{"id":2302,"date":"2024-08-28T16:14:49","date_gmt":"2024-08-28T08:14:49","guid":{"rendered":"http:\/\/www.csw-vn.cn\/?p=2302"},"modified":"2024-08-28T16:14:49","modified_gmt":"2024-08-28T08:14:49","slug":"%e4%bb%80%e4%b9%88%e6%98%affda%e8%ae%a4%e8%af%81%ef%bc%9ffda%e8%ae%a4%e8%af%81%e6%b5%81%e7%a8%8b%e6%98%af%e6%80%8e%e6%a0%b7%e7%9a%84%ef%bc%9f%e5%b0%86%e4%bc%9a%e9%9d%a2%e4%b8%b4%e5%93%aa%e4%ba%9b","status":"publish","type":"post","link":"http:\/\/www.csw-vn.cn\/vi\/2302.html","title":{"rendered":"Ch\u1ee9ng nh\u1eadn FDA l\u00e0 g\u00ec? Quy tr\u00ecnh ch\u1ee9ng nh\u1eadn c\u1ee7a FDA l\u00e0 g\u00ec? B\u1ea1n s\u1ebd ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nh\u1eefng th\u00e1ch th\u1ee9c n\u00e0o?"},"content":{"rendered":"<pre class=\"wp-block-code\"><code>       <strong> 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      <strong>  Quy tr\u00ecnh ch\u1ee9ng nh\u1eadn FDA<\/strong>\n        Qu\u00e1 tr\u00ecnh ch\u1ee9ng nh\u1eadn FDA r\u1ea5t ph\u1ee9c t\u1ea1p v\u00e0 nghi\u00eam ng\u1eb7t, th\u01b0\u1eddng bao g\u1ed3m c\u00e1c b\u01b0\u1edbc ch\u00ednh sau: \n        1. Ki\u1ec3m tra tr\u01b0\u1edbc v\u00e0 t\u01b0 v\u1ea5n: Tr\u01b0\u1edbc ti\u00ean, c\u00e1c doanh nghi\u1ec7p c\u1ea7n hi\u1ec3u c\u00e1c quy \u0111\u1ecbnh v\u00e0 y\u00eau c\u1ea7u li\u00ean quan c\u1ee7a FDA v\u00e0 chu\u1ea9n b\u1ecb c\u00e1c t\u00e0i li\u1ec7u \u0111\u0103ng k\u00fd chi ti\u1ebft. Trong qu\u00e1 tr\u00ecnh n\u00e0y, vi\u1ec7c t\u00ecm ki\u1ebfm s\u1ef1 gi\u00fap \u0111\u1ee1 c\u1ee7a m\u1ed9t c\u01a1 quan t\u01b0 v\u1ea5n b\u00ean th\u1ee9 ba chuy\u00ean nghi\u1ec7p c\u00f3 th\u1ec3 c\u1ea3i thi\u1ec7n \u0111\u00e1ng k\u1ec3 t\u1ef7 l\u1ec7 th\u00e0nh c\u00f4ng c\u1ee7a \u0111\u01a1n \u0111\u0103ng k\u00fd. \n        Hai. N\u1ed9p \u0111\u01a1n: Doanh nghi\u1ec7p n\u1ed9p c\u00e1c t\u00e0i li\u1ec7u \u1ee9ng d\u1ee5ng \u0111\u00e3 chu\u1ea9n b\u1ecb cho FDA, bao g\u1ed3m c\u00f4ng th\u1ee9c s\u1ea3n ph\u1ea9m, quy tr\u00ecnh s\u1ea3n xu\u1ea5t, h\u1ec7 th\u1ed1ng ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng, d\u1eef li\u1ec7u l\u00e2m s\u00e0ng (\u0111\u1ed1i v\u1edbi thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf), v.v. \n        3. Ki\u1ec3m to\u00e1n v\u00e0 \u0111\u00e1nh gi\u00e1: FDA s\u1ebd ti\u1ebfn h\u00e0nh \u0111\u00e1nh gi\u00e1 chi ti\u1ebft c\u00e1c t\u00e0i li\u1ec7u \u0111\u00e3 n\u1ed9p v\u00e0, n\u1ebfu c\u1ea7n thi\u1ebft, ti\u1ebfn h\u00e0nh ki\u1ec3m tra t\u1ea1i ch\u1ed7 \u0111\u1ec3 x\u00e1c minh n\u0103ng l\u1ef1c s\u1ea3n xu\u1ea5t, m\u1ee9c \u0111\u1ed9 ki\u1ec3m so\u00e1t ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 t\u00ednh x\u00e1c th\u1ef1c v\u00e0 an to\u00e0n c\u1ee7a doanh nghi\u1ec7p. \n        B\u1ed1n. Ph\u1ea3n h\u1ed3i v\u00e0 kh\u1eafc ph\u1ee5c: N\u1ebfu c\u00e1c v\u1ea5n \u0111\u1ec1 \u0111\u01b0\u1ee3c t\u00ecm th\u1ea5y trong qu\u00e1 tr\u00ecnh ki\u1ec3m to\u00e1n, FDA s\u1ebd \u0111\u01b0a ra th\u00f4ng b\u00e1o kh\u1eafc ph\u1ee5c cho doanh nghi\u1ec7p, y\u00eau c\u1ea7u h\u1ecd ho\u00e0n th\u00e0nh c\u00e1c c\u1ea3i ti\u1ebfn t\u01b0\u01a1ng \u1ee9ng trong th\u1eddi gian quy \u0111\u1ecbnh. \n        5. Ph\u00ea duy\u1ec7t v\u00e0 ch\u1ee9ng nh\u1eadn: Sau khi ki\u1ec3m tra v\u00e0 \u0111\u00e1nh gi\u00e1 nghi\u00eam ng\u1eb7t, n\u1ebfu s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u c\u1ee7a FDA, n\u00f3 s\u1ebd \u0111\u01b0\u1ee3c ch\u1ee9ng nh\u1eadn v\u00e0 ph\u00ea duy\u1ec7t b\u1edfi FDA, v\u00e0 gi\u1ea5y ch\u1ee9ng nh\u1eadn ho\u1eb7c s\u1ed1 ph\u00ea duy\u1ec7t t\u01b0\u01a1ng \u1ee9ng s\u1ebd \u0111\u01b0\u1ee3c c\u1ea5p.\n         <img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"222\" class=\"wp-image-1177\" style=\"width: 400px;\" src=\"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/4.jpg\" alt=\"\" srcset=\"http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/4.jpg 450w, http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/4-300x167.jpg 300w, http:\/\/www.csw-vn.cn\/wp-content\/uploads\/2024\/04\/4-18x10.jpg 18w\" sizes=\"auto, (max-width: 400px) 100vw, 400px\" \/>\n      <strong>  Nh\u1eefng th\u00e1ch th\u1ee9c m\u00e0 ch\u1ee9ng nh\u1eadn c\u1ee7a FDA ph\u1ea3i \u0111\u1ed1i m\u1eb7t<\/strong>\n        M\u1eb7c d\u00f9 ch\u1ee9ng nh\u1eadn c\u1ee7a FDA c\u00f3 nhi\u1ec1u l\u1ee3i th\u1ebf, nh\u01b0ng c\u00e1c doanh nghi\u1ec7p c\u0169ng ph\u1ea3i \u0111\u1ed1i m\u1eb7t v\u1edbi nhi\u1ec1u th\u00e1ch th\u1ee9c trong qu\u00e1 tr\u00ecnh \u0111\u0103ng k\u00fd: \n        1. C\u00e1c quy \u0111\u1ecbnh r\u1ea5t ph\u1ee9c t\u1ea1p v\u00e0 c\u00f3 th\u1ec3 thay \u0111\u1ed5i: h\u1ec7 th\u1ed1ng quy \u0111\u1ecbnh c\u1ee7a FDA r\u1ea5t l\u1edbn v\u00e0 \u0111\u01b0\u1ee3c c\u1eadp nh\u1eadt th\u01b0\u1eddng xuy\u00ean. C\u00e1c doanh nghi\u1ec7p ph\u1ea3i lu\u00f4n ch\u00fa \u00fd \u0111\u1ebfn nh\u1eefng ph\u00e1t tri\u1ec3n m\u1edbi nh\u1ea5t \u0111\u1ec3 \u0111\u1ea3m b\u1ea3o r\u1eb1ng c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u m\u1edbi nh\u1ea5t. \n        2. Chu k\u1ef3 ki\u1ec3m to\u00e1n d\u00e0i: Quy tr\u00ecnh ki\u1ec3m to\u00e1n c\u1ee7a FDA r\u1ea5t c\u1ed3ng k\u1ec1nh v\u00e0 t\u1ed1n th\u1eddi gian, v\u00e0 c\u00e1c doanh nghi\u1ec7p c\u1ea7n ph\u1ea3i chu\u1ea9n b\u1ecb \u0111\u1ea7y \u0111\u1ee7 v\u00e0 ki\u00ean nh\u1eabn. \n        3. Ng\u01b0\u1ee1ng k\u1ef9 thu\u1eadt cao: R&amp;D v\u00e0 s\u1ea3n xu\u1ea5t m\u1ed9t s\u1ed1 s\u1ea3n ph\u1ea9m (nh\u01b0 thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf) li\u00ean quan \u0111\u1ebfn c\u00f4ng ngh\u1ec7 cao c\u1ea5p, v\u00e0 c\u00e1c doanh nghi\u1ec7p c\u1ea7n c\u00f3 s\u1ee9c m\u1ea1nh R&amp;D v\u00e0 h\u1ed7 tr\u1ee3 t\u00e0i ch\u00ednh m\u1ea1nh m\u1ebd. \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 gi\u00e1m s\u00e1t th\u1ef1c ph\u1ea9m v\u00e0 thu\u1ed1c. L\u1ecbch s\u1eed 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 \u0111\u00e1ng \u0111\u1ec3 ch\u00fang t\u00f4i hi\u1ec3u v\u00e0 xem x\u00e9t s\u00e2u s\u1eafc. 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 nguy\u00ean nh\u00e2n c\u1ee7a 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-2302","post","type-post","status-publish","format-standard","hentry","category-news"],"metadata":{"_edit_lock":["1724911416:1"],"_edit_last":["1"],"catce":["sidebar-widgets4"],"views":["340"]},"medium_url":false,"thumbnail_url":false,"full_url":false,"_links":{"self":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2302","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=2302"}],"version-history":[{"count":1,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2302\/revisions"}],"predecessor-version":[{"id":2303,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/posts\/2302\/revisions\/2303"}],"wp:attachment":[{"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/media?parent=2302"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/categories?post=2302"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.csw-vn.cn\/vi\/wp-json\/wp\/v2\/tags?post=2302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}