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'의약품 제조 및 품질관리에 관한 규정' 일부개정 고시 알림

'의약품 제조 및 품질관리에 관한 규정' 일부개정 고시 알림 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2021-11-08	조회수	3,301
국가정보
출처	식품의약품안전처
원문	https://www.mfds.go.kr/brd/m_207/view.do?seq=14711&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1
첨부파일	전문_의약품+제조+및+품질관리기준.hwp(26.5KB)내려받기

한국보건산업진흥원에서 안내드립니다.

<식품의약품안전처 「의약품 제조 및 품질관리에 관한 규정」 일부개정 >

의약품실사상호협력기구(PIC/S) 가입국으로서 실시간 출하 관련 의약품 제조 및 품질관리기준(GMP)을 국제조화하고, GMP 적용 제외대상 의료용 고압가스의 종류를 명확히 하고자 「의약품 제조 및 품질관리에 관한 규정」을 '21.11.5자로 개정·고시하였음을 알려드립니다.

동 개정고시는 식품의약품안전처 홈페이지(www.mfds.go.kr > 법령/자료 > 법령 정보 > 제·개정고시등)에서 확인하실 수 있습니다.

이전글 「의약품동등성시험기준」 일부개정고시
다음글 '바이오의약품 전문수탁 제조업체 GMP 평가절차[공무원지침서]' 개정 알림

<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">한국보건산업진흥원</span><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">에서 안내드립니다.</span></p>
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br></p>
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 14pt; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;"><식품의약품안전처 </span><span style="color: rgb(81, 143, 187); box-sizing: inherit; text-size-adjust: none;">「의약품 제조 및 품질관리에 관한 규정」 일부개정 </span><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;">></span></span></strong></span></p>
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p>
<p style="margin: 0px; padding: 0px; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); font-family: tahoma; box-sizing: inherit; text-size-adjust: none;"><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">의약품실사상호협력기구(PIC/S) 가입국으로서 실시간 출하 관련 의약품 제조 및 품질관리기준(GMP)을 국제조화하고, GMP 적용 제외대상 의료용 고압가스의 종류를 명확히 하고자 「의약품 제조 및 품질관리에 관한 규정」을 '21.11.5자로 개정·고시하였음을 알려드립니다. </span></span></p>
<p style="margin: 0px; padding: 0px; font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></span></p>
<p style="margin: 0px; padding: 0px; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); font-family: tahoma; box-sizing: inherit; text-size-adjust: none;"><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">동 개정고시는 식품의약품안전처 홈페이지(<a style="border: 0px currentColor; border-image: none; color: rgb(125, 125, 125); text-decoration: none; box-sizing: inherit; text-size-adjust: none;" href="http://www.mfds.go.kr/">www.mfds.go.kr</a> > 법령/자료 > 법령 정보 > 제</span></span><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 16px; box-sizing: inherit; text-size-adjust: none;">·개정고시등</span><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">)에서 확인하실 수 있습니다.<br style="box-sizing: inherit; text-size-adjust: none;"></span></p>

<p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">한국보건산업진흥원</span><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">에서 안내드립니다.</span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><span style="font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 14pt; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;"><식품의약품안전처 </span><span style="color: rgb(81, 143, 187); box-sizing: inherit; text-size-adjust: none;">「의약품 제조 및 품질관리에 관한 규정」 일부개정 </span><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;">></span></span></strong></span></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p style="margin: 0px; padding: 0px; color: rgb(125, 125, 125); text-transform: none; text-indent: 0px; letter-spacing: normal; font-family: 'Nanum Gothic'; font-size: 13px; font-style: normal; font-weight: 400; word-spacing: 0px; white-space: normal; box-sizing: inherit; orphans: 2; widows: 2; background-color: rgb(255, 255, 255); text-size-adjust: none; font-variant-ligatures: normal; font-variant-caps: normal; -webkit-text-stroke-width: 0px; text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;" 255,="" rgb(255,="" 13px;="" nanum=""><br style="box-sizing: inherit; text-size-adjust: none;"></p> <p style="margin: 0px; padding: 0px; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); font-family: tahoma; box-sizing: inherit; text-size-adjust: none;"><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">의약품실사상호협력기구(PIC/S) 가입국으로서 실시간 출하 관련 의약품 제조 및 품질관리기준(GMP)을 국제조화하고, GMP 적용 제외대상 의료용 고압가스의 종류를 명확히 하고자 「의약품 제조 및 품질관리에 관한 규정」을 '21.11.5자로 개정·고시하였음을 알려드립니다. </span></span></p> <p style="margin: 0px; padding: 0px; font-family: tahoma; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 11pt; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); box-sizing: inherit; text-size-adjust: none;"><span style="font-size: 12pt; box-sizing: inherit; text-size-adjust: none;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></span></p> <p style="margin: 0px; padding: 0px; box-sizing: inherit; text-size-adjust: none;"><span style="color: rgb(125, 125, 125); font-family: tahoma; box-sizing: inherit; text-size-adjust: none;"><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">동 개정고시는 식품의약품안전처 홈페이지(<a style="border: 0px currentColor; border-image: none; color: rgb(125, 125, 125); text-decoration: none; box-sizing: inherit; text-size-adjust: none;" href="http://www.mfds.go.kr/">www.mfds.go.kr</a> > 법령/자료 > 법령 정보 > 제</span></span><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 16px; box-sizing: inherit; text-size-adjust: none;">·개정고시등</span><span style="font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 12pt; box-sizing: inherit; text-size-adjust: none;">)에서 확인하실 수 있습니다.<br style="box-sizing: inherit; text-size-adjust: none;"></span></p>
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