바로가기 및 건너띄기 링크: 본문 바로가기; 주메뉴 바로가기

글로벌제약산업정보

의약품 인허가 개요

바이오의약품 사전 GMP 평가 지침 개정

바이오의약품 사전 GMP 평가 지침 개정 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2021-12-28	조회수	1,538
국가정보	아시아>대한민국
출처	식품의약품안전처
원문	https://www.mfds.go.kr/brd/m_1059/view.do?seq=14873&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
첨부파일	바이오의약품+사전+GMP+평가+지침.pdf(1.51MB)내려받기

바이오의약품 허가신청 시 제조 및 품질관리기준(GMP) 실시상황 평가 절차와 관련하여 현재 운영 중인 업무처리 절차 및 평가대상을 명확하게 하기 위하여 붙임과 같이 '바이오의약품 사전 GMP 평가 지침(공무원지침서)'을 개정하였음을 알려드리니 업무에 참고하시기 바랍니다.

※ 참고

○ 개정일 : 2021.12.14.

○ 시행일 : 2022.1.1.

이전글 해외 인허가 현황 (2021/12/20 ~ 2021/12/26)
다음글 The Drug and Health Product Registered in Canada

<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">바이오의약품 허가신청 시 제조 및 품질관리기준(GMP) 실시상황 평가 절차와 관련하여 현재 운영 중인 업무처리 절차 및 평가대상을 명확하게 하기 위하여 붙임과 같이 '바이오의약품 사전 GMP 평가 지침(공무원지침서)'을 개정하였음을 알려드리니 업무에 참고하시기 바랍니다.
<br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">
<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> 
<br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">
<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">※ 참고
<br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">
<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">○ 개정일 : 2021.12.14.
<br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">
<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">○ 시행일 : 2022.1.1.

<p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">바이오의약품 허가신청 시 제조 및 품질관리기준(GMP) 실시상황 평가 절차와 관련하여 현재 운영 중인 업무처리 절차 및 평가대상을 명확하게 하기 위하여 붙임과 같이 '바이오의약품 사전 GMP 평가 지침(공무원지침서)'을 개정하였음을 알려드리니 업무에 참고하시기 바랍니다. <br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> <p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> <br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> <p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">※ 참고 <br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> <p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">○ 개정일 : 2021.12.14. <br style="color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;"> <p style="margin: 0px; padding: 0px; border: currentColor; border-image: none; color: rgb(102, 102, 102); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic', 나눔고딕, NanumGothic, '맑은 고딕', 'Malgun Gothic', 돋움, Dotum, sans-serif; font-size: 15px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-decoration-color: initial; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial;">○ 시행일 : 2022.1.1. 
소스입니다. Ctrl+C를 눌러 클립보드로 복사하세요

제약산업정보포털

인기검색어 TOP 10

전체메뉴

글로벌제약산업정보

의약품 인허가 개요

바이오의약품 사전 GMP 평가 지침 개정

관련기관 배너모음