3UK/img.png"><img src="https://blog.kakaocdn.net/dn/bdPD54/dJMcabpCr6d/Cr6yJWsOMkWKUSyUHZC3UK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbdPD54%2FdJMcabpCr6d%2FCr6yJWsOMkWKUSyUHZC3UK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="527" height="740" data-origin-width="527" data-origin-height="740"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="541" data-origin-height="213"><span data-url="https://blog.kakaocdn.net/dn/c4gZzE/dJMcag5v9eh/3CT2yBjdyWaGgq8QB6m460/img.png" data-phocus="https://blog.kakaocdn.net/dn/c4gZzE/dJMcag5v9eh/3CT2yBjdyWaGgq8QB6m460/img.png"><img src="https://blog.kakaocdn.net/dn/c4gZzE/dJMcag5v9eh/3CT2yBjdyWaGgq8QB6m460/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fc4gZzE%2FdJMcag5v9eh%2F3CT2yBjdyWaGgq8QB6m460%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="541" height="213" data-origin-width="541" data-origin-height="213"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="543" data-origin-height="751"><span data-url="https://blog.kakaocdn.net/dn/b6pOcH/dJMcafldSyL/llss5b7fEm550gZlhBsP61/img.png" data-phocus="https://blog.kakaocdn.net/dn/b6pOcH/dJMcafldSyL/llss5b7fEm550gZlhBsP61/img.png"><img src="https://blog.kakaocdn.net/dn/b6pOcH/dJMcafldSyL/llss5b7fEm550gZlhBsP61/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fb6pOcH%2FdJMcafldSyL%2Fllss5b7fEm550gZlhBsP61%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="543" height="751" data-origin-width="543" data-origin-height="751"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;">외부 대조군 임상시험의 설계 및 수행 시</span> </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/n6Fsw/dJMcacvh6KQ/NZG1gJmWvgC3hdQ7L7Dx91/%EB%B6%99%EC%9E%84._%EC%99%B8%EB%B6%80_%EB%8C%80%EC%A1%B0%EA%B5%B0_%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%EC%9D%98_%EC%84%A4%EA%B3%84_%EB%B0%8F_%EC%88%98%ED%96%89_%EC%8B%9C_%EA%B3%A0%EB%A0%A4_%EC%82%AC%ED%95%AD%28%EB%AF%BC%EC%9B%90%EC%9D%B8_%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">붙임._외부_대조군_임상시험의_설계_및_수행_시_고려_사항(민원인_안내서).pdf</span></div> <div class="size">0.36MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/law/statute/select/210710?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">입법/행정 &middot; 한국제약바이오협회</a></p> <figure id="og_1770871117201" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/law/statute/select/210710?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/bWLaCJ/dJMb8Zvxsaf/zkoLkGtFUQUxtWtuSQSUak/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/eTVPm/dJMb8864U3j/ztdsoZHPXVK4WozTHWY5PK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/BFx5o/dJMb82My5xI/ssxKOAMXc1AUx4GoYCFUnk/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080"><a href="https://www.kpbma.or.kr/info/law/statute/select/210710?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/law/statute/select/210710?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/bWLaCJ/dJMb8Zvxsaf/zkoLkGtFUQUxtWtuSQSUak/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/eTVPm/dJMb8864U3j/ztdsoZHPXVK4WozTHWY5PK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/BFx5o/dJMb82My5xI/ssxKOAMXc1AUx4GoYCFUnk/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/566 https://cnajini.tistory.com/566#entry566comment Thu, 12 Feb 2026 13:38:54 +0900 https://cnajini.tistory.com/565 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 1월(하))」 배포 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1307" data-origin-height="199"><span data-url="https://blog.kakaocdn.net/dn/48b42/dJMcagEroTA/OLaS14Au9rcj3ZOqKKwbok/img.png" data-phocus="https://blog.kakaocdn.net/dn/48b42/dJMcagEroTA/OLaS14Au9rcj3ZOqKKwbok/img.png"><img src="https://blog.kakaocdn.net/dn/48b42/dJMcagEroTA/OLaS14Au9rcj3ZOqKKwbok/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F48b42%2FdJMcagEroTA%2FOLaS14Au9rcj3ZOqKKwbok%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1307" height="199" data-origin-width="1307" data-origin-height="199"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 1월(하))」 배포 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 06일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="550" data-origin-height="790"><span data-url="https://blog.kakaocdn.net/dn/B31BF/dJMcabwkvwM/FoxyOa3HMFbzsewGAXOec0/img.png" data-phocus="https://blog.kakaocdn.net/dn/B31BF/dJMcabwkvwM/FoxyOa3HMFbzsewGAXOec0/img.png"><img src="https://blog.kakaocdn.net/dn/B31BF/dJMcabwkvwM/FoxyOa3HMFbzsewGAXOec0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FB31BF%2FdJMcabwkvwM%2FFoxyOa3HMFbzsewGAXOec0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="550" height="790" data-origin-width="550" data-origin-height="790"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="495" data-origin-height="721"><span data-url="https://blog.kakaocdn.net/dn/cgYeiS/dJMcaac8Shu/OK187zOheYknkuN5e3omtK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cgYeiS/dJMcaac8Shu/OK187zOheYknkuN5e3omtK/img.png"><img src="https://blog.kakaocdn.net/dn/cgYeiS/dJMcaac8Shu/OK187zOheYknkuN5e3omtK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcgYeiS%2FdJMcaac8Shu%2FOK187zOheYknkuN5e3omtK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="495" height="721" data-origin-width="495" data-origin-height="721"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>의료제품 분야 최신 해외 동향 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bMGOd0/dJMcabJTYD4/otYzrhSpKY3LrYaK7tKQHK/%EC%9D%98%EB%A3%8C%EC%A0%9C%ED%92%88_%EB%B6%84%EC%95%BC%2C_%EC%B5%9C%EC%8B%A0_%ED%95%B4%EC%99%B8_%EB%8F%99%ED%96%A5_%EC%A0%95%EB%B3%B4%EC%A7%80%282026%EB%85%84_1%EC%9B%94%28%ED%95%98%29%29.zip?attach=1&amp;knm=tfile.zip" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의료제품_분야,_최신_해외_동향_정보지(2026년_1월(하)).zip</span></div> <div class="size">1.76MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248786?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">공지사항 &middot; 한국제약바이오협회</a></p> <figure id="og_1770696787159" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248786?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/kN6lx/dJMb9cBDXaH/noRlCZu9Jb4HKHKPQChYzk/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/zVKGr/dJMb8SXtDAV/rvIWsYtpGD0iJMzsfiVub0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b1FJnz/dJMb9kTYNCN/LIqKM2BPU6ZvCZ2KyQmJXk/img.png?width=765&amp;height=640&amp;face=0_0_765_640"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248786?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248786?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/kN6lx/dJMb9cBDXaH/noRlCZu9Jb4HKHKPQChYzk/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/zVKGr/dJMb8SXtDAV/rvIWsYtpGD0iJMzsfiVub0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b1FJnz/dJMb9kTYNCN/LIqKM2BPU6ZvCZ2KyQmJXk/img.png?width=765&amp;height=640&amp;face=0_0_765_640');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/565 https://cnajini.tistory.com/565#entry565comment Wed, 11 Feb 2026 14:15:16 +0900 https://cnajini.tistory.com/564 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>「의약품 특허정보 활용 가이드」 발간 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 사항에 대해 식품의약품안전처의 입장을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="473" data-origin-height="517"><span data-url="https://blog.kakaocdn.net/dn/bjPEB7/dJMcaac8Sat/wL4pgdh1gwCeCXNDJKHrjK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bjPEB7/dJMcaac8Sat/wL4pgdh1gwCeCXNDJKHrjK/img.png"><img src="https://blog.kakaocdn.net/dn/bjPEB7/dJMcaac8Sat/wL4pgdh1gwCeCXNDJKHrjK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbjPEB7%2FdJMcaac8Sat%2FwL4pgdh1gwCeCXNDJKHrjK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="473" height="517" data-origin-width="473" data-origin-height="517"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「의약품 특허정보 활용 가이드」 발간 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 06일' 자로 한국의약품수출입협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="552" data-origin-height="782"><span data-url="https://blog.kakaocdn.net/dn/YOtAi/dJMcafMiNy7/I8kNbJwbNJrOIV35Xfqkz0/img.png" data-phocus="https://blog.kakaocdn.net/dn/YOtAi/dJMcafMiNy7/I8kNbJwbNJrOIV35Xfqkz0/img.png"><img src="https://blog.kakaocdn.net/dn/YOtAi/dJMcafMiNy7/I8kNbJwbNJrOIV35Xfqkz0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FYOtAi%2FdJMcafMiNy7%2FI8kNbJwbNJrOIV35Xfqkz0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="552" height="782" data-origin-width="552" data-origin-height="782"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="550" data-origin-height="734"><span data-url="https://blog.kakaocdn.net/dn/9pM6A/dJMcaaEdCmz/NQMjGkaJlCxXvh591JZ9PK/img.png" data-phocus="https://blog.kakaocdn.net/dn/9pM6A/dJMcaaEdCmz/NQMjGkaJlCxXvh591JZ9PK/img.png"><img src="https://blog.kakaocdn.net/dn/9pM6A/dJMcaaEdCmz/NQMjGkaJlCxXvh591JZ9PK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F9pM6A%2FdJMcaaEdCmz%2FNQMjGkaJlCxXvh591JZ9PK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="550" height="734" data-origin-width="550" data-origin-height="734"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>의약품 특허정보 활용 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bN8tS6/dJMcacINSYE/FZfPaeZEnEtAK84W29HKo1/%EC%9D%98%EC%95%BD%ED%92%88%20%ED%8A%B9%ED%97%88%EC%A0%95%EB%B3%B4%20%ED%99%9C%EC%9A%A9%20%EA%B0%80%EC%9D%B4%EB%93%9C_%EC%B5%9C%EC%A2%85.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품 특허정보 활용 가이드_최종.pdf</span></div> <div class="size">1.47MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpta.or.kr/importP/pharmaceutical_officialDoc_view">한국의약품수출입협회</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/564 https://cnajini.tistory.com/564#entry564comment Tue, 10 Feb 2026 13:08:42 +0900 https://cnajini.tistory.com/563 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 심사 검토서 작성 요령</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 동등생물의약품 심사 검토서 작성의 세부 지침을 정한 것으로서 식품의약품안전처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 심사 검토서 작성 요령</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 02월 03일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="540" data-origin-height="752"><span data-url="https://blog.kakaocdn.net/dn/lDYUt/dJMcaac6iZf/gmHEVKa9ytUKTCkdrclxkK/img.png" data-phocus="https://blog.kakaocdn.net/dn/lDYUt/dJMcaac6iZf/gmHEVKa9ytUKTCkdrclxkK/img.png"><img src="https://blog.kakaocdn.net/dn/lDYUt/dJMcaac6iZf/gmHEVKa9ytUKTCkdrclxkK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FlDYUt%2FdJMcaac6iZf%2FgmHEVKa9ytUKTCkdrclxkK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="540" height="752" data-origin-width="540" data-origin-height="752"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="516" data-origin-height="280"><span data-url="https://blog.kakaocdn.net/dn/czsWxd/dJMcadHB5Rr/uLtWzKfpIa1DHyYrQpRzk1/img.png" data-phocus="https://blog.kakaocdn.net/dn/czsWxd/dJMcadHB5Rr/uLtWzKfpIa1DHyYrQpRzk1/img.png"><img src="https://blog.kakaocdn.net/dn/czsWxd/dJMcadHB5Rr/uLtWzKfpIa1DHyYrQpRzk1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FczsWxd%2FdJMcadHB5Rr%2FuLtWzKfpIa1DHyYrQpRzk1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="516" height="280" data-origin-width="516" data-origin-height="280"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="538" data-origin-height="536"><span data-url="https://blog.kakaocdn.net/dn/KkW9b/dJMb99SMOHz/AqzayTH0LkwCc2VT8jnTR1/img.png" data-phocus="https://blog.kakaocdn.net/dn/KkW9b/dJMb99SMOHz/AqzayTH0LkwCc2VT8jnTR1/img.png"><img src="https://blog.kakaocdn.net/dn/KkW9b/dJMb99SMOHz/AqzayTH0LkwCc2VT8jnTR1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FKkW9b%2FdJMb99SMOHz%2FAqzayTH0LkwCc2VT8jnTR1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="538" height="536" data-origin-width="538" data-origin-height="536"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 심사 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/QBpIg/dJMcadAO78F/G2iVr9wMeYkkNvxbEbFkJk/%5B5200.02B%5D%EB%8F%99%EB%93%B1%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%8B%AC%EC%82%AC%2B%EA%B2%80%ED%86%A0%EC%84%9C%2B%EC%9E%91%EC%84%B1%2B%EC%9A%94%EB%A0%B9.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">[5200.02B]동등생물의약품+심사+검토서+작성+요령.pdf</span></div> <div class="size">1.51MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15227&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1770167516285" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="동등생물의약품 심사 검토서 작성 요령 이 지침서는 동등생물의약품 심사 검토서 작성의 세부 지침을 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한 것입니다. 첨부" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15227&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15227&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15227&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15227&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">동등생물의약품 심사 검토서 작성 요령 이 지침서는 동등생물의약품 심사 검토서 작성의 세부 지침을 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한 것입니다. 첨부</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/563 https://cnajini.tistory.com/563#entry563comment Wed, 4 Feb 2026 10:12:16 +0900 https://cnajini.tistory.com/562 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">「생물학적제제 기준 및 시험방법」 일부개정고시(안) 행정예고(공고 제2026-057호, 2026.1.30.)</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 사항을 행정예고한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="505" data-origin-height="283"><span data-url="https://blog.kakaocdn.net/dn/CyP0Z/dJMcabbYNJz/i8PHXssGOJeFYRPR5YlvVk/img.png" data-phocus="https://blog.kakaocdn.net/dn/CyP0Z/dJMcabbYNJz/i8PHXssGOJeFYRPR5YlvVk/img.png"><img src="https://blog.kakaocdn.net/dn/CyP0Z/dJMcabbYNJz/i8PHXssGOJeFYRPR5YlvVk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FCyP0Z%2FdJMcabbYNJz%2Fi8PHXssGOJeFYRPR5YlvVk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="505" height="283" data-origin-width="505" data-origin-height="283"/></span></figure> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="487" data-origin-height="68"><span data-url="https://blog.kakaocdn.net/dn/BONX9/dJMcab37t6c/5SSNn2eKhjR3vZrbHKpAeK/img.png" data-phocus="https://blog.kakaocdn.net/dn/BONX9/dJMcab37t6c/5SSNn2eKhjR3vZrbHKpAeK/img.png"><img src="https://blog.kakaocdn.net/dn/BONX9/dJMcab37t6c/5SSNn2eKhjR3vZrbHKpAeK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FBONX9%2FdJMcab37t6c%2F5SSNn2eKhjR3vZrbHKpAeK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="487" height="68" data-origin-width="487" data-origin-height="68"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">「생물학적제제 기준 및 시험방법」 일부개정고시(안) 행정예고(공고 제2026-057호, 2026.1.30.)</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 30일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="551" data-origin-height="500"><span data-url="https://blog.kakaocdn.net/dn/EwnoM/dJMb99LZwWF/38bfFQV6HEH60CWgdzVeq1/img.png" data-phocus="https://blog.kakaocdn.net/dn/EwnoM/dJMb99LZwWF/38bfFQV6HEH60CWgdzVeq1/img.png"><img src="https://blog.kakaocdn.net/dn/EwnoM/dJMb99LZwWF/38bfFQV6HEH60CWgdzVeq1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FEwnoM%2FdJMb99LZwWF%2F38bfFQV6HEH60CWgdzVeq1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="551" height="500" data-origin-width="551" data-origin-height="500"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="color: #333333; letter-spacing: 0px;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> </div> </div> </div> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물학적제제 기준 및 시험방법</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/dPIdnV/dJMcachFP7B/jOpIJAl1mFe5ME6NiOFHlK/%EC%83%9D%EB%AC%BC%ED%95%99%EC%A0%81%EC%A0%9C%EC%A0%9C%2B%EA%B8%B0%EC%A4%80%2B%EB%B0%8F%2B%EC%8B%9C%ED%97%98%EB%B0%A9%EB%B2%95%2B%EC%9D%BC%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%EC%95%88.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">생물학적제제+기준+및+시험방법+일부개정고시안.pdf</span></div> <div class="size">0.33MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bEM8T2/dJMcachFP7C/Q7kNp4d3JdKCH25F3LFk0k/%EA%B2%80%ED%86%A0%EC%9D%98%EA%B2%AC%EC%84%9C%2B%EC%96%91%EC%8B%9D%28%EC%83%9D%EB%AC%BC%ED%95%99%EC%A0%81%EC%A0%9C%EC%A0%9C%2B%EA%B8%B0%EC%A4%80%2B%EB%B0%8F%2B%EC%8B%9C%ED%97%98%EB%B0%A9%EB%B2%95%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">검토의견서+양식(생물학적제제+기준+및+시험방법).pdf</span></div> <div class="size">0.02MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_209/view.do?seq=44208&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1770080129657" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 | 식품의약품안전처" data-og-description="「생물학적제제 기준 및 시험방법」 일부개정고시(안) 행정예고(공고 제2026-057호, 2026.1.30.) 등록일 2026-01-30 조회수 428 식품의약품안전처 공고 제2026－57호 「생물학적제제 기준 및 시험방법」(식" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_209/view.do?seq=44208&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_209/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=44208&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_209/view.do?seq=44208&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_209/view.do?seq=44208&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 | 식품의약품안전처</p> <p class="og-desc" data-ke-size="size16">「생물학적제제 기준 및 시험방법」 일부개정고시(안) 행정예고(공고 제2026-057호, 2026.1.30.) 등록일 2026-01-30 조회수 428 식품의약품안전처 공고 제2026－57호 「생물학적제제 기준 및 시험방법」(식</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질관리(QC)/공정서 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/562 https://cnajini.tistory.com/562#entry562comment Tue, 3 Feb 2026 09:55:50 +0900 https://cnajini.tistory.com/561 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>CCS Template for Aseptic Preparation : Aseptic preparation 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서의 목적은&nbsp;미생물,&nbsp;입자,&nbsp;엔도톡신(발열성&nbsp;물질)&nbsp;및&nbsp;바이러스&nbsp;오염으로부터&nbsp;제품&nbsp;품질을&nbsp;보호하기&nbsp;위한&nbsp;오염&nbsp;관리&nbsp;전략을&nbsp;수립하는&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>CCS Template for Aseptic Preparation : Aseptic preparation 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 21일' 자로 sureGMP의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="601" data-origin-height="756"><span data-url="https://blog.kakaocdn.net/dn/nfhNd/dJMcad1QTxL/uumVjqGYH4tvNUFpHdhW91/img.png" data-phocus="https://blog.kakaocdn.net/dn/nfhNd/dJMcad1QTxL/uumVjqGYH4tvNUFpHdhW91/img.png"><img src="https://blog.kakaocdn.net/dn/nfhNd/dJMcad1QTxL/uumVjqGYH4tvNUFpHdhW91/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FnfhNd%2FdJMcad1QTxL%2FuumVjqGYH4tvNUFpHdhW91%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="601" height="756" data-origin-width="601" data-origin-height="756"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <p data-ke-size="size16"><span style="background-color: #ffffff; letter-spacing: 0px;">​​</span><span style="background-color: #ffffff; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="530" data-origin-height="694"><span data-url="https://blog.kakaocdn.net/dn/oBjnL/dJMcahwtOHJ/0jMKG00Mn75RKiTHqwO1a0/img.png" data-phocus="https://blog.kakaocdn.net/dn/oBjnL/dJMcahwtOHJ/0jMKG00Mn75RKiTHqwO1a0/img.png"><img src="https://blog.kakaocdn.net/dn/oBjnL/dJMcahwtOHJ/0jMKG00Mn75RKiTHqwO1a0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FoBjnL%2FdJMcahwtOHJ%2F0jMKG00Mn75RKiTHqwO1a0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="530" height="694" data-origin-width="530" data-origin-height="694"/></span></figure> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="534" data-origin-height="423"><span data-url="https://blog.kakaocdn.net/dn/Hri2x/dJMcacooGPl/vhlTeZ4XzlnLDZ25orYQY1/img.png" data-phocus="https://blog.kakaocdn.net/dn/Hri2x/dJMcacooGPl/vhlTeZ4XzlnLDZ25orYQY1/img.png"><img src="https://blog.kakaocdn.net/dn/Hri2x/dJMcacooGPl/vhlTeZ4XzlnLDZ25orYQY1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FHri2x%2FdJMcacooGPl%2FvhlTeZ4XzlnLDZ25orYQY1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="534" height="423" data-origin-width="534" data-origin-height="423"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 오염관리전략 수립 </span>진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/HTP9g/dJMcag5pjK8/jPYSxmKqnPKp23Hmstdb4K/%EB%AC%B4%EA%B7%A0%EC%A0%9C%EC%A1%B0%EA%B3%B5%EC%A0%95%2B%EC%98%A4%EC%97%BC%EA%B4%80%EB%A6%AC%2B%ED%85%9C%ED%94%8C%EB%A6%BF.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">무균제조공정+오염관리+템플릿.pdf</span></div> <div class="size">0.29MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bannXO/dJMcafFqude/NXf9mLZoFZgKKDK6WggM1k/CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023%2B%28%EC%98%81%EB%AC%B8%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023+(영문).pdf</span></div> <div class="size">0.31MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/cTx55u/dJMcad1QTCr/3LAU7ZkL5MbHgWk17NeJXK/CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023%2B%28%EC%98%81%EB%AC%B8%29.docx?attach=1&amp;knm=tfile.docx" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023+(영문).docx</span></div> <div class="size">0.10MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/w4K87/dJMcajgHVHn/ALUcFT25Pqaz3RRCCG3Bq1/CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023%2B%28%EB%B2%88%EC%97%AD%29.docx?attach=1&amp;knm=tfile.docx" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">CCS-Template-for-Aseptic-Preparation-Section-10-Issue-1-July-2023+(번역).docx</span></div> <div class="size">0.11MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.suregmp.com/forum/technology/read.jsp?no=11786">sureGMP</a></p> <figure id="og_1769560704644" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="https://www.suregmp.com/forum/technology/read.jsp?no=11786" data-og-description="" data-og-host="www.suregmp.com" data-og-source-url="https://www.suregmp.com/forum/technology/read.jsp?no=11786" data-og-url="https://www.suregmp.com/forum/technology/read.jsp?no=11786" data-og-image=""><a href="https://www.suregmp.com/forum/technology/read.jsp?no=11786" target="_blank" rel="noopener" data-source-url="https://www.suregmp.com/forum/technology/read.jsp?no=11786"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">https://www.suregmp.com/forum/technology/read.jsp?no=11786</p> <p class="og-desc" data-ke-size="size16">&nbsp;</p> <p class="og-host" data-ke-size="size16">www.suregmp.com</p> </div> </a></figure> <p data-ke-size="size16">-&gt; 참고로 위 싸이트는 가입을 해야 합니다.</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/561 https://cnajini.tistory.com/561#entry561comment Wed, 28 Jan 2026 09:39:02 +0900 https://cnajini.tistory.com/560 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">복합제 임상시험 가이드라인</span>&nbsp; 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 복합제 개발 시 임상시험에 대한 식품의약품안전처의 입장을 기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">복합제 임상시험 가이드라인</span>&nbsp; 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 26일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="529" data-origin-height="740"><span data-url="https://blog.kakaocdn.net/dn/kQiEP/dJMcafSXBhZ/Yh1JhCqsj271WDsJSqiVUk/img.png" data-phocus="https://blog.kakaocdn.net/dn/kQiEP/dJMcafSXBhZ/Yh1JhCqsj271WDsJSqiVUk/img.png"><img src="https://blog.kakaocdn.net/dn/kQiEP/dJMcafSXBhZ/Yh1JhCqsj271WDsJSqiVUk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FkQiEP%2FdJMcafSXBhZ%2FYh1JhCqsj271WDsJSqiVUk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="529" height="740" data-origin-width="529" data-origin-height="740"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="531" data-origin-height="572"><span data-url="https://blog.kakaocdn.net/dn/clLmrj/dJMcaaqzrwV/7UOJkhpF4qJ8vlHGyAvKE1/img.png" data-phocus="https://blog.kakaocdn.net/dn/clLmrj/dJMcaaqzrwV/7UOJkhpF4qJ8vlHGyAvKE1/img.png"><img src="https://blog.kakaocdn.net/dn/clLmrj/dJMcaaqzrwV/7UOJkhpF4qJ8vlHGyAvKE1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FclLmrj%2FdJMcaaqzrwV%2F7UOJkhpF4qJ8vlHGyAvKE1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="531" height="572" data-origin-width="531" data-origin-height="572"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="516" data-origin-height="735"><span data-url="https://blog.kakaocdn.net/dn/rCUrh/dJMcagYBbQD/NiLO0FDG1jxK9OGnvKzTXk/img.png" data-phocus="https://blog.kakaocdn.net/dn/rCUrh/dJMcagYBbQD/NiLO0FDG1jxK9OGnvKzTXk/img.png"><img src="https://blog.kakaocdn.net/dn/rCUrh/dJMcagYBbQD/NiLO0FDG1jxK9OGnvKzTXk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FrCUrh%2FdJMcagYBbQD%2FNiLO0FDG1jxK9OGnvKzTXk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="516" height="735" data-origin-width="516" data-origin-height="735"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">복합제 임상시험</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/dl0hiL/dJMcacBVIS3/iDzIRhk5qyk3xkcTnnF4f0/%E3%80%8C%EB%B3%B5%ED%95%A9%EC%A0%9C%2B%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%E3%80%8D%2B%28%EB%AF%BC%EC%9B%90%EC%9D%B8%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">「복합제+임상시험+가이드라인」+(민원인안내서).pdf</span></div> <div class="size">0.47MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15816&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1769476211494" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="복합제 임상시험 가이드라인 이전 이력 확인학기 ▼ 첨부파일 첨부파일 전체 다운로드 --&gt; 「복합제 임상시험 가이드라인」 (민원인안내서).pdf 다운받기 미리보기 첨부파일 보기 첨부파일 닫기" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15816&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15816&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15816&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15816&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">복합제 임상시험 가이드라인 이전 이력 확인학기 ▼ 첨부파일 첨부파일 전체 다운로드 --&gt; 「복합제 임상시험 가이드라인」 (민원인안내서).pdf 다운받기 미리보기 첨부파일 보기 첨부파일 닫기</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/560 https://cnajini.tistory.com/560#entry560comment Tue, 27 Jan 2026 11:10:26 +0900 https://cnajini.tistory.com/559 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>「의약품 안정공급 행정지원 안내서」(민원인 안내서) 제정 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 의료&middot;약업현장으로 의약품이 안정적으로 공급될 수 있도록 의약품을 생산&middot;수입하는 제약사에 대해 운영 중인 행정지원 사항을 알기 쉽게&nbsp;설명하기&nbsp;위해&nbsp;관련&nbsp;내용을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「의약품 안정공급 행정지원 안내서」(민원인 안내서) 제정 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 22일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="553" data-origin-height="760"><span data-url="https://blog.kakaocdn.net/dn/cPGcCO/dJMcaaqxZ5o/OfbSKtnqltM37wZXOHPy5K/img.png" data-phocus="https://blog.kakaocdn.net/dn/cPGcCO/dJMcaaqxZ5o/OfbSKtnqltM37wZXOHPy5K/img.png"><img src="https://blog.kakaocdn.net/dn/cPGcCO/dJMcaaqxZ5o/OfbSKtnqltM37wZXOHPy5K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcPGcCO%2FdJMcaaqxZ5o%2FOfbSKtnqltM37wZXOHPy5K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="553" height="760" data-origin-width="553" data-origin-height="760"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="552" data-origin-height="289"><span data-url="https://blog.kakaocdn.net/dn/edJgnf/dJMcahwrJEj/9gqhsVowkjIQ8PnF8VkjrK/img.png" data-phocus="https://blog.kakaocdn.net/dn/edJgnf/dJMcahwrJEj/9gqhsVowkjIQ8PnF8VkjrK/img.png"><img src="https://blog.kakaocdn.net/dn/edJgnf/dJMcahwrJEj/9gqhsVowkjIQ8PnF8VkjrK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FedJgnf%2FdJMcahwrJEj%2F9gqhsVowkjIQ8PnF8VkjrK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="552" height="289" data-origin-width="552" data-origin-height="289"/></span></figure> </p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>의약품 안전공급 행정지원 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/b61R1f/dJMcacomu1B/IIlSNy5KnggcJSWbj0yK5k/%EB%B6%99%EC%9E%84._%EC%9D%98%EC%95%BD%ED%92%88_%EC%95%88%EC%A0%95%EA%B3%B5%EA%B8%89_%ED%96%89%EC%A0%95%EC%A7%80%EC%9B%90_%EC%95%88%EB%82%B4%EC%84%9C_%28%EB%AF%BC%EC%9B%90%EC%9D%B8_%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">붙임._의약품_안정공급_행정지원_안내서_(민원인_안내서).pdf</span></div> <div class="size">0.79MB</div> </div> </a></figure> </p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/559 https://cnajini.tistory.com/559#entry559comment Mon, 26 Jan 2026 12:51:35 +0900 https://cnajini.tistory.com/558 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 심사자료 평가시 일반적 고려사항</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 원료의약품 품질 심사 시 일반적 고려사항에 대한 세부 지침을 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 심사자료 평가시 일반적 고려사항</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 22일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="528" data-origin-height="718"><span data-url="https://blog.kakaocdn.net/dn/br2Aw0/dJMcagxweUu/LF4BOzfLrKdwJqazymPIG0/img.png" data-phocus="https://blog.kakaocdn.net/dn/br2Aw0/dJMcagxweUu/LF4BOzfLrKdwJqazymPIG0/img.png"><img src="https://blog.kakaocdn.net/dn/br2Aw0/dJMcagxweUu/LF4BOzfLrKdwJqazymPIG0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbr2Aw0%2FdJMcagxweUu%2FLF4BOzfLrKdwJqazymPIG0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="528" height="718" data-origin-width="528" data-origin-height="718"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="530" data-origin-height="259"><span data-url="https://blog.kakaocdn.net/dn/bLDWhG/dJMcabpsvqI/UKtQN0eruROphRvt12ory0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bLDWhG/dJMcabpsvqI/UKtQN0eruROphRvt12ory0/img.png"><img src="https://blog.kakaocdn.net/dn/bLDWhG/dJMcabpsvqI/UKtQN0eruROphRvt12ory0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbLDWhG%2FdJMcabpsvqI%2FUKtQN0eruROphRvt12ory0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="530" height="259" data-origin-width="530" data-origin-height="259"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="391" data-origin-height="121"><span data-url="https://blog.kakaocdn.net/dn/z5eO3/dJMcahiUB3R/8KCMR6PhxCkrDzKBL416SK/img.png" data-phocus="https://blog.kakaocdn.net/dn/z5eO3/dJMcahiUB3R/8KCMR6PhxCkrDzKBL416SK/img.png"><img src="https://blog.kakaocdn.net/dn/z5eO3/dJMcahiUB3R/8KCMR6PhxCkrDzKBL416SK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fz5eO3%2FdJMcahiUB3R%2F8KCMR6PhxCkrDzKBL416SK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="391" height="121" data-origin-width="391" data-origin-height="121"/></span></figure> </div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 심사자료 평가 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/djQAbp/dJMcadndy72/8KF9QIbNuwyEX2xMRpWlZk/%EC%9B%90%EB%A3%8C%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EB%A1%9D%2B%EC%8B%AC%EC%82%AC%EC%9E%90%EB%A3%8C%2B%ED%8F%89%EA%B0%80%EC%8B%9C%2B%EC%9D%BC%EB%B0%98%EC%A0%81%2B%EA%B3%A0%EB%A0%A4%EC%82%AC%ED%95%AD%28GRP-MaPP-%EC%8B%AC%EC%82%AC%EA%B8%B0%EC%A4%80-09%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">원료의약품등록+심사자료+평가시+일반적+고려사항(GRP-MaPP-심사기준-09).pdf</span></div> <div class="size">0.36MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15226&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1769136125817" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="원료의약품등록 심사자료 평가시 일반적 고려사항 이 지침서는 원료의약품 품질 심사 시 일반적 고려사항에 대한 세부 지침을 정한 것입니다. 관련 업무에 참고하시기 바랍니다. 첨부파일 첨부" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15226&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15226&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15226&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15226&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">원료의약품등록 심사자료 평가시 일반적 고려사항 이 지침서는 원료의약품 품질 심사 시 일반적 고려사항에 대한 세부 지침을 정한 것입니다. 관련 업무에 참고하시기 바랍니다. 첨부파일 첨부</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/558 https://cnajini.tistory.com/558#entry558comment Sun, 25 Jan 2026 12:42:19 +0900 https://cnajini.tistory.com/557 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 검토서 작성기준</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 원료의약품등록 검토서 작성기준에 대한 세부 지침을 정한 것으로서&nbsp;식품의약품안전처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 검토서 작성기준</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 22일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="528" data-origin-height="714"><span data-url="https://blog.kakaocdn.net/dn/bhp6Pf/dJMcabXh3M7/mtVXy8YHDyLrIRqzg9ZXIK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bhp6Pf/dJMcabXh3M7/mtVXy8YHDyLrIRqzg9ZXIK/img.png"><img src="https://blog.kakaocdn.net/dn/bhp6Pf/dJMcabXh3M7/mtVXy8YHDyLrIRqzg9ZXIK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbhp6Pf%2FdJMcabXh3M7%2FmtVXy8YHDyLrIRqzg9ZXIK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="528" height="714" data-origin-width="528" data-origin-height="714"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="558" data-origin-height="208"><span data-url="https://blog.kakaocdn.net/dn/b6DJR5/dJMcajnraDB/sZ18ZFQLxsY3o0O2ijk8B0/img.png" data-phocus="https://blog.kakaocdn.net/dn/b6DJR5/dJMcajnraDB/sZ18ZFQLxsY3o0O2ijk8B0/img.png"><img src="https://blog.kakaocdn.net/dn/b6DJR5/dJMcajnraDB/sZ18ZFQLxsY3o0O2ijk8B0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fb6DJR5%2FdJMcajnraDB%2FsZ18ZFQLxsY3o0O2ijk8B0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="558" height="208" data-origin-width="558" data-origin-height="208"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="435" data-origin-height="142"><span data-url="https://blog.kakaocdn.net/dn/cQnh6C/dJMcacPrF9L/U6x9B8LcQW6NommBMikiE0/img.png" data-phocus="https://blog.kakaocdn.net/dn/cQnh6C/dJMcacPrF9L/U6x9B8LcQW6NommBMikiE0/img.png"><img src="https://blog.kakaocdn.net/dn/cQnh6C/dJMcacPrF9L/U6x9B8LcQW6NommBMikiE0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcQnh6C%2FdJMcacPrF9L%2FU6x9B8LcQW6NommBMikiE0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="435" height="142" data-origin-width="435" data-origin-height="142"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품등록 검토서 작성 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/ePNmb0/dJMcadHxqme/gI3OTajjW0XyLjsmVy8G9k/%EC%9B%90%EB%A3%8C%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EB%A1%9D%2B%EA%B2%80%ED%86%A0%EC%84%9C%2B%EC%9E%91%EC%84%B1%EA%B8%B0%EC%A4%80%28GRP-MaPP-%EC%8B%AC%EC%82%AC%EA%B8%B0%EC%A4%80-10%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">원료의약품등록+검토서+작성기준(GRP-MaPP-심사기준-10).pdf</span></div> <div class="size">0.48MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15225&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1769135979796" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="원료의약품등록 검토서 작성기준 이 지침서는 원료의약품등록 검토서 작성기준에 대한 내부 지침을 정한 것입니다. 관련 업무에 참고하시기 바랍니다. 첨부파일 첨부파일 전체 다운로드 --&gt; 원" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15225&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15225&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15225&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15225&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">원료의약품등록 검토서 작성기준 이 지침서는 원료의약품등록 검토서 작성기준에 대한 내부 지침을 정한 것입니다. 관련 업무에 참고하시기 바랍니다. 첨부파일 첨부파일 전체 다운로드 --&gt; 원</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/557 https://cnajini.tistory.com/557#entry557comment Sat, 24 Jan 2026 12:39:55 +0900 https://cnajini.tistory.com/556 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>의약품등의&nbsp;해외제조소&nbsp;변경신고&nbsp;민원&nbsp;설명회&nbsp;자료&nbsp;게시&nbsp;알림&nbsp;자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1294" data-origin-height="231"><span data-url="https://blog.kakaocdn.net/dn/mcMLd/dJMcafSVNzP/mFF79tnbGJvKGN3aZdRO31/img.png" data-phocus="https://blog.kakaocdn.net/dn/mcMLd/dJMcafSVNzP/mFF79tnbGJvKGN3aZdRO31/img.png"><img src="https://blog.kakaocdn.net/dn/mcMLd/dJMcafSVNzP/mFF79tnbGJvKGN3aZdRO31/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FmcMLd%2FdJMcafSVNzP%2FmFF79tnbGJvKGN3aZdRO31%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1294" height="231" data-origin-width="1294" data-origin-height="231"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>의약품등의&nbsp;해외제조소&nbsp;변경신고&nbsp;민원&nbsp;설명회&nbsp;자료&nbsp;게시&nbsp;알림&nbsp;자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 21일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="849" data-origin-height="610"><span data-url="https://blog.kakaocdn.net/dn/bKXytJ/dJMcabJLFJZ/hUJ1Qd9rifjJUBvaOyBKZk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bKXytJ/dJMcabJLFJZ/hUJ1Qd9rifjJUBvaOyBKZk/img.png"><img src="https://blog.kakaocdn.net/dn/bKXytJ/dJMcabJLFJZ/hUJ1Qd9rifjJUBvaOyBKZk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbKXytJ%2FdJMcabJLFJZ%2FhUJ1Qd9rifjJUBvaOyBKZk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="849" height="610" data-origin-width="849" data-origin-height="610"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="815" data-origin-height="563"><span data-url="https://blog.kakaocdn.net/dn/bxH1ZV/dJMcacWbmSA/cU5gJkIBr09nN7jrSytyE1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bxH1ZV/dJMcacWbmSA/cU5gJkIBr09nN7jrSytyE1/img.png"><img src="https://blog.kakaocdn.net/dn/bxH1ZV/dJMcacWbmSA/cU5gJkIBr09nN7jrSytyE1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbxH1ZV%2FdJMcacWbmSA%2FcU5gJkIBr09nN7jrSytyE1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="815" height="563" data-origin-width="815" data-origin-height="563"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #000000; text-align: left;">의약품등의 해외제조소 변경신고 민원&nbsp;</span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bI7GlR/dJMcacolYzD/KE41xmRTksn6LP3pj3vNw0/%EB%B6%99%EC%9E%84._%EC%9D%98%EC%95%BD%ED%92%88%EB%93%B1%EC%9D%98_%ED%95%B4%EC%99%B8%EC%A0%9C%EC%A1%B0%EC%86%8C_%EB%B3%80%EA%B2%BD%EC%8B%A0%EA%B3%A0_%EB%AF%BC%EC%9B%90_%EA%B4%80%EB%A0%A8_%EC%98%A8%EB%9D%BC%EC%9D%B8_%EC%84%A4%EB%AA%85%ED%9A%8C_%EC%9E%90%EB%A3%8C.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">붙임._의약품등의_해외제조소_변경신고_민원_관련_온라인_설명회_자료.pdf</span></div> <div class="size">0.68MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/law/policy/select/210677?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">입법/행정 &middot; 한국제약바이오협회</a></p> <figure id="og_1769042815340" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/law/policy/select/210677?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/k8gpF/dJMb8UHJeOJ/acEnDnu5RsrJG7e8aVlXf1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/c1SIVy/dJMb8YXFxdk/goedN56t3rxwK0ghCTeav1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/xGrcY/dJMb8U8NHPU/kzrmwdW8WxkgoD0Lt3MYG1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080"><a href="https://www.kpbma.or.kr/info/law/policy/select/210677?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/law/policy/select/210677?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/k8gpF/dJMb8UHJeOJ/acEnDnu5RsrJG7e8aVlXf1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/c1SIVy/dJMb8YXFxdk/goedN56t3rxwK0ghCTeav1/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/xGrcY/dJMb8U8NHPU/kzrmwdW8WxkgoD0Lt3MYG1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/556 https://cnajini.tistory.com/556#entry556comment Fri, 23 Jan 2026 10:47:08 +0900 https://cnajini.tistory.com/555 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 1월(상))」 배포 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 다음과 같은 내용을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1279" data-origin-height="210"><span data-url="https://blog.kakaocdn.net/dn/mG023/dJMb996eNY7/ws0SuJ8lf8FeCh0eRwZHk1/img.png" data-phocus="https://blog.kakaocdn.net/dn/mG023/dJMb996eNY7/ws0SuJ8lf8FeCh0eRwZHk1/img.png"><img src="https://blog.kakaocdn.net/dn/mG023/dJMb996eNY7/ws0SuJ8lf8FeCh0eRwZHk1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FmG023%2FdJMb996eNY7%2Fws0SuJ8lf8FeCh0eRwZHk1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1279" height="210" data-origin-width="1279" data-origin-height="210"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>식약처 「의료제품 분야, 최신 해외 동향 정보지(2026년 1월(상))」 배포 알림 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 21일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="564" data-origin-height="803"><span data-url="https://blog.kakaocdn.net/dn/duIuh5/dJMcaiB35oN/riww0d6S4RPsODdzUIZJg1/img.png" data-phocus="https://blog.kakaocdn.net/dn/duIuh5/dJMcaiB35oN/riww0d6S4RPsODdzUIZJg1/img.png"><img src="https://blog.kakaocdn.net/dn/duIuh5/dJMcaiB35oN/riww0d6S4RPsODdzUIZJg1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FduIuh5%2FdJMcaiB35oN%2Friww0d6S4RPsODdzUIZJg1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="564" height="803" data-origin-width="564" data-origin-height="803"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <p data-ke-size="size16"><span style="background-color: #ffffff; letter-spacing: 0px;">​</span><span style="background-color: #ffffff; color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="555" data-origin-height="773"><span data-url="https://blog.kakaocdn.net/dn/BBKdd/dJMcagddBLR/P3EiTgBhHXmVUKFXewVwdK/img.png" data-phocus="https://blog.kakaocdn.net/dn/BBKdd/dJMcagddBLR/P3EiTgBhHXmVUKFXewVwdK/img.png"><img src="https://blog.kakaocdn.net/dn/BBKdd/dJMcagddBLR/P3EiTgBhHXmVUKFXewVwdK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FBBKdd%2FdJMcagddBLR%2FP3EiTgBhHXmVUKFXewVwdK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="555" height="773" data-origin-width="555" data-origin-height="773"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>의료제품 분야 최신 해외 동향 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/U2yun/dJMcafZFA5V/z6TPeaDBbQ3NNK7K1w9aGK/%EC%9D%98%EB%A3%8C%EC%A0%9C%ED%92%88_%EB%B6%84%EC%95%BC%EF%BC%8C_%EC%B5%9C%EC%8B%A0_%ED%95%B4%EC%99%B8_%EB%8F%99%ED%96%A5_%EC%A0%95%EB%B3%B4%EC%A7%80%282026%EB%85%84_1%EC%9B%94%28%EC%83%81%29%29.zip?attach=1&amp;knm=tfile.zip" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의료제품_분야，_최신_해외_동향_정보지(2026년_1월(상)).zip</span></div> <div class="size">1.91MB</div> </div> </a></figure> </div> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">공지사항 &middot; 한국제약바이오협회</a></p> <figure id="og_1769042616252" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/fraEF/dJMb9dHh5ML/UHE9IGi1YvLFbR8GuC1hqk/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b722e6/dJMb9cBCbUv/HAYcZ0gnMIvMjg5E6s37h0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/3r6ID/dJMb9frzv5P/8u48YsWLKVKsxSkFx7RrJ1/img.png?width=1263&amp;height=687&amp;face=0_0_1263_687"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248765?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/fraEF/dJMb9dHh5ML/UHE9IGi1YvLFbR8GuC1hqk/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/b722e6/dJMb9cBCbUv/HAYcZ0gnMIvMjg5E6s37h0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/3r6ID/dJMb9frzv5P/8u48YsWLKVKsxSkFx7RrJ1/img.png?width=1263&amp;height=687&amp;face=0_0_1263_687');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/555 https://cnajini.tistory.com/555#entry555comment Thu, 22 Jan 2026 09:43:52 +0900 https://cnajini.tistory.com/554 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>비알코올지방간염&nbsp;치료제&nbsp;임상시험&nbsp;가이드라인자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 비알코올지방간염 치료제의 임상시험에 대한 식품의약품안전처의 입장을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>비알코올지방간염&nbsp;치료제&nbsp;임상시험&nbsp;가이드라인자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 07일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="552" data-origin-height="804"><span data-url="https://blog.kakaocdn.net/dn/Pw069/dJMb99ZoDSb/ITrpmQwtjK2QrLPFq724v1/img.png" data-phocus="https://blog.kakaocdn.net/dn/Pw069/dJMb99ZoDSb/ITrpmQwtjK2QrLPFq724v1/img.png"><img src="https://blog.kakaocdn.net/dn/Pw069/dJMb99ZoDSb/ITrpmQwtjK2QrLPFq724v1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FPw069%2FdJMb99ZoDSb%2FITrpmQwtjK2QrLPFq724v1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="552" height="804" data-origin-width="552" data-origin-height="804"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="541" data-origin-height="231"><span data-url="https://blog.kakaocdn.net/dn/4psM9/dJMcaajGVwH/OBaKlOX3QItKlbKKA1joX1/img.png" data-phocus="https://blog.kakaocdn.net/dn/4psM9/dJMcaajGVwH/OBaKlOX3QItKlbKKA1joX1/img.png"><img src="https://blog.kakaocdn.net/dn/4psM9/dJMcaajGVwH/OBaKlOX3QItKlbKKA1joX1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F4psM9%2FdJMcaajGVwH%2FOBaKlOX3QItKlbKKA1joX1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="541" height="231" data-origin-width="541" data-origin-height="231"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="566" data-origin-height="767"><span data-url="https://blog.kakaocdn.net/dn/b8SRgn/dJMcafL4eZG/KkNamiRV5GLbq4KwNk8pP1/img.png" data-phocus="https://blog.kakaocdn.net/dn/b8SRgn/dJMcafL4eZG/KkNamiRV5GLbq4KwNk8pP1/img.png"><img src="https://blog.kakaocdn.net/dn/b8SRgn/dJMcafL4eZG/KkNamiRV5GLbq4KwNk8pP1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fb8SRgn%2FdJMcafL4eZG%2FKkNamiRV5GLbq4KwNk8pP1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="566" height="767" data-origin-width="566" data-origin-height="767"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="558" data-origin-height="753"><span data-url="https://blog.kakaocdn.net/dn/9oE5t/dJMcadHrNxK/7b9txkSmjF3MxaOv5ZXGdk/img.png" data-phocus="https://blog.kakaocdn.net/dn/9oE5t/dJMcadHrNxK/7b9txkSmjF3MxaOv5ZXGdk/img.png"><img src="https://blog.kakaocdn.net/dn/9oE5t/dJMcadHrNxK/7b9txkSmjF3MxaOv5ZXGdk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F9oE5t%2FdJMcadHrNxK%2F7b9txkSmjF3MxaOv5ZXGdk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="558" height="753" data-origin-width="558" data-origin-height="753"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>비알코올지방간염 치료제 임상시험 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bS3toY/dJMcabv8lUv/GNne0zI3ev5QYCQgA4NdN1/%EB%B9%84%EC%95%8C%EC%BD%94%EC%98%AC%EC%A7%80%EB%B0%A9%EA%B0%84%EC%97%BC%2B%EC%B9%98%EB%A3%8C%EC%A0%9C%2B%EC%9E%84%EC%83%81%EC%8B%9C%ED%97%98%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">비알코올지방간염+치료제+임상시험+가이드라인(민원인+안내서).pdf</span></div> <div class="size">2.39MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15812&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767925860877" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="비알코올지방간염 치료제 임상시험 가이드라인 비알코올지방간염 치료제의 개발지원을 위해 비알코올지방간염 치료제 임상시험 가이드라인(민원인 안내서)를 제정하였음을 알려드리니 업무" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15812&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15812&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15812&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15812&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">비알코올지방간염 치료제 임상시험 가이드라인 비알코올지방간염 치료제의 개발지원을 위해 비알코올지방간염 치료제 임상시험 가이드라인(민원인 안내서)를 제정하였음을 알려드리니 업무</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/554 https://cnajini.tistory.com/554#entry554comment Mon, 12 Jan 2026 12:31:15 +0900 https://cnajini.tistory.com/553 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 안전정보 음성&middot;수어영상 제작 안내서</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 「약사법」 제59조의2(시각&middot;청각장애인을 위한 의약품의 표시)에 따라 의약품의 용기 또는 포장, 첨부문서에 표시하여야 하는 음성&middot;수어영상변환용 코드를 활용한 의약품 안전정보 콘텐츠 제작 시 고려하여야 하는 사항에 대해 알기 쉽게 설명하거나 식품의약품안전처의 입장을&nbsp;기술한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 안전정보 음성&middot;수어영상 제작 안내서</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 07일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="540" data-origin-height="760"><span data-url="https://blog.kakaocdn.net/dn/nmoVk/dJMcafSQCMn/xnYc2YkKkY1vSSkooNKYck/img.png" data-phocus="https://blog.kakaocdn.net/dn/nmoVk/dJMcafSQCMn/xnYc2YkKkY1vSSkooNKYck/img.png"><img src="https://blog.kakaocdn.net/dn/nmoVk/dJMcafSQCMn/xnYc2YkKkY1vSSkooNKYck/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FnmoVk%2FdJMcafSQCMn%2FxnYc2YkKkY1vSSkooNKYck%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="540" height="760" data-origin-width="540" data-origin-height="760"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="542" data-origin-height="274"><span data-url="https://blog.kakaocdn.net/dn/bhbTGV/dJMcahXrmAz/9PClFllzCAbK0kPz9Dw1Z0/img.png" data-phocus="https://blog.kakaocdn.net/dn/bhbTGV/dJMcahXrmAz/9PClFllzCAbK0kPz9Dw1Z0/img.png"><img src="https://blog.kakaocdn.net/dn/bhbTGV/dJMcahXrmAz/9PClFllzCAbK0kPz9Dw1Z0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbhbTGV%2FdJMcahXrmAz%2F9PClFllzCAbK0kPz9Dw1Z0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="542" height="274" data-origin-width="542" data-origin-height="274"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="547" data-origin-height="734"><span data-url="https://blog.kakaocdn.net/dn/cdQLHc/dJMb99ZoDM9/5Vz91KPmmYWoeKghTgyXGk/img.png" data-phocus="https://blog.kakaocdn.net/dn/cdQLHc/dJMb99ZoDM9/5Vz91KPmmYWoeKghTgyXGk/img.png"><img src="https://blog.kakaocdn.net/dn/cdQLHc/dJMb99ZoDM9/5Vz91KPmmYWoeKghTgyXGk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcdQLHc%2FdJMb99ZoDM9%2F5Vz91KPmmYWoeKghTgyXGk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="547" height="734" data-origin-width="547" data-origin-height="734"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품 안전정보 음성&middot;수어영상 제작 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/JtsIW/dJMb99ZoDNA/aYXfUOxjUmtC7HOTAy5zoK/%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%95%88%EC%A0%84%EC%A0%95%EB%B3%B4%2B%EC%9D%8C%EC%84%B1%26middot%3B%EC%88%98%EC%96%B4%EC%98%81%EC%83%81%2B%EC%A0%9C%EC%9E%91%2B%EC%95%88%EB%82%B4%EC%84%9C%28%EB%AF%BC%EC%9B%90%EC%9D%B8%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품+안전정보+음성&amp;middot;수어영상+제작+안내서(민원인안내서).pdf</span></div> <div class="size">0.98MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15811&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767925652850" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="의약품 안전정보 음성&middot;수어영상 제작 안내서 식품의약품안전처(의약품안전국)에서는 의약품 안전정보 음성&middot;수어영상을 제공하고 있습니다. 약사법령 및 「의약품 표시 등에 관한 규정」 개정" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15811&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15811&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15811&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15811&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">의약품 안전정보 음성&middot;수어영상 제작 안내서 식품의약품안전처(의약품안전국)에서는 의약품 안전정보 음성&middot;수어영상을 제공하고 있습니다. 약사법령 및 「의약품 표시 등에 관한 규정」 개정</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/553 https://cnajini.tistory.com/553#entry553comment Sun, 11 Jan 2026 12:28:03 +0900 https://cnajini.tistory.com/552 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">제네릭의약품 CTD 품질평가자료 심사 시 일반적 고려사항</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 제네릭의약품(원료의약품 포함) CTD 품질평가자료 심사 시 일반적 고려사항에 대한 정보를 제공하기 위한 것으로, 식품의약품안전처 관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">제네릭의약품 CTD 품질평가자료 심사 시 일반적 고려사항</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2026년 01월 06일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="547" data-origin-height="716"><span data-url="https://blog.kakaocdn.net/dn/bl2ew4/dJMcaa423l6/GBTLfCXpRkPwQAAVM5z8jk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bl2ew4/dJMcaa423l6/GBTLfCXpRkPwQAAVM5z8jk/img.png"><img src="https://blog.kakaocdn.net/dn/bl2ew4/dJMcaa423l6/GBTLfCXpRkPwQAAVM5z8jk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbl2ew4%2FdJMcaa423l6%2FGBTLfCXpRkPwQAAVM5z8jk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="547" height="716" data-origin-width="547" data-origin-height="716"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="552" data-origin-height="246"><span data-url="https://blog.kakaocdn.net/dn/bh27ZD/dJMcafrK0k7/KXLJvUuKROym1uFDXUAwA1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bh27ZD/dJMcafrK0k7/KXLJvUuKROym1uFDXUAwA1/img.png"><img src="https://blog.kakaocdn.net/dn/bh27ZD/dJMcafrK0k7/KXLJvUuKROym1uFDXUAwA1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbh27ZD%2FdJMcafrK0k7%2FKXLJvUuKROym1uFDXUAwA1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="552" height="246" data-origin-width="552" data-origin-height="246"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="553" data-origin-height="546"><span data-url="https://blog.kakaocdn.net/dn/c7MwoW/dJMcabCSGga/Iv7X2uCdIePgIhR1gsHBVk/img.png" data-phocus="https://blog.kakaocdn.net/dn/c7MwoW/dJMcabCSGga/Iv7X2uCdIePgIhR1gsHBVk/img.png"><img src="https://blog.kakaocdn.net/dn/c7MwoW/dJMcabCSGga/Iv7X2uCdIePgIhR1gsHBVk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fc7MwoW%2FdJMcabCSGga%2FIv7X2uCdIePgIhR1gsHBVk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="553" height="546" data-origin-width="553" data-origin-height="546"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">제네릭의약품 CTD 품질평가자료 심사 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/x2LSY/dJMcacu1VIs/3nDtXCGfezjDsBVaOZI3j0/%EC%A0%9C%EB%84%A4%EB%A6%AD%EC%9D%98%EC%95%BD%ED%92%88%2BCTD%2B%ED%92%88%EC%A7%88%ED%8F%89%EA%B0%80%EC%9E%90%EB%A3%8C%2B%EC%8B%AC%EC%82%AC%2B%EC%8B%9C%2B%EC%9D%BC%EB%B0%98%EC%A0%81%2B%EA%B3%A0%EB%A0%A4%EC%82%AC%ED%95%AD%28%EA%B3%B5%EB%AC%B4%EC%9B%90%EC%A7%80%EC%B9%A8%EC%84%9C%29_%EC%A0%9C%EC%A0%95_%2B%EB%88%84%EB%A6%AC%EC%A7%91%EA%B2%8C%EC%8B%9C.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">제네릭의약품+CTD+품질평가자료+심사+시+일반적+고려사항(공무원지침서)_제정_+누리집게시.pdf</span></div> <div class="size">0.51MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15221&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767772292125" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="제네릭의약품 CTD 품질평가자료 심사 시 일반적 고려사항 제네릭의약품 개발 특성을 고려한 국제 수준의 원료의약품 및 완제의약품 국제공통기술문서(CTD) 품질평가자료의 심사기준을 주요 내용" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15221&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15221&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15221&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15221&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">제네릭의약품 CTD 품질평가자료 심사 시 일반적 고려사항 제네릭의약품 개발 특성을 고려한 국제 수준의 원료의약품 및 완제의약품 국제공통기술문서(CTD) 품질평가자료의 심사기준을 주요 내용</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/552 https://cnajini.tistory.com/552#entry552comment Sat, 10 Jan 2026 17:51:54 +0900 https://cnajini.tistory.com/551 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f2f4f7; color: #333333; text-align: start;">[의약품] 대한민국약전포럼 발간(Vol.22, No.2)</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 식품의약품안전처 연구개발사업 결과를 근거로 마련된 대한민국약전 개정(안)과 약전 관련 정보를 국내&middot;외에 공유하고자 발행된 것입니다.</span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f2f4f7; color: #333333; text-align: start;">[의약품] 대한민국약전포럼 발간(Vol.22, No.2)</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 30일' 자로 식품의약품안전평가원의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="603" data-origin-height="837"><span data-url="https://blog.kakaocdn.net/dn/7JXMZ/dJMcagqDJ4I/9NkKk725N52CqiRbPqXu50/img.png" data-phocus="https://blog.kakaocdn.net/dn/7JXMZ/dJMcagqDJ4I/9NkKk725N52CqiRbPqXu50/img.png"><img src="https://blog.kakaocdn.net/dn/7JXMZ/dJMcagqDJ4I/9NkKk725N52CqiRbPqXu50/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F7JXMZ%2FdJMcagqDJ4I%2F9NkKk725N52CqiRbPqXu50%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="603" height="837" data-origin-width="603" data-origin-height="837"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="561" data-origin-height="762"><span data-url="https://blog.kakaocdn.net/dn/4m5bH/dJMcafFhl6Z/OO5YnGuNIKYyzdGF7AnWKK/img.png" data-phocus="https://blog.kakaocdn.net/dn/4m5bH/dJMcafFhl6Z/OO5YnGuNIKYyzdGF7AnWKK/img.png"><img src="https://blog.kakaocdn.net/dn/4m5bH/dJMcafFhl6Z/OO5YnGuNIKYyzdGF7AnWKK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F4m5bH%2FdJMcafFhl6Z%2FOO5YnGuNIKYyzdGF7AnWKK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="561" height="762" data-origin-width="561" data-origin-height="762"/></span></figure> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="549" data-origin-height="524"><span data-url="https://blog.kakaocdn.net/dn/cRmTPt/dJMcafZziGV/fow03aAd2S4GbAVkXHWGA1/img.png" data-phocus="https://blog.kakaocdn.net/dn/cRmTPt/dJMcafZziGV/fow03aAd2S4GbAVkXHWGA1/img.png"><img src="https://blog.kakaocdn.net/dn/cRmTPt/dJMcafZziGV/fow03aAd2S4GbAVkXHWGA1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcRmTPt%2FdJMcafZziGV%2Ffow03aAd2S4GbAVkXHWGA1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="549" height="524" data-origin-width="549" data-origin-height="524"/></span></figure> </div> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f2f4f7; color: #333333; text-align: start;">[의약품] 대한민국약전</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/biBLYY/dJMcagxpfa0/9413MpxzSRIvMM0N6q5Le0/%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%ED%8F%AC%EB%9F%BC%2B%28Vol.22%2C%2BNo.2%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">대한민국약전포럼+(Vol.22,+No.2).pdf</span></div> <div class="size">8.48MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12861">정보마당 &gt; 간행물&middot;자료집 &gt; 대한민국약전포럼 발간(Vol.22, No.2) | 식품의약품안전평가원</a></p> <figure id="og_1767577414440" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="정보마당 &gt; 간행물&middot;자료집 &gt; 대한민국약전포럼 발간(Vol.22, No.2) | 식품의약품안전평가원" data-og-description="우리 원(의약품연구과)에서는 대한민국약전의 과학적 타당성과 합리성을 강화하고 최신 의약품 품질 정보 등을 제공하는 동시에 제약 현장과 의약품 분야 전문가 등 다양한 의견을 수렴하여 약" data-og-host="www.nifds.go.kr" data-og-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12861" data-og-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12861" data-og-image=""><a href="https://www.nifds.go.kr/brd/m_18/view.do?seq=12861" target="_blank" rel="noopener" data-source-url="https://www.nifds.go.kr/brd/m_18/view.do?seq=12861"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">정보마당 &gt; 간행물&middot;자료집 &gt; 대한민국약전포럼 발간(Vol.22, No.2) | 식품의약품안전평가원</p> <p class="og-desc" data-ke-size="size16">우리 원(의약품연구과)에서는 대한민국약전의 과학적 타당성과 합리성을 강화하고 최신 의약품 품질 정보 등을 제공하는 동시에 제약 현장과 의약품 분야 전문가 등 다양한 의견을 수렴하여 약</p> <p class="og-host" data-ke-size="size16">www.nifds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질관리(QC)/공정서 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/551 https://cnajini.tistory.com/551#entry551comment Fri, 9 Jan 2026 11:43:54 +0900 https://cnajini.tistory.com/550 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오의약품 원료물질 제조소 GMP 인증을 위한 제출 자료 등 안내서</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 바이오의약품 원료물질 관련 제조업체 GMP 인증에 관한 세부 지침에 대한 식품의약품안전처의 입장을 기술한 것입니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오의약품 원료물질 제조소 GMP 인증을 위한 제출 자료 등 안내서</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="555" data-origin-height="776"><span data-url="https://blog.kakaocdn.net/dn/cIzgWH/dJMcahb0X9r/lmbb5KGhnV6pt7ofhZ45jK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cIzgWH/dJMcahb0X9r/lmbb5KGhnV6pt7ofhZ45jK/img.png"><img src="https://blog.kakaocdn.net/dn/cIzgWH/dJMcahb0X9r/lmbb5KGhnV6pt7ofhZ45jK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcIzgWH%2FdJMcahb0X9r%2Flmbb5KGhnV6pt7ofhZ45jK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="555" height="776" data-origin-width="555" data-origin-height="776"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="564" data-origin-height="298"><span data-url="https://blog.kakaocdn.net/dn/bSHCGq/dJMcac2OEDe/2dOypcyhKxXLZ8X6CNWgok/img.png" data-phocus="https://blog.kakaocdn.net/dn/bSHCGq/dJMcac2OEDe/2dOypcyhKxXLZ8X6CNWgok/img.png"><img src="https://blog.kakaocdn.net/dn/bSHCGq/dJMcac2OEDe/2dOypcyhKxXLZ8X6CNWgok/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbSHCGq%2FdJMcac2OEDe%2F2dOypcyhKxXLZ8X6CNWgok%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="564" height="298" data-origin-width="564" data-origin-height="298"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="554" data-origin-height="621"><span data-url="https://blog.kakaocdn.net/dn/bABc7j/dJMcaiaVUsx/injGB9mabmnaTgysxvKD71/img.png" data-phocus="https://blog.kakaocdn.net/dn/bABc7j/dJMcaiaVUsx/injGB9mabmnaTgysxvKD71/img.png"><img src="https://blog.kakaocdn.net/dn/bABc7j/dJMcaiaVUsx/injGB9mabmnaTgysxvKD71/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbABc7j%2FdJMcaiaVUsx%2FinjGB9mabmnaTgysxvKD71%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="554" height="621" data-origin-width="554" data-origin-height="621"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">바이오의약품 원료물질 제조소 GMP 인증을 위한 제출 자료 등 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/ssgAX/dJMcacV4VEh/BTbRmcdq7bUvQMFf3eiDVk/%EB%B0%94%EC%9D%B4%EC%98%A4%EC%9D%98%EC%95%BD%ED%92%88%2B%EC%9B%90%EB%A3%8C%EB%AC%BC%EC%A7%88%2B%EC%A0%9C%EC%A1%B0%EC%86%8C%2BGMP%2B%EC%9D%B8%EC%A6%9D%EC%9D%84%2B%EC%9C%84%ED%95%9C%2B%EC%A0%9C%EC%B6%9C%2B%EC%9E%90%EB%A3%8C%2B%EB%93%B1%2B%EC%95%88%EB%82%B4%EC%84%9C%28%EB%AF%BC%EC%9B%90%EC%9D%B8%2B%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">바이오의약품+원료물질+제조소+GMP+인증을+위한+제출+자료+등+안내서(민원인+안내서).pdf</span></div> <div class="size">1.38MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15807&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767576771690" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="바이오의약품 원료물질 제조소 GMP 인증을 위한 제출 자료 등 안내서 등록번호 안내서-1376-03 분야 고시일 2025-12-30 등록일 2025-12-31 조회수 201 식품의약품안전처는 바이오의약품 원료물질 수출과 " data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15807&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15807&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15807&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15807&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">바이오의약품 원료물질 제조소 GMP 인증을 위한 제출 자료 등 안내서 등록번호 안내서-1376-03 분야 고시일 2025-12-30 등록일 2025-12-31 조회수 201 식품의약품안전처는 바이오의약품 원료물질 수출과</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/550 https://cnajini.tistory.com/550#entry550comment Thu, 8 Jan 2026 11:33:09 +0900 https://cnajini.tistory.com/548 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 품목허가&middot;심사 업무절차</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 동등생물의약품 품목허가 신청 시 허가‧심사 업무절차를 정한 것으로서 식품의약품안전처 관련 부서 담당 직원의 업무처리를 위한 것입니다.</span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 품목허가&middot;심사 업무절차</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 30일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="524" data-origin-height="750"><span data-url="https://blog.kakaocdn.net/dn/qFqmQ/dJMcafSOIyc/CIusmO0oOq1yZSUCsy5ozk/img.png" data-phocus="https://blog.kakaocdn.net/dn/qFqmQ/dJMcafSOIyc/CIusmO0oOq1yZSUCsy5ozk/img.png"><img src="https://blog.kakaocdn.net/dn/qFqmQ/dJMcafSOIyc/CIusmO0oOq1yZSUCsy5ozk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FqFqmQ%2FdJMcafSOIyc%2FCIusmO0oOq1yZSUCsy5ozk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="524" height="750" data-origin-width="524" data-origin-height="750"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="532" data-origin-height="205"><span data-url="https://blog.kakaocdn.net/dn/ua6C0/dJMcai20Trc/6rycv95zFxJi1kwzIuUVgK/img.png" data-phocus="https://blog.kakaocdn.net/dn/ua6C0/dJMcai20Trc/6rycv95zFxJi1kwzIuUVgK/img.png"><img src="https://blog.kakaocdn.net/dn/ua6C0/dJMcai20Trc/6rycv95zFxJi1kwzIuUVgK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fua6C0%2FdJMcai20Trc%2F6rycv95zFxJi1kwzIuUVgK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="532" height="205" data-origin-width="532" data-origin-height="205"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="539" data-origin-height="690"><span data-url="https://blog.kakaocdn.net/dn/pFImA/dJMcachtDVn/G1EjCYIkFWvEGMPg72RBb1/img.png" data-phocus="https://blog.kakaocdn.net/dn/pFImA/dJMcachtDVn/G1EjCYIkFWvEGMPg72RBb1/img.png"><img src="https://blog.kakaocdn.net/dn/pFImA/dJMcachtDVn/G1EjCYIkFWvEGMPg72RBb1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FpFImA%2FdJMcachtDVn%2FG1EjCYIkFWvEGMPg72RBb1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="539" height="690" data-origin-width="539" data-origin-height="690"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">동등생물의약품 품목허가&middot;심사 업무절차</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/DwQqr/dJMcafedlmD/iL2FDUOHxdcju1znLeM0V0/%EB%8F%99%EB%93%B1%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%2B%ED%92%88%EB%AA%A9%ED%97%88%EA%B0%80%EF%BC%9F%EC%8B%AC%EC%82%AC%2B%EC%97%85%EB%AC%B4%EC%A0%88%EC%B0%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%EC%A7%80%EC%B9%A8%EC%84%9C%29%2B%EC%A0%9C%EC%A0%95.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">동등생물의약품+품목허가？심사+업무절차(공무원지침서)+제정.pdf</span></div> <div class="size">0.37MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15219&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767576303810" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="동등생물의약품 품목허가&middot;심사 업무절차 동등생물의약품 품목허가 업무 수행 시 신속한 처리를 위하여 허가 수수료 개정('25.12.17.)에 따라 동등생물의약품 허가의 신속성, 투명성 및 통일성 제" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15219&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15219&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15219&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15219&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">동등생물의약품 품목허가&middot;심사 업무절차 동등생물의약품 품목허가 업무 수행 시 신속한 처리를 위하여 허가 수수료 개정('25.12.17.)에 따라 동등생물의약품 허가의 신속성, 투명성 및 통일성 제</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/548 https://cnajini.tistory.com/548#entry548comment Wed, 7 Jan 2026 11:25:16 +0900 https://cnajini.tistory.com/547 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인 신청 민원의 처리 절차</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 국가출하승인 신청 민원 처리의 세부 지침을 정한 것으로서 식품의약품안전처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인 신청 민원의 처리 절차</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 30일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="570" data-origin-height="770"><span data-url="https://blog.kakaocdn.net/dn/yIccb/dJMcafSOIoE/XaRHZ3FtCKy2NoxDYcESv0/img.png" data-phocus="https://blog.kakaocdn.net/dn/yIccb/dJMcafSOIoE/XaRHZ3FtCKy2NoxDYcESv0/img.png"><img src="https://blog.kakaocdn.net/dn/yIccb/dJMcafSOIoE/XaRHZ3FtCKy2NoxDYcESv0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FyIccb%2FdJMcafSOIoE%2FXaRHZ3FtCKy2NoxDYcESv0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="570" height="770" data-origin-width="570" data-origin-height="770"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="567" data-origin-height="527"><span data-url="https://blog.kakaocdn.net/dn/bPzlVO/dJMcabizRr2/tijHemg1fXmcJrOd8HaD0K/img.png" data-phocus="https://blog.kakaocdn.net/dn/bPzlVO/dJMcabizRr2/tijHemg1fXmcJrOd8HaD0K/img.png"><img src="https://blog.kakaocdn.net/dn/bPzlVO/dJMcabizRr2/tijHemg1fXmcJrOd8HaD0K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbPzlVO%2FdJMcabizRr2%2FtijHemg1fXmcJrOd8HaD0K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="567" height="527" data-origin-width="567" data-origin-height="527"/></span></figure> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="559" data-origin-height="765"><span data-url="https://blog.kakaocdn.net/dn/by8o4V/dJMcacPjzpJ/9jwdPh1aUi8KUZrlz8Kwn0/img.png" data-phocus="https://blog.kakaocdn.net/dn/by8o4V/dJMcacPjzpJ/9jwdPh1aUi8KUZrlz8Kwn0/img.png"><img src="https://blog.kakaocdn.net/dn/by8o4V/dJMcacPjzpJ/9jwdPh1aUi8KUZrlz8Kwn0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fby8o4V%2FdJMcacPjzpJ%2F9jwdPh1aUi8KUZrlz8Kwn0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="559" height="765" data-origin-width="559" data-origin-height="765"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">국가출하승인 신청 민원의 처리 절차</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/0KcCW/dJMcacPjzp5/auxgUH6uEUDCGl5ixE0IZ0/%5B5300.01%5D%2B%EA%B5%AD%EA%B0%80%EC%B6%9C%ED%95%98%EC%8A%B9%EC%9D%B8%2B%EC%8B%A0%EC%B2%AD%2B%EB%AF%BC%EC%9B%90%EC%9D%98%2B%EC%B2%98%EB%A6%AC%2B%EC%A0%88%EC%B0%A8%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29_Rev.7.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">[5300.01]+국가출하승인+신청+민원의+처리+절차(공무원+지침서)_Rev.7.pdf</span></div> <div class="size">0.67MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15218&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767576149064" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="국가출하승인 신청 민원의 처리 절차 등록번호 분야 모바일서비스 Y 고시일 2025-12-30 등록일 2025-12-30 조회수 235 동일 제조번호의 정의 및 민원 처리 절차를 추가하여 개정하였으니, 업무에 참고" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15218&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15218&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15218&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15218&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">국가출하승인 신청 민원의 처리 절차 등록번호 분야 모바일서비스 Y 고시일 2025-12-30 등록일 2025-12-30 조회수 235 동일 제조번호의 정의 및 민원 처리 절차를 추가하여 개정하였으니, 업무에 참고</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/547 https://cnajini.tistory.com/547#entry547comment Tue, 6 Jan 2026 11:22:41 +0900 https://cnajini.tistory.com/546 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품의 품목허가신고 체크리스트 및 세부 업무 매뉴얼</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는<span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span> 의약품의 품목허가신고 업무 관련 &middot; 세부 지침을 정한 것으로서 식품의약품안전처&nbsp;관련&nbsp;부서&nbsp;담당&nbsp;직원의&nbsp;업무처리를&nbsp;위한&nbsp;것입니다.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품의 품목허가신고 체크리스트 및 세부 업무 매뉴얼</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 30일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="570" data-origin-height="777"><span data-url="https://blog.kakaocdn.net/dn/N7El8/dJMcabpkAOT/zqYeYxkZwCdPA842Clcgtk/img.png" data-phocus="https://blog.kakaocdn.net/dn/N7El8/dJMcabpkAOT/zqYeYxkZwCdPA842Clcgtk/img.png"><img src="https://blog.kakaocdn.net/dn/N7El8/dJMcabpkAOT/zqYeYxkZwCdPA842Clcgtk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FN7El8%2FdJMcabpkAOT%2FzqYeYxkZwCdPA842Clcgtk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="570" height="777" data-origin-width="570" data-origin-height="777"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="559" data-origin-height="756"><span data-url="https://blog.kakaocdn.net/dn/1UqKW/dJMcafFhlce/147JoBtjfdYXO9vHN8oz60/img.png" data-phocus="https://blog.kakaocdn.net/dn/1UqKW/dJMcafFhlce/147JoBtjfdYXO9vHN8oz60/img.png"><img src="https://blog.kakaocdn.net/dn/1UqKW/dJMcafFhlce/147JoBtjfdYXO9vHN8oz60/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2F1UqKW%2FdJMcafFhlce%2F147JoBtjfdYXO9vHN8oz60%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="559" height="756" data-origin-width="559" data-origin-height="756"/></span></figure> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="553" data-origin-height="772"><span data-url="https://blog.kakaocdn.net/dn/cN66hy/dJMcaacTsdA/uoY0SZKL8hmbNvjgFvVZVK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cN66hy/dJMcaacTsdA/uoY0SZKL8hmbNvjgFvVZVK/img.png"><img src="https://blog.kakaocdn.net/dn/cN66hy/dJMcaacTsdA/uoY0SZKL8hmbNvjgFvVZVK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcN66hy%2FdJMcaacTsdA%2FuoY0SZKL8hmbNvjgFvVZVK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="553" height="772" data-origin-width="553" data-origin-height="772"/></span></figure> </div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="539" data-origin-height="750"><span data-url="https://blog.kakaocdn.net/dn/cPZq8h/dJMcad1HKXm/iz6je4Rv1qWjQ4Rb5rjif0/img.png" data-phocus="https://blog.kakaocdn.net/dn/cPZq8h/dJMcad1HKXm/iz6je4Rv1qWjQ4Rb5rjif0/img.png"><img src="https://blog.kakaocdn.net/dn/cPZq8h/dJMcad1HKXm/iz6je4Rv1qWjQ4Rb5rjif0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcPZq8h%2FdJMcad1HKXm%2Fiz6je4Rv1qWjQ4Rb5rjif0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="539" height="750" data-origin-width="539" data-origin-height="750"/></span></figure> </div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="556" data-origin-height="777"><span data-url="https://blog.kakaocdn.net/dn/c26Pq5/dJMcac9zvRN/st87YqNv1Nyyy3WpZqNsz1/img.png" data-phocus="https://blog.kakaocdn.net/dn/c26Pq5/dJMcac9zvRN/st87YqNv1Nyyy3WpZqNsz1/img.png"><img src="https://blog.kakaocdn.net/dn/c26Pq5/dJMcac9zvRN/st87YqNv1Nyyy3WpZqNsz1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fc26Pq5%2FdJMcac9zvRN%2Fst87YqNv1Nyyy3WpZqNsz1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="556" height="777" data-origin-width="556" data-origin-height="777"/></span></figure> </div> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">의약품의 품목허가신고 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/kIOSd/dJMcafZzh9R/53mVBl2th7RQ1k5yXeLlLK/%EC%9D%98%EC%95%BD%ED%92%88%EC%9D%98%2B%ED%92%88%EB%AA%A9%ED%97%88%EA%B0%80%2B%EC%8B%A0%EA%B3%A0%2B%EC%B2%B4%ED%81%AC%EB%A6%AC%EC%8A%A4%ED%8A%B8%2B%EB%B0%8F%2B%EC%84%B8%EB%B6%80%2B%EC%97%85%EB%AC%B4%2B%EB%A7%A4%EB%89%B4%EC%96%BC%28%EA%B3%B5%EB%AC%B4%EC%9B%90%2B%EC%A7%80%EC%B9%A8%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">의약품의+품목허가+신고+체크리스트+및+세부+업무+매뉴얼(공무원+지침서).pdf</span></div> <div class="size">10.29MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15217&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767575960044" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품" data-og-description="의약품의 품목허가신고 체크리스트 및 세부 업무 매뉴얼 등록번호 지침서-0901-05 분야 모바일서비스 Y 고시일 등록일 2025-12-30 조회수 438 「의약품의 품목허가&middot;신고 체크리스트 및 세부 업무 매" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15217&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1059/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15217&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15217&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1059/view.do?seq=15217&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;공무원지침서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">의약품의 품목허가신고 체크리스트 및 세부 업무 매뉴얼 등록번호 지침서-0901-05 분야 모바일서비스 Y 고시일 등록일 2025-12-30 조회수 438 「의약품의 품목허가&middot;신고 체크리스트 및 세부 업무 매</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/546 https://cnajini.tistory.com/546#entry546comment Tue, 6 Jan 2026 11:19:42 +0900 https://cnajini.tistory.com/549 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는 생물의약품의 제조방법 변경에 따른 비교동등성 평가에 대하여 알기 쉽게 설명하거나 식품의약품안전평가원의 입장을 기술한 것입니다.</span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 30일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="539" data-origin-height="749"><span data-url="https://blog.kakaocdn.net/dn/bZN2Um/dJMcafZzikA/8DKI41WKx9F1sskBhIQ1P1/img.png" data-phocus="https://blog.kakaocdn.net/dn/bZN2Um/dJMcafZzikA/8DKI41WKx9F1sskBhIQ1P1/img.png"><img src="https://blog.kakaocdn.net/dn/bZN2Um/dJMcafZzikA/8DKI41WKx9F1sskBhIQ1P1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbZN2Um%2FdJMcafZzikA%2F8DKI41WKx9F1sskBhIQ1P1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="539" height="749" data-origin-width="539" data-origin-height="749"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="533" data-origin-height="739"><span data-url="https://blog.kakaocdn.net/dn/bQMcMe/dJMcafSOIAc/i3RsfMCImhk343k5rIcoTK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bQMcMe/dJMcafSOIAc/i3RsfMCImhk343k5rIcoTK/img.png"><img src="https://blog.kakaocdn.net/dn/bQMcMe/dJMcafSOIAc/i3RsfMCImhk343k5rIcoTK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbQMcMe%2FdJMcafSOIAc%2Fi3RsfMCImhk343k5rIcoTK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="533" height="739" data-origin-width="533" data-origin-height="739"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="526" data-origin-height="707"><span data-url="https://blog.kakaocdn.net/dn/bh378I/dJMcahC44JX/hFx1MqFj2TK3NkPkpPZPJK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bh378I/dJMcahC44JX/hFx1MqFj2TK3NkPkpPZPJK/img.png"><img src="https://blog.kakaocdn.net/dn/bh378I/dJMcahC44JX/hFx1MqFj2TK3NkPkpPZPJK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fbh378I%2FdJMcahC44JX%2FhFx1MqFj2TK3NkPkpPZPJK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="526" height="707" data-origin-width="526" data-origin-height="707"/></span></figure> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">생물의약품의 제조방법 변경에 따른 비교동등성 평가 </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bKLuXF/dJMcaaqqIfc/lUSZ4KKQBhD0vvlA4jkqek/%EC%83%9D%EB%AC%BC%EC%9D%98%EC%95%BD%ED%92%88%EC%9D%98_%EC%A0%9C%EC%A1%B0%EB%B0%A9%EB%B2%95_%EB%B3%80%EA%B2%BD%EC%97%90_%EB%94%B0%EB%A5%B8_%EB%B9%84%EA%B5%90%EB%8F%99%EB%93%B1%EC%84%B1_%ED%8F%89%EA%B0%80_%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%28%EB%AF%BC%EC%9B%90%EC%9D%B8%EC%95%88%EB%82%B4%EC%84%9C%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">생물의약품의_제조방법_변경에_따른_비교동등성_평가_가이드라인(민원인안내서).pdf</span></div> <div class="size">0.72MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15806&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767576500431" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품" data-og-description="생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인 생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인 개정 첨부파일 첨부파일 전체 다운로드 --&gt; 생물의약품의_제" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15806&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_1060/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=15806&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15806&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15806&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 | 식품의약품</p> <p class="og-desc" data-ke-size="size16">생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인 생물의약품의 제조방법 변경에 따른 비교동등성 평가 가이드라인 개정 첨부파일 첨부파일 전체 다운로드 --&gt; 생물의약품의_제</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/549 https://cnajini.tistory.com/549#entry549comment Mon, 5 Jan 2026 11:28:44 +0900 https://cnajini.tistory.com/545 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">「대한민국약전」 전부개정고시안 행정예고</span> &nbsp;</span>자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는<span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span> 다음과 같은 내용을 담고 있습니다.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1274" data-origin-height="754"><span data-url="https://blog.kakaocdn.net/dn/cye4Am/dJMcaa41XbI/sbu4yD9xRWqKvfKt55HS71/img.png" data-phocus="https://blog.kakaocdn.net/dn/cye4Am/dJMcaa41XbI/sbu4yD9xRWqKvfKt55HS71/img.png"><img src="https://blog.kakaocdn.net/dn/cye4Am/dJMcaa41XbI/sbu4yD9xRWqKvfKt55HS71/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2Fcye4Am%2FdJMcaa41XbI%2Fsbu4yD9xRWqKvfKt55HS71%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1274" height="754" data-origin-width="1274" data-origin-height="754"/></span></figure> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="1265" data-origin-height="584"><span data-url="https://blog.kakaocdn.net/dn/kWOSH/dJMcaivbBU7/dwS2KhRtsc7dgEIKKroysk/img.png" data-phocus="https://blog.kakaocdn.net/dn/kWOSH/dJMcaivbBU7/dwS2KhRtsc7dgEIKKroysk/img.png"><img src="https://blog.kakaocdn.net/dn/kWOSH/dJMcaivbBU7/dwS2KhRtsc7dgEIKKroysk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FkWOSH%2FdJMcaivbBU7%2FdwS2KhRtsc7dgEIKKroysk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="1265" height="584" data-origin-width="1265" data-origin-height="584"/></span></figure> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;">「대한민국약전」 전부개정고시안 행정예고</span> &nbsp;</span>자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 31일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="544" data-origin-height="707"><span data-url="https://blog.kakaocdn.net/dn/ZL0s2/dJMcadm6dNu/VFbGs7qvT2kN12HvxnmyC1/img.png" data-phocus="https://blog.kakaocdn.net/dn/ZL0s2/dJMcadm6dNu/VFbGs7qvT2kN12HvxnmyC1/img.png"><img src="https://blog.kakaocdn.net/dn/ZL0s2/dJMcadm6dNu/VFbGs7qvT2kN12HvxnmyC1/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FZL0s2%2FdJMcadm6dNu%2FVFbGs7qvT2kN12HvxnmyC1%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="544" height="707" data-origin-width="544" data-origin-height="707"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="color: #333333; letter-spacing: 0px;">구성은 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="295" data-origin-height="177"><span data-url="https://blog.kakaocdn.net/dn/blN8qf/dJMcabpkAy5/5tUSGVayz6GK2T4KaN2U6K/img.png" data-phocus="https://blog.kakaocdn.net/dn/blN8qf/dJMcabpkAy5/5tUSGVayz6GK2T4KaN2U6K/img.png"><img src="https://blog.kakaocdn.net/dn/blN8qf/dJMcabpkAy5/5tUSGVayz6GK2T4KaN2U6K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FblN8qf%2FdJMcabpkAy5%2F5tUSGVayz6GK2T4KaN2U6K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="295" height="177" data-origin-width="295" data-origin-height="177"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span>의약품 품질관리 대한민국약전(KP) 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/czXdv1/dJMcah39N1X/gRZDrMXEuFh6um5lNXuHKK/1.%20%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29_%28%EC%A0%9C2025-538%ED%98%B8%2C%202025.12.31.%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">1. 대한민국약전 전부개정고시(안)_(제2025-538호, 2025.12.31.).pdf</span></div> <div class="size">0.15MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/vTNnn/dJMcahJRIvD/ShkSWolq3nCMKXDcoCym50/%28%EB%B3%84%EC%B2%A8%201%29%20%ED%86%B5%EC%B9%99_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 1) 통칙_전부개정고시(안).pdf</span></div> <div class="size">0.17MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/eiyf77/dJMcahXpCSf/nv4L0FCG0q9i4L62Wxsd11/%28%EB%B3%84%EC%B2%A8%202%29%20%EC%A0%9C%EC%A0%9C%EC%B4%9D%EC%B9%99_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 2) 제제총칙_전부개정고시(안).pdf</span></div> <div class="size">0.26MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/Js7a2/dJMcaaRvmmG/22ID38KqpHT6S6srEKMfTK/%28%EB%B3%84%EC%B2%A8%203%29%20%EC%9D%98%EC%95%BD%ED%92%88%EA%B0%81%EC%A1%B0%20%EC%A0%9C1%EB%B6%80_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 3) 의약품각조 제1부_전부개정고시(안).pdf</span></div> <div class="size">18.69MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/pk31S/dJMcahXpCSE/Z0bKuqoFv0gsbBW0E1pMa0/%28%EB%B3%84%EC%B2%A8%204%29%20%EC%9D%98%EC%95%BD%ED%92%88%EA%B0%81%EC%A1%B0%20%EC%A0%9C2%EB%B6%80_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 4) 의약품각조 제2부_전부개정고시(안).pdf</span></div> <div class="size">3.62MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bSh12b/dJMcahXpCST/3u1d1CoAQBwsuFHvYxnV0k/%28%EB%B3%84%EC%B2%A8%205%29%20%EC%9D%BC%EB%B0%98%EC%8B%9C%ED%97%98%EB%B2%95_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 5) 일반시험법_전부개정고시(안).pdf</span></div> <div class="size">5.43MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/qmni8/dJMb9957ZPG/P5qZFNeZW8m7HmCQZKGV61/%28%EB%B3%84%EC%B2%A8%206%29%20%EC%9D%BC%EB%B0%98%EC%A0%95%EB%B3%B4_%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(별첨 6) 일반정보_전부개정고시(안).pdf</span></div> <div class="size">4.07MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/KtJWO/dJMcaior7zU/OXy3VwuAplgPL2Y8Zrrp20/%28%EC%B0%B8%EA%B3%A0%201%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%201%5D%20%ED%86%B5%EC%B9%99.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 1)대한민국약전 전부개정고시(안) 변경대비표_[별표 1] 통칙.pdf</span></div> <div class="size">0.20MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/DnGXx/dJMcaior7z9/hfLcQkHBknYs12dxEAWUD1/%28%EC%B0%B8%EA%B3%A0%202%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%202%5D%20%EC%A0%9C%EC%A0%9C%EC%B4%9D%EC%B9%99.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 2)대한민국약전 전부개정고시(안) 변경대비표_[별표 2] 제제총칙.pdf</span></div> <div class="size">0.40MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/y6OfD/dJMcaior7Ah/v8BPlP3HypXPNC8CyJn9Nk/%28%EC%B0%B8%EA%B3%A0%203%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%203%5D%20%EC%9D%98%EC%95%BD%ED%92%88%EA%B0%81%EC%A1%B0%20%EC%A0%9C1%EB%B6%80.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 3)대한민국약전 전부개정고시(안) 변경대비표_[별표 3] 의약품각조 제1부.pdf</span></div> <div class="size">0.31MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/CPBuq/dJMb99LOCia/UoQPltUT3pi2jHj0bO0ByK/%28%EC%B0%B8%EA%B3%A0%204%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%204%5D%20%EC%9D%98%EC%95%BD%ED%92%88%EA%B0%81%EC%A1%B0%20%EC%A0%9C2%EB%B6%80.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 4)대한민국약전 전부개정고시(안) 변경대비표_[별표 4] 의약품각조 제2부.pdf</span></div> <div class="size">0.19MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/UBPEv/dJMcab3WrzT/uLCci6E6L14S3DkwZff8QK/%28%EC%B0%B8%EA%B3%A0%205%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%205%5D%20%EC%9D%BC%EB%B0%98%EC%8B%9C%ED%97%98%EB%B2%95.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 5)대한민국약전 전부개정고시(안) 변경대비표_[별표 5] 일반시험법.pdf</span></div> <div class="size">1.74MB</div> </div> </a></figure> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/bp9gkI/dJMb99LOCkA/KSg8VcihKVXf6zV0NPullK/%28%EC%B0%B8%EA%B3%A0%206%29%EB%8C%80%ED%95%9C%EB%AF%BC%EA%B5%AD%EC%95%BD%EC%A0%84%20%EC%A0%84%EB%B6%80%EA%B0%9C%EC%A0%95%EA%B3%A0%EC%8B%9C%28%EC%95%88%29%20%EB%B3%80%EA%B2%BD%EB%8C%80%EB%B9%84%ED%91%9C_%5B%EB%B3%84%ED%91%9C%206%5D%20%EC%9D%BC%EB%B0%98%EC%A0%95%EB%B3%B4.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">(참고 6)대한민국약전 전부개정고시(안) 변경대비표_[별표 6] 일반정보.pdf</span></div> <div class="size">0.99MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_209/view.do?seq=44199&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 - 상세보기 | 식품의약품안전처</a></p> <figure id="og_1767575466223" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 | 식품의약품안전처" data-og-description="「대한민국약전」 전부개정고시안 행정예고 등록일 2025-12-31 조회수 1047 식품의약품안전처 공고 제2025 - 538호 「약사법」제51조제1항에 따른 「대한민국약전」(식품의약품안전처 고시 제2025-18호" data-og-host="www.mfds.go.kr" data-og-source-url="https://www.mfds.go.kr/brd/m_209/view.do?seq=44199&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" data-og-url="https://www.mfds.go.kr/brd/m_209/view.do?company_cd=&amp;company_nm=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;page=1&amp;seq=44199&amp;srchFr=&amp;srchTo=&amp;srchTp=&amp;srchWord=" data-og-image=""><a href="https://www.mfds.go.kr/brd/m_209/view.do?seq=44199&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1" target="_blank" rel="noopener" data-source-url="https://www.mfds.go.kr/brd/m_209/view.do?seq=44199&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1"> <div class="og-image" style="background-image: url();">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;입법/행정예고 | 식품의약품안전처</p> <p class="og-desc" data-ke-size="size16">「대한민국약전」 전부개정고시안 행정예고 등록일 2025-12-31 조회수 1047 식품의약품안전처 공고 제2025 - 538호 「약사법」제51조제1항에 따른 「대한민국약전」(식품의약품안전처 고시 제2025-18호</p> <p class="og-host" data-ke-size="size16">www.mfds.go.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> </div> 품질관리(QC)/공정서 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/545 https://cnajini.tistory.com/545#entry545comment Mon, 5 Jan 2026 10:11:26 +0900 https://cnajini.tistory.com/544 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>「2025 바이오의약품 산업동향 보고서」 (2025.12) 발간 안내 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는<span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span>&nbsp;</span>다음과 같은 내용을 기술한 것입니다.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="711" data-origin-height="611"><span data-url="https://blog.kakaocdn.net/dn/bthCnW/dJMcaajCThu/NaMX1i49IY47OLjrnLlEBK/img.png" data-phocus="https://blog.kakaocdn.net/dn/bthCnW/dJMcaajCThu/NaMX1i49IY47OLjrnLlEBK/img.png"><img src="https://blog.kakaocdn.net/dn/bthCnW/dJMcaajCThu/NaMX1i49IY47OLjrnLlEBK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbthCnW%2FdJMcaajCThu%2FNaMX1i49IY47OLjrnLlEBK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="711" height="611" data-origin-width="711" data-origin-height="611"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span>「2025 바이오의약품 산업동향 보고서」 (2025.12) 발간 안내 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 29일' 자로 한국바이오의약품협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="589" data-origin-height="824"><span data-url="https://blog.kakaocdn.net/dn/bO1zky/dJMcabCPcjh/GbE2wVEW1ObvkD6cVKi9hk/img.png" data-phocus="https://blog.kakaocdn.net/dn/bO1zky/dJMcabCPcjh/GbE2wVEW1ObvkD6cVKi9hk/img.png"><img src="https://blog.kakaocdn.net/dn/bO1zky/dJMcabCPcjh/GbE2wVEW1ObvkD6cVKi9hk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FbO1zky%2FdJMcabCPcjh%2FGbE2wVEW1ObvkD6cVKi9hk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="589" height="824" data-origin-width="589" data-origin-height="824"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="557" data-origin-height="772"><span data-url="https://blog.kakaocdn.net/dn/coJdLI/dJMcabQmxua/Bs3IRQKu1rkG3uYRI0H3kk/img.png" data-phocus="https://blog.kakaocdn.net/dn/coJdLI/dJMcabQmxua/Bs3IRQKu1rkG3uYRI0H3kk/img.png"><img src="https://blog.kakaocdn.net/dn/coJdLI/dJMcabQmxua/Bs3IRQKu1rkG3uYRI0H3kk/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcoJdLI%2FdJMcabQmxua%2FBs3IRQKu1rkG3uYRI0H3kk%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="557" height="772" data-origin-width="557" data-origin-height="772"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span> <span style="background-color: #ffffff; color: #333333; text-align: left;">바이오의약품 산업동향</span> 관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/zpsPD/dJMcafSL2TP/FFjxPK5fmn9f08FUbDPIf0/%5BKoBIA%5D%202025%20%EB%B0%94%EC%9D%B4%EC%98%A4%EC%9D%98%EC%95%BD%ED%92%88%20%EC%82%B0%EC%97%85%EB%8F%99%ED%96%A5%20%EB%B3%B4%EA%B3%A0%EC%84%9C%20%28%EC%B5%9C%EC%A2%85%29%20%282025.12%20%EB%B0%9C%EA%B0%84%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">[KoBIA] 2025 바이오의약품 산업동향 보고서 (최종) (2025.12 발간).pdf</span></div> <div class="size">3.81MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kobia.kr/bbs/board.php?tbl=notice&amp;mode=VIEW&amp;num=1251&amp;">한국바이오의약품협회 - 홈페이지</a></p> <figure id="og_1766970701190" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국바이오의약품협회" data-og-description="한국바이오의약품협회는 보건의료산업 진흥과 국민보건 향상에 기여합니다." data-og-host="www.kobia.kr" data-og-source-url="https://www.kobia.kr/bbs/board.php?tbl=notice&amp;mode=VIEW&amp;num=1251&amp;" data-og-url="https://www.kobia.kr" data-og-image="https://scrap.kakaocdn.net/dn/b6SGjW/hyZQumvAJq/1hZ9RVOIubhSb1lydWoTT1/img.jpg?width=800&amp;height=800&amp;face=0_0_800_800"><a href="https://www.kobia.kr/bbs/board.php?tbl=notice&amp;mode=VIEW&amp;num=1251&amp;" target="_blank" rel="noopener" data-source-url="https://www.kobia.kr/bbs/board.php?tbl=notice&amp;mode=VIEW&amp;num=1251&amp;"> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/b6SGjW/hyZQumvAJq/1hZ9RVOIubhSb1lydWoTT1/img.jpg?width=800&amp;height=800&amp;face=0_0_800_800');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국바이오의약품협회</p> <p class="og-desc" data-ke-size="size16">한국바이오의약품협회는 보건의료산업 진흥과 국민보건 향상에 기여합니다.</p> <p class="og-host" data-ke-size="size16">www.kobia.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/544 https://cnajini.tistory.com/544#entry544comment Fri, 2 Jan 2026 11:12:02 +0900 https://cnajini.tistory.com/543 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span>오염관리전략(CCS, Contamination Control Strategy) 작성 양식 배포 알림 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는<span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span> 「국제적 GMP 규정 동향분석 기반 제조&middot;품질관리 규제조화 이행방안 연구(연구기관: 한국제약바이오협회)」과 관련하여 무균의약품 제조소의 오염관리전략(CCS, Contamination Control Stategy) 문서화를 지원하기 위해 본 작성양식을&nbsp;마련하였습니다.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #ffffff; color: #333333; text-align: left;">오염관리전략(CCS, Contamination Control Strategy) 작성 양식 배포 알림</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 22일' 자로 한국제약바이오협회의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="562" data-origin-height="740"><span data-url="https://blog.kakaocdn.net/dn/YFnXZ/dJMcaiaTmpd/PLrQh5UvrrxXFItSV8BKjK/img.png" data-phocus="https://blog.kakaocdn.net/dn/YFnXZ/dJMcaiaTmpd/PLrQh5UvrrxXFItSV8BKjK/img.png"><img src="https://blog.kakaocdn.net/dn/YFnXZ/dJMcaiaTmpd/PLrQh5UvrrxXFItSV8BKjK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FYFnXZ%2FdJMcaiaTmpd%2FPLrQh5UvrrxXFItSV8BKjK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="562" height="740" data-origin-width="562" data-origin-height="740"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">​</p> </div> </div> </div> </div> <p data-ke-size="size16">&nbsp;</p> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span><span style="color: #333333; letter-spacing: 0px;">목차는 다음과 같습니다.</span></p> </div> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="535" data-origin-height="472"><span data-url="https://blog.kakaocdn.net/dn/eBg8Y4/dJMcaaDVf47/z2riU2o3scW1tYXXqfroW0/img.png" data-phocus="https://blog.kakaocdn.net/dn/eBg8Y4/dJMcaaDVf47/z2riU2o3scW1tYXXqfroW0/img.png"><img src="https://blog.kakaocdn.net/dn/eBg8Y4/dJMcaaDVf47/z2riU2o3scW1tYXXqfroW0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FeBg8Y4%2FdJMcaaDVf47%2Fz2riU2o3scW1tYXXqfroW0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="535" height="472" data-origin-width="535" data-origin-height="472"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"> <span style="background-color: #ffffff; color: #333333; text-align: left;">오염관리전략(CCS, Contamination Control Strategy)</span> </span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> </div> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/v1SfW/dJMcag5dSGc/Ne007yKbwacvYPgAOiuWtK/%ED%95%9C%EA%B5%AD%EC%A0%9C%EC%95%BD%EB%B0%94%EC%9D%B4%EC%98%A4%ED%98%91%ED%9A%8C_%EC%98%A4%EC%97%BC%EA%B4%80%EB%A6%AC%EC%A0%84%EB%9E%B5%28CCS%2C_Contamination_Control_Strategy%29_%EC%9E%91%EC%84%B1_%EC%96%91%EC%8B%9D_%EB%B0%B0%ED%8F%AC_%EC%95%8C%EB%A6%BC.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">한국제약바이오협회_오염관리전략(CCS,_Contamination_Control_Strategy)_작성_양식_배포_알림.pdf</span></div> <div class="size">0.31MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p><figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/zQpvb/dJMcag5dSGh/ktYeNX8AKAflyyKl6W2PFk/%EC%98%A4%EC%97%BC%EA%B4%80%EB%A6%AC%EC%A0%84%EB%9E%B5%28CCS%2C_Contamination_Control_Strategy%29_%EC%9E%91%EC%84%B1_%EC%96%91%EC%8B%9D%2825.12.%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">오염관리전략(CCS,_Contamination_Control_Strategy)_작성_양식(25.12.).pdf</span></div> <div class="size">0.28MB</div> </div> </a></figure> </p> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248730?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=">공지사항 &middot; 한국제약바이오협회</a></p> <figure id="og_1766970402387" contenteditable="false" data-ke-type="opengraph" data-ke-align="alignCenter" data-og-type="website" data-og-title="한국제약바이오협회" data-og-description="KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의 " data-og-host="www.kpbma.or.kr" data-og-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248730?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" data-og-url="http://kpbma.or.kr/" data-og-image="https://scrap.kakaocdn.net/dn/Wq8yG/hyZQufJWFG/cfuQyMDF2SU7Sksc2KcxyK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/cMk2mS/hyZQr4l6jW/mVgogmJjQrAgiMvZnASXl0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/cdxgmq/hyZQwLm3ca/3r5OFHMt1kQB4gtD91Y6t1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080"><a href="https://www.kpbma.or.kr/info/notice/notice/select/248730?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name=" target="_blank" rel="noopener" data-source-url="https://www.kpbma.or.kr/info/notice/notice/select/248730?start=0&amp;search_txt=&amp;b_subject=&amp;startDate=&amp;endDate=&amp;b_content=&amp;b_m_name="> <div class="og-image" style="background-image: url('https://scrap.kakaocdn.net/dn/Wq8yG/hyZQufJWFG/cfuQyMDF2SU7Sksc2KcxyK/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/cMk2mS/hyZQr4l6jW/mVgogmJjQrAgiMvZnASXl0/img.jpg?width=800&amp;height=400&amp;face=0_0_800_400,https://scrap.kakaocdn.net/dn/cdxgmq/hyZQwLm3ca/3r5OFHMt1kQB4gtD91Y6t1/img.jpg?width=1920&amp;height=1080&amp;face=0_0_1920_1080');">&nbsp;</div> <div class="og-text"> <p class="og-title" data-ke-size="size16">한국제약바이오협회</p> <p class="og-desc" data-ke-size="size16">KPBMA's Top 10 --&gt; KPBMA's Top --&gt; 협회 발간물 제약바이오협회 온라인 도서관을 이용한 방문객들이 가장 많이 찾은 도서 목록입니다 --&gt; 온라인 도서관에서 제공되는 제약바이오협회의 정기간행물의</p> <p class="og-host" data-ke-size="size16">www.kpbma.or.kr</p> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/543 https://cnajini.tistory.com/543#entry543comment Fri, 2 Jan 2026 11:06:55 +0900 https://cnajini.tistory.com/542 <div id="SE-9baf8c34-0ac9-4211-8973-2073b4e9f2c1" style="background-color: #ffffff; color: #333333; text-align: left;"> <div> <div> <div> <p id="SE-0aa692c0-b720-4646-9470-62acaafeb87d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">안녕하세요. 별구 입니다.​</span></p> <p id="SE-f93c1a5c-c48f-47ec-9660-30513f4c3e99" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​​​​​​​​​​​​​​​​</span></p> <p id="SE-3522c084-3e57-47ed-8c0e-edfb411ff1a8" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;"><span><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품 (변경)등록 및 연계심사 가이드라인(종전 완제의약품 중심 허가&middot;심사 운영 관리 방안 관련 질의응답집)</span> 자료가</span></span><span>&nbsp;</span></span>공개 되었습니다.</span></p> <p id="SE-731d6c51-6484-414b-89f8-62477295a02a" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-29aad326-f6d5-48c2-9091-ba03081eec3c" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">이 문서는<span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span> &lsquo;원료-완제의약품 연계심사&rsquo;를 시행함에 따라 원료의약품 (변경)등록 업무를 포함하여 품질 평가 시 필요서류 및 변경관리 유형에 대하여 알기 쉽게 설명하거나 식품의약품안전처의 </span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span><span>입장을&nbsp;기술한&nbsp;것입니다.</span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></p> <p id="SE-bc88fa4e-bfd2-48f4-97eb-e277ddab19c0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #000000;"><span><span> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품 (변경)등록 및 연계심사 가이드라인(종전 완제의약품 중심 허가&middot;심사 운영 관리 방안 관련 질의응답집)</span> 자료는<span>&nbsp;</span></span></span></span><span style="background-color: #ffffff; color: #333333;"><span>&nbsp;</span>'2025년 12월 26일' 자로 식품의약품안전처의 홈페이지에 게시 되었습니다.</span></p> <p id="SE-9a70e213-3aa1-408f-b46c-1eb475abf960" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​</span></p> <p id="SE-909a2146-cf0c-4d11-bce3-3d8c7c8cf664" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 내용은 다음과 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="532" data-origin-height="776"><span data-url="https://blog.kakaocdn.net/dn/cOPDiD/dJMcabv4k5J/UQXuKmJS1O99TX6JshiwBK/img.png" data-phocus="https://blog.kakaocdn.net/dn/cOPDiD/dJMcabv4k5J/UQXuKmJS1O99TX6JshiwBK/img.png"><img src="https://blog.kakaocdn.net/dn/cOPDiD/dJMcabv4k5J/UQXuKmJS1O99TX6JshiwBK/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FcOPDiD%2FdJMcabv4k5J%2FUQXuKmJS1O99TX6JshiwBK%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="532" height="776" data-origin-width="532" data-origin-height="776"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span>​</p> </div> </div> </div> </div> <div id="SE-1c1f83db-e63e-4a55-95da-0467554c9a0c" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">그 제개정은 다음과 같습니다.</span></p> <p id="SE-89d37116-2652-43c1-bb4b-29d18186950d" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​​</span></p> </div> <p style="color: #222222; text-align: start;" data-ke-size="size16"><span style="background-color: #ffffff;">​</span></p> <p><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="566" data-origin-height="475"><span data-url="https://blog.kakaocdn.net/dn/rAhQG/dJMcahwhlPo/iBbIk2ifwj4HoUHKjjf44k/img.png" data-phocus="https://blog.kakaocdn.net/dn/rAhQG/dJMcahwhlPo/iBbIk2ifwj4HoUHKjjf44k/img.png"><img src="https://blog.kakaocdn.net/dn/rAhQG/dJMcahwhlPo/iBbIk2ifwj4HoUHKjjf44k/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FrAhQG%2FdJMcahwhlPo%2FiBbIk2ifwj4HoUHKjjf44k%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="566" height="475" data-origin-width="566" data-origin-height="475"/></span></figure> </p> <p style="color: #222222; text-align: start;" data-ke-size="size16">&nbsp;</p> <div id="SE-f311e0cd-ac42-496c-b09a-3c13abe6581f" style="background-color: #ffffff; color: #333333; text-align: left;"> <p id="SE-e03c0afe-5789-4a04-8b83-bcdb2ccd4632" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">목차는 다음과 같습니다.</span></p> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;">&nbsp;</div> <div style="text-align: center;"><figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="523" data-origin-height="752"><span data-url="https://blog.kakaocdn.net/dn/XRZa0/dJMcahwhlPE/RaX6SgUurBt0PV90a4hfE0/img.png" data-phocus="https://blog.kakaocdn.net/dn/XRZa0/dJMcahwhlPE/RaX6SgUurBt0PV90a4hfE0/img.png"><img src="https://blog.kakaocdn.net/dn/XRZa0/dJMcahwhlPE/RaX6SgUurBt0PV90a4hfE0/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FXRZa0%2FdJMcahwhlPE%2FRaX6SgUurBt0PV90a4hfE0%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="523" height="752" data-origin-width="523" data-origin-height="752"/></span></figure> </div> <p style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​​​​</span></p> <figure class="imageblock alignCenter" data-ke-mobileStyle="widthOrigin" data-origin-width="533" data-origin-height="534"><span data-url="https://blog.kakaocdn.net/dn/tsMj3/dJMcahwhlPT/z2fiTWXpEmDrk1UFhLqK8K/img.png" data-phocus="https://blog.kakaocdn.net/dn/tsMj3/dJMcahwhlPT/z2fiTWXpEmDrk1UFhLqK8K/img.png"><img src="https://blog.kakaocdn.net/dn/tsMj3/dJMcahwhlPT/z2fiTWXpEmDrk1UFhLqK8K/img.png" srcset="https://img1.daumcdn.net/thumb/R1280x0/?scode=mtistory2&fname=https%3A%2F%2Fblog.kakaocdn.net%2Fdn%2FtsMj3%2FdJMcahwhlPT%2Fz2fiTWXpEmDrk1UFhLqK8K%2Fimg.png" onerror="this.onerror=null; this.src='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png'; this.srcset='//t1.daumcdn.net/tistory_admin/static/images/no-image-v1.png';" loading="lazy" width="533" height="534" data-origin-width="533" data-origin-height="534"/></span></figure> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <p id="SE-aa148e40-0068-43c4-935e-9a1b3a6b51a0" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">자세한 사항은 첨부자료 확인 부탁드립니다.</span></p> <div style="text-align: center;">&nbsp;</div> <p id="SE-2ad866f7-79cc-44fb-9bfe-d0c99609aa95" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #ffffff; color: #333333;">​</span></p> <p id="SE-3e30bdd5-9ecc-4efd-94c6-19a2762a474b" style="color: #222222; text-align: left;" data-ke-size="size16"><span style="background-color: #f8f8f8; color: #333333;"><span style="background-color: #f8f8f8; color: #000000; text-align: left;"><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"><span><span><span><span style="background-color: #f8f8f8; color: #333333; text-align: start;"> <span style="background-color: #f8f8f8; color: #333333; text-align: start;">원료의약품 (변경)등록 및 연계심사 </span></span>관련 진행 시</span></span></span></span></span></span></span><span>&nbsp;</span></span><span style="background-color: #ffffff; color: #333333;">참고자료로 활용하면 좋을 것 같습니다.</span></p> <p style="color: #222222; text-align: left;" data-ke-size="size16">&nbsp;</p> <figure class="fileblock" data-ke-align="alignCenter"><a href="https://blog.kakaocdn.net/dn/d03Kgj/dJMcaaqobhs/iLjO6knlI0PKQqAvoJEGGk/%EC%9B%90%EB%A3%8C%EC%9D%98%EC%95%BD%ED%92%88%2B%28%EB%B3%80%EA%B2%BD%29%EB%93%B1%EB%A1%9D%2B%EB%B0%8F%2B%EC%97%B0%EA%B3%84%EC%8B%AC%EC%82%AC%2B%EA%B0%80%EC%9D%B4%EB%93%9C%EB%9D%BC%EC%9D%B8%2B%EA%B0%9C%EC%A0%95%28%EC%B5%9C%EC%A2%85%29.pdf?attach=1&amp;knm=tfile.pdf" class=""> <div class="image"></div> <div class="desc"><div class="filename"><span class="name">원료의약품+(변경)등록+및+연계심사+가이드라인+개정(최종).pdf</span></div> <div class="size">1.51MB</div> </div> </a></figure> <p data-ke-size="size16">&nbsp;</p> <p data-ke-size="size16"><a href="https://www.mfds.go.kr/brd/m_1060/view.do?seq=15802&amp;srchFr=&amp;srchTo=&amp;srchWord=&amp;srchTp=&amp;itm_seq_1=0&amp;itm_seq_2=0&amp;multi_itm_seq=0&amp;company_cd=&amp;company_nm=&amp;page=1">식품의약품안전처&gt;법령/자료&gt;법령정보&gt;공무원지침서/민원인안내서&gt;민원인안내서 - 상세보기 | 식품의약품안전처</a></p> <p data-ke-size="size16">&nbsp;</p> </div> 품질보증(QA)/안내서_지침서 등 Data Integrity 공정서 백신 생물학 생약 약전 의약품 임상 추출물 한약 빛별구 https://cnajini.tistory.com/542 https://cnajini.tistory.com/542#entry542comment Thu, 1 Jan 2026 11:01:11 +0900