{"id":2307,"date":"2024-08-29T16:57:10","date_gmt":"2024-08-29T08:57:10","guid":{"rendered":"http:\/\/www.csw-vn.cn\/?p=2307"},"modified":"2024-08-29T16:57:10","modified_gmt":"2024-08-29T08:57:10","slug":"fda%e8%ae%a4%e8%af%81%e4%bb%8b%e7%bb%8d%ef%bc%8cfda%e8%ae%a4%e8%af%81%e6%9d%a1%e4%bb%b6%e3%80%81fda%e8%ae%a4%e8%af%81%e6%b5%81%e7%a8%8b%e5%8f%8a%e6%b3%a8%e6%84%8f%e4%ba%8b%e9%a1%b9","status":"publish","type":"post","link":"http:\/\/www.csw-vn.cn\/vi\/2307.html","title":{"rendered":"Gi\u1edbi thi\u1ec7u v\u1ec1 ch\u1ee9ng nh\u1eadn FDA, \u0111i\u1ec1u ki\u1ec7n ch\u1ee9ng nh\u1eadn FDA, quy tr\u00ecnh ch\u1ee9ng nh\u1eadn FDA v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p ph\u00f2ng ng\u1eeba"},"content":{"rendered":"
        Gi\u1edbi thi\u1ec7u v\u1ec1 Ch\u1ee9ng nh\u1eadn FDA<\/strong>\n        Khi ch\u1ee9ng nh\u1eadn c\u1ee7a FDA l\u00e0 m\u1ed9t l\u0129nh v\u1ef1c ph\u1ee9c t\u1ea1p v\u00e0 quan tr\u1ecdng, ch\u00fang ta ph\u1ea3i \u0111i s\u00e2u v\u00e0o b\u1ed1i c\u1ea3nh l\u1ecbch s\u1eed, quy tr\u00ecnh ch\u1ee9ng nh\u1eadn, t\u1ea7m quan tr\u1ecdng v\u00e0 t\u00e1c \u0111\u1ed9ng s\u00e2u r\u1ed9ng c\u1ee7a n\u00f3 \u0111\u1ed1i v\u1edbi ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m v\u00e0 th\u1ef1c ph\u1ea9m to\u00e0n c\u1ea7u. L\u00e0 m\u1ed9t trong nh\u1eefng c\u01a1 quan qu\u1ea3n l\u00fd th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m c\u00f3 th\u1ea9m quy\u1ec1n nh\u1ea5t tr\u00ean th\u1ebf gi\u1edbi, ch\u1ee9ng nh\u1eadn c\u1ee7a FDA kh\u00f4ng ch\u1ec9 l\u00e0 s\u1ef1 ki\u1ec3m so\u00e1t ch\u1eb7t ch\u1ebd v\u1ec1 an to\u00e0n v\u00e0 hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m m\u00e0 c\u00f2n l\u00e0 s\u1ef1 \u0111\u1ea3m b\u1ea3o v\u1eefng ch\u1eafc v\u1ec1 ni\u1ec1m tin v\u00e0 s\u1ee9c kh\u1ecfe c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng. \n        Vi\u1ec7c th\u00e0nh l\u1eadp FDA b\u1eaft \u0111\u1ea7u t\u1eeb n\u0103m 1906, khi Qu\u1ed1c h\u1ed9i Hoa K\u1ef3 th\u00f4ng qua \u0110\u1ea1o lu\u1eadt Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Nguy\u00ean ch\u1ea5t, \u0111\u00e1nh d\u1ea5u s\u1ef1 can thi\u1ec7p ch\u00ednh th\u1ee9c c\u1ee7a ch\u00ednh ph\u1ee7 v\u00e0o quy \u0111\u1ecbnh v\u1ec1 th\u1ef1c ph\u1ea9m v\u00e0 thu\u1ed1c. Tuy nhi\u00ean, b\u01b0\u1edbc ngo\u1eb7t th\u1ef1c s\u1ef1 x\u1ea3y ra sau khi ban h\u00e0nh \u0110\u1ea1o lu\u1eadt Th\u1ef1c ph\u1ea9m, D\u01b0\u1ee3c ph\u1ea9m v\u00e0 M\u1ef9 ph\u1ea9m Li\u00ean bang n\u0103m 1938, trao cho FDA quy\u1ec1n h\u1ea1n r\u1ed9ng l\u1edbn h\u01a1n, bao g\u1ed3m quy\u1ec1n ph\u00ea duy\u1ec7t c\u00e1c lo\u1ea1i thu\u1ed1c m\u1edbi tr\u01b0\u1edbc khi \u0111\u01b0a ra th\u1ecb tr\u01b0\u1eddng. K\u1ec3 t\u1eeb \u0111\u00f3, v\u1edbi s\u1ef1 ti\u1ebfn b\u1ed9 c\u1ee7a khoa h\u1ecdc v\u00e0 c\u00f4ng ngh\u1ec7 v\u00e0 n\u00e2ng cao nh\u1eadn th\u1ee9c v\u1ec1 s\u1ee9c kh\u1ecfe c\u1ed9ng \u0111\u1ed3ng, ph\u1ea1m vi ch\u1ee9c n\u0103ng c\u1ee7a FDA \u0111\u00e3 li\u00ean t\u1ee5c \u0111\u01b0\u1ee3c m\u1edf r\u1ed9ng \u0111\u1ec3 bao g\u1ed3m c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc, thi\u1ebft b\u1ecb y t\u1ebf, m\u1ef9 ph\u1ea9m v\u00e0 c\u00e1c l\u0129nh v\u1ef1c kh\u00e1c, v\u00e0 h\u1ec7 th\u1ed1ng ch\u1ee9ng nh\u1eadn c\u1ee7a n\u00f3 c\u0169ng \u0111\u00e3 \u0111\u01b0\u1ee3c c\u1ea3i thi\u1ec7n t\u1eebng ng\u00e0y.\n        \u0110i\u1ec1u ki\u1ec7n ch\u1ee9ng nh\u1eadn c\u1ee7a FDA<\/strong>\n        \u0110\u1ec3 c\u00f3 \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn FDA, b\u1ea1n c\u1ea7n \u0111\u00e1p \u1ee9ng c\u00e1c \u0111i\u1ec1u ki\u1ec7n c\u01a1 b\u1ea3n sau: \n        Tu\u00e2n th\u1ee7: S\u1ea3n ph\u1ea9m ph\u1ea3i tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh v\u00e0 quy \u0111\u1ecbnh c\u1ee7a FDA. T\u00f9y thu\u1ed9c v\u00e0o vi\u1ec7c ph\u00e2n lo\u1ea1i v\u00e0 s\u1eed d\u1ee5ng c\u00e1c s\u1ea3n ph\u1ea9m kh\u00e1c nhau, FDA s\u1ebd c\u00f3 c\u00e1c y\u00eau c\u1ea7u quy \u0111\u1ecbnh t\u01b0\u01a1ng \u1ee9ng v\u00e0 c\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n \u0111\u1ea3m b\u1ea3o r\u1eb1ng thi\u1ebft k\u1ebf, s\u1ea3n xu\u1ea5t v\u00e0 d\u00e1n nh\u00e3n s\u1ea3n ph\u1ea9m tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh n\u00e0y. \n        An to\u00e0n: S\u1ea3n ph\u1ea9m ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u00e0 ki\u1ec3m tra \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng n\u00f3 kh\u00f4ng g\u00e2y ra r\u1ee7i ro ho\u1eb7c t\u00e1c h\u1ea1i \u0111\u00e1ng k\u1ec3 cho ng\u01b0\u1eddi d\u00f9ng trong \u0111i\u1ec1u ki\u1ec7n s\u1eed d\u1ee5ng b\u00ecnh th\u01b0\u1eddng. C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n cung c\u1ea5p d\u1eef li\u1ec7u v\u00e0 b\u00e1o c\u00e1o an to\u00e0n c\u00f3 li\u00ean quan \u0111\u1ec3 ch\u1ee9ng minh s\u1ef1 an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m. \n        Hi\u1ec7u qu\u1ea3: \u0110\u1ed1i v\u1edbi thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf, s\u1ea3n ph\u1ea9m ph\u1ea3i c\u00f3 t\u00e1c d\u1ee5ng \u0111i\u1ec1u tr\u1ecb ho\u1eb7c hi\u1ec7u qu\u1ea3 \u0111i\u1ec1u tr\u1ecb nh\u1ea5t \u0111\u1ecbnh. C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n cung c\u1ea5p d\u1eef li\u1ec7u khoa h\u1ecdc v\u00e0 k\u1ebft qu\u1ea3 th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng \u0111\u1ec3 ch\u1ee9ng minh t\u00ednh hi\u1ec7u qu\u1ea3 c\u1ee7a s\u1ea3n ph\u1ea9m. \n        Ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng: C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n thi\u1ebft l\u1eadp m\u1ed9t h\u1ec7 th\u1ed1ng \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng nghi\u00eam ng\u1eb7t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o t\u00ednh nh\u1ea5t qu\u00e1n c\u1ee7a s\u1ea3n ph\u1ea9m v\u00e0 \u1ed5n \u0111\u1ecbnh ch\u1ea5t l\u01b0\u1ee3ng. \u0110i\u1ec1u n\u00e0y bao g\u1ed3m vi\u1ec7c \u00e1p d\u1ee5ng c\u00e1c th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt s\u1ea3n xu\u1ea5t t\u1ed1t (ch\u1eb3ng h\u1ea1n nh\u01b0 GMP) v\u00e0 c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng, ghi l\u1ea1i c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t v\u00e0 th\u1ef1c hi\u1ec7n ki\u1ec3m tra v\u00e0 th\u1eed nghi\u1ec7m. \n        T\u00e0i li\u1ec7u v\u00e0 t\u00e0i li\u1ec7u \u0111\u0103ng k\u00fd: C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u n\u1ed9p c\u00e1c t\u00e0i li\u1ec7u v\u00e0 t\u00e0i li\u1ec7u \u0111\u0103ng k\u00fd chi ti\u1ebft, bao g\u1ed3m m\u00f4 t\u1ea3 s\u1ea3n ph\u1ea9m, th\u00e0nh ph\u1ea7n, c\u00f4ng th\u1ee9c, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, d\u1eef li\u1ec7u an to\u00e0n, d\u1eef li\u1ec7u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng, th\u00f4ng tin ghi nh\u00e3n v\u00e0 \u0111\u00f3ng g\u00f3i, v.v. \n        Qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng: C\u00e1c nh\u00e0 s\u1ea3n xu\u1ea5t c\u1ea7n m\u1ed9t h\u1ec7 th\u1ed1ng qu\u1ea3n l\u00fd ch\u1ea5t l\u01b0\u1ee3ng hi\u1ec7u qu\u1ea3, bao g\u1ed3m truy xu\u1ea5t ngu\u1ed3n g\u1ed1c s\u1ea3n ph\u1ea9m, truy xu\u1ea5t ngu\u1ed3n g\u1ed1c v\u00e0 b\u00e1o c\u00e1o s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i.\n        \"\"\n        Quy tr\u00ecnh ch\u1ee9ng nh\u1eadn FDA<\/strong>\n        Qu\u00e1 tr\u00ecnh ch\u1ee9ng nh\u1eadn c\u1ee7a FDA c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c chia th\u00e0nh nhi\u1ec1u giai \u0111o\u1ea1n: pre-trial, n\u1ed9p \u0111\u01a1n, xem x\u00e9t, ki\u1ec3m tra on-site (n\u1ebfu c\u1ea7n), ra quy\u1ebft \u0111\u1ecbnh v\u00e0 gi\u00e1m s\u00e1t follow-up. \n        - Giai \u0111o\u1ea1n tr\u01b0\u1edbc khi x\u00e9t x\u1eed: Doanh nghi\u1ec7p c\u1ea7n nghi\u00ean c\u1ee9u k\u1ef9 c\u00e1c quy \u0111\u1ecbnh v\u00e0 v\u0103n b\u1ea3n h\u01b0\u1edbng d\u1eabn li\u00ean quan c\u1ee7a FDA \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng m\u1ecdi y\u00eau c\u1ea7u. \u0110\u1ed3ng th\u1eddi, chu\u1ea9n b\u1ecb t\u00e0i li\u1ec7u khai b\u00e1o chi ti\u1ebft, bao g\u1ed3m nh\u01b0ng kh\u00f4ng gi\u1edbi h\u1ea1n \u1edf m\u00f4 t\u1ea3 s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, ph\u00e2n t\u00edch th\u00e0nh ph\u1ea7n, d\u1eef li\u1ec7u th\u1eed nghi\u1ec7m l\u00e2m s\u00e0ng (\u0111\u1ed1i v\u1edbi thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf), v.v. \n        - N\u1ed9p h\u1ed3 s\u01a1: T\u1ea3i l\u00ean th\u00f4ng tin qua c\u1ed5ng g\u1eedi \u0111i\u1ec7n t\u1eed c\u1ee7a FDA (nh\u01b0 eCTD) v\u00e0 thanh to\u00e1n ph\u00ed \u0111\u0103ng k\u00fd t\u01b0\u01a1ng \u1ee9ng. Sau \u0111\u00f3, FDA s\u1ebd ti\u1ebfn h\u00e0nh xem x\u00e9t s\u01a1 b\u1ed9 \u0111\u01a1n \u0111\u0103ng k\u00fd \u0111\u1ec3 x\u00e1c nh\u1eadn t\u00ednh \u0111\u1ea7y \u0111\u1ee7 v\u00e0 tu\u00e2n th\u1ee7 c\u1ee7a th\u00f4ng tin. \n        - R\u00e0 so\u00e1t v\u00e0 ki\u1ec3m tra t\u1ea1i ch\u1ed7: \u0110\u1ed9i ng\u0169 chuy\u00ean gia c\u1ee7a FDA s\u1ebd ti\u1ebfn h\u00e0nh r\u00e0 so\u00e1t chuy\u00ean s\u00e2u c\u00e1c t\u00e0i li\u1ec7u \u1ee9ng d\u1ee5ng v\u00e0 s\u1eafp x\u1ebfp ki\u1ec3m tra t\u1ea1i ch\u1ed7 n\u1ebfu c\u1ea7n thi\u1ebft \u0111\u1ec3 x\u00e1c minh t\u00ednh nh\u1ea5t qu\u00e1n c\u1ee7a \u0111i\u1ec1u ki\u1ec7n s\u1ea3n xu\u1ea5t th\u1ef1c t\u1ebf c\u1ee7a doanh nghi\u1ec7p v\u00e0 s\u1ed1 li\u1ec7u khai b\u00e1o. \n        - Quy\u1ebft \u0111\u1ecbnh: D\u1ef1a tr\u00ean k\u1ebft qu\u1ea3 r\u00e0 so\u00e1t v\u00e0 ki\u1ec3m tra t\u1ea1i ch\u1ed7 (n\u1ebfu c\u00f3), FDA s\u1ebd \u0111\u01b0a ra quy\u1ebft \u0111\u1ecbnh c\u00f3 ph\u00ea duy\u1ec7t ch\u1ee9ng nh\u1eadn hay kh\u00f4ng. Sau khi \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn, c\u00e1c doanh nghi\u1ec7p c\u00f3 th\u1ec3 s\u1eed d\u1ee5ng logo ch\u1ee9ng nh\u1eadn c\u1ee7a FDA tr\u00ean c\u00e1c s\u1ea3n ph\u1ea9m c\u1ee7a h\u1ecd v\u00e0 \u0111\u01b0\u1ee3c h\u01b0\u1edfng uy t\u00edn cao h\u01a1n tr\u00ean th\u1ecb tr\u01b0\u1eddng to\u00e0n c\u1ea7u. \n        - Gi\u00e1m s\u00e1t theo d\u00f5i: FDA th\u1ef1c hi\u1ec7n gi\u00e1m s\u00e1t li\u00ean t\u1ee5c c\u00e1c doanh nghi\u1ec7p \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn, bao g\u1ed3m ki\u1ec3m tra th\u01b0\u1eddng xuy\u00ean, xem x\u00e9t b\u00e1o c\u00e1o s\u1ef1 c\u1ed1 b\u1ea5t l\u1ee3i,... \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o ch\u1ea5t l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m lu\u00f4n \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n. \n        N\u00f3i m\u1ed9t c\u00e1ch d\u1ec5 hi\u1ec3u, ch\u1ee9ng nh\u1eadn c\u1ee7a FDA l\u00e0 m\u1ed9t c\u1ed9t m\u1ed1c quan tr\u1ecdng trong l\u0129nh v\u1ef1c qu\u1ea3n l\u00fd th\u1ef1c ph\u1ea9m v\u00e0 d\u01b0\u1ee3c ph\u1ea9m. Quy tr\u00ecnh ph\u00e1t tri\u1ec3n, quy tr\u00ecnh ch\u1ee9ng nh\u1eadn, t\u1ea7m quan tr\u1ecdng v\u00e0 t\u00e1c \u0111\u1ed9ng to\u00e0n c\u1ea7u c\u1ee7a n\u00f3 x\u1ee9ng \u0111\u00e1ng v\u1edbi s\u1ef1 hi\u1ec3u bi\u1ebft v\u00e0 ph\u1ea3n \u00e1nh s\u00e2u s\u1eafc c\u1ee7a ch\u00fang t\u00f4i. Trong th\u1eddi \u0111\u1ea1i \u0111\u1ea7y th\u00e1ch th\u1ee9c v\u00e0 c\u01a1 h\u1ed9i n\u00e0y, ch\u00fang t\u00f4i hy v\u1ecdng FDA s\u1ebd ti\u1ebfp t\u1ee5c \u0111\u00f3ng vai tr\u00f2 h\u00e0ng \u0111\u1ea7u trong vi\u1ec7c h\u1ed9 t\u1ed1ng s\u1ef1 nghi\u1ec7p s\u1ee9c kh\u1ecfe con ng\u01b0\u1eddi.\n<\/code><\/pre>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"themepark_post_bcolor":"#f5f5f5","themepark_post_width":"1022px","themepark_post_img":"","themepark_post_img_po":"left","themepark_post_img_re":false,"themepark_post_img_cover":false,"themepark_post_img_fixed":false,"themepark_post_hide_title":false,"themepark_post_main_b":"","themepark_post_main_p":100,"themepark_paddingblock":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2307","post","type-post","status-publish","format-standard","hentry","category-news"],"metadata":{"_edit_lock":["1724921823:1"],"views":["313"]},"medium_url":false,"thumbnail_url":false,"full_url":false,"_links":{"self":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2307","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/comments?post=2307"}],"version-history":[{"count":1,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2307\/revisions"}],"predecessor-version":[{"id":2308,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2307\/revisions\/2308"}],"wp:attachment":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media?parent=2307"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/categories?post=2307"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/tags?post=2307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}