{"id":17003,"date":"2025-05-07T11:39:44","date_gmt":"2025-05-07T03:39:44","guid":{"rendered":"https:\/\/greenoo.tw\/?p=17003"},"modified":"2025-05-07T11:39:44","modified_gmt":"2025-05-07T03:39:44","slug":"fda%e5%90%88%e8%a6%8f%e5%bf%85%e8%ae%80%ef%bc%9a483%e8%a1%a8%e6%a0%bc%e3%80%81eir%e5%92%8c%e8%ad%a6%e5%91%8a%e4%bf%a1%e7%9a%84%e5%ae%8c%e6%95%b4%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda%e5%90%88%e8%a6%8f%e5%bf%85%e8%ae%80%ef%bc%9a483%e8%a1%a8%e6%a0%bc%e3%80%81eir%e5%92%8c%e8%ad%a6%e5%91%8a%e4%bf%a1%e7%9a%84%e5%ae%8c%e6%95%b4%e6%8c%87%e5%8d%97\/","title":{"rendered":"FDA\u5408\u898f\u5fc5\u8b80\uff1a483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\u7684\u5b8c\u6574\u6307\u5357"},"content":{"rendered":"<h1>FDA\u5408\u898f\u5fc5\u8b80\uff1a483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\u7684\u5b8c\u6574\u6307\u5357<\/h1>\n<p>\u5c31\u7528\u4e86\u9019\u4e09\u62db\uff0c\u6211\u6210\u529f\u5354\u52a9\u591a\u5bb6\u53f0\u7063\u4f01\u696d\u901a\u904eFDA\u6aa2\u67e5\uff01\u4f5c\u70ba\u8de8\u5883\u54c1\u724c\u5546\uff0c\u4e86\u89e3FDA\u7684\u6aa2\u67e5\u5831\u544a\u9ad4\u7cfb\u662f\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u57fa\u672c\u529f\u3002\u4eca\u5929\u5c31\u70ba\u5404\u4f4d\u8a73\u7d30\u89e3\u6790FDA\u7684\u4e09\u5927\u95dc\u9375\u6587\u4ef6\uff1a483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\u3002<\/p>\n<h2>\u4e00\u3001FDA 483\u8868\u683c\uff1a\u73fe\u5834\u89c0\u5bdf\u5831\u544a<\/h2>\n<p>FDA 483\u8868\u683c\uff0c\u53c8\u7a31\u300c\u73fe\u5834\u89c0\u5bdf\u5831\u544a\u300d\uff0c\u662fFDA\u6aa2\u67e5\u5b98\u6839\u64dacGMP\u898f\u7bc4\u5c0d\u91ab\u85e5\u4f01\u696d\u8cea\u91cf\u9ad4\u7cfb\u9032\u884c\u6aa2\u67e5\u6642\u767c\u73fe\u7684\u4e0d\u7b26\u5408\u9805\u6e05\u55ae\u3002\u9019\u662fFDA\u5411\u4f01\u696d\u767c\u51fa\u7684\u7b2c\u4e00\u9053\u8b66\u8a0a\u3002<\/p>\n<p>\u6bd4\u5982FDA\u6aa2\u67e5\u5b98\u53ef\u80fd\u6703\u767c\u73fe\uff1a<\/p>\n<ul>\n<li>\u751f\u7522\u6d41\u7a0b\u4e0d\u7b26\u5408\u898f\u7bc4<\/li>\n<li>\u8cea\u91cf\u63a7\u5236\u4e0d\u5b8c\u5584<\/li>\n<li>\u8a18\u9304\u4fdd\u5b58\u4e0d\u9054\u6a19<\/li>\n<\/ul>\n<p>\u66f4\u96e3\u80fd\u53ef\u8cb4\u7684\u662f\uff0cFDA\u7d66\u4f01\u696d\u63d0\u4f9b\u4e86\u6539\u6b63\u6a5f\u6703\u3002\u4f46\u8981\u6ce8\u610f\uff0c\u6574\u6539\u671f\u9650\u50c5\u670915\u5929\uff01\u5982\u679c\u672a\u80fd\u5728\u9650\u671f\u5167\u5b8c\u6210\u6574\u6539\uff0cFDA\u53ef\u80fd\u6703\u63a1\u53d6\u9032\u4e00\u6b65\u884c\u52d5\uff0c\u5305\u62ec\u4e8c\u6b21\u9a57\u5ee0\u3001\u7522\u54c1\u53ec\u56de\uff0c\u751a\u81f3\u5c07\u4f01\u696d\u5217\u5165\u9ed1\u540d\u55ae\u3002<\/p>\n<h2>\u4e8c\u3001\u5de5\u5ee0\u8abf\u67e5\u5831\u544a(EIR)\uff1a\u5168\u9762\u8a55\u4f30<\/h2>\n<p>\u9664\u4e86483\u8868\u683c\uff0cFDA\u6aa2\u67e5\u5b98\u9084\u6703\u88fd\u4f5c\u5de5\u5ee0\u8abf\u67e5\u5831\u544a(EIR)\u3002\u9019\u4efd\u5831\u544a\u901a\u5e38\u572830\u500b\u5de5\u4f5c\u65e5\u5167\u5b8c\u6210\uff0c\u4e26\u7531FDA\u8fa6\u516c\u5ba4\u8ca0\u8cac\u4eba\u5be9\u6838\u3002<\/p>\n<p>EIR\u6703\u88ab\u5206\u70ba\u4e09\u7a2e\u4e0d\u540c\u7684\u72c0\u614b\uff1a<\/p>\n<ol>\n<li>NAI\uff1a\u4e0d\u9700\u63a1\u53d6\u63aa\u65bd \u2013 \u6aa2\u67e5\u671f\u9593\u6c92\u6709\u767c\u73fe\u9055\u898f\u9805\u76ee<\/li>\n<li>VAI\uff1a\u81ea\u9858\u63a1\u53d6\u63aa\u65bd \u2013 \u767c\u73fe\u4e86\u9055\u898f\u9805\u76ee\uff0c\u4f46\u4e0d\u9700\u5b98\u65b9\u63a1\u53d6\u884c\u52d5<\/li>\n<li>OAI\uff1a\u5b98\u65b9\u9700\u63a1\u53d6\u884c\u52d5 \u2013 \u767c\u73fe\u9055\u898f\u9805\u76ee\uff0c\u9700\u63a1\u53d6\u9032\u4e00\u6b65\u6cd5\u898f\u63aa\u65bd<\/li>\n<\/ol>\n<p>\u7562\u7adf\uff0c\u4f01\u696d\u7684\u76ee\u6a19\u61c9\u8a72\u662f\u9054\u5230NAI\u6216\u81f3\u5c11VAI\u7684\u8a55\u7d1a\uff0c\u907f\u514d\u66f4\u56b4\u91cd\u7684\u5f8c\u679c\u3002<\/p>\n<h2>\u4e09\u3001\u8b66\u544a\u4fe1(Warning Letter)\uff1a\u56b4\u91cd\u8b66\u544a<\/h2>\n<p>\u5982\u679c\u5728\u6aa2\u67e5\u904e\u7a0b\u4e2d\u767c\u73fe\u56b4\u91cd\u7f3a\u9677\uff0c\u4e14\u4f01\u696d\u5c0d483\u8868\u683c\u7684\u56de\u8986\u88ab\u8a8d\u70ba\u4e0d\u5145\u5206\uff0cFDA\u5c07\u7c3d\u767c\u8b66\u544a\u4fe1\u3002\u9019\u662f\u4e00\u500b\u975e\u5e38\u56b4\u8085\u7684\u6587\u4ef6\uff0c\u8868\u660eFDA\u5c0d\u4f01\u696d\u7684\u5408\u898f\u72c0\u6cc1\u6df1\u8868\u95dc\u5207\u3002<\/p>\n<p>\u4f01\u696d\u9700\u572815\u500b\u5de5\u4f5c\u65e5\u5167\u56de\u61c9\u8b66\u544a\u4fe1\uff0c\u8a73\u8ff0\u89e3\u6c7a\u65b9\u6848\u53ca\u9810\u9632\u63aa\u65bd\u3002\u6700\u8b93\u4eba\u8dcc\u7834\u773c\u93e1\u7684\u662f\uff0c\u9019\u4e9b\u8b66\u544a\u4fe1\u901a\u5e38\u6703\u5728FDA\u5b98\u65b9\u7db2\u7ad9\u4e0a\u516c\u958b\uff0c\u5c0d\u4f01\u696d\u8072\u8b7d\u9020\u6210\u56b4\u91cd\u5f71\u97ff\uff01<\/p>\n<p>\u5c0d\u65bc\u8a08\u5283\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u8de8\u5883\u51fa\u53e3\u5546\uff0c\u4e86\u89e3\u9019\u4e9bFDA\u6aa2\u67e5\u6587\u4ef6\u7684\u5340\u5225\u548c\u61c9\u5c0d\u7b56\u7565\u81f3\u95dc\u91cd\u8981\u3002\u63d0\u524d\u505a\u597d\u6e96\u5099\uff0c\u56b4\u683c\u9075\u5b88FDA\u898f\u7bc4\uff0c\u624d\u80fd\u78ba\u4fdd\u7522\u54c1\u9806\u5229\u9032\u5165\u7f8e\u570b\u5e02\u5834\uff01<\/p>\n<p>\u6210\u70ba\u7da0\u5708\u5708LINE\u597d\u53cb\uff0c\u4eab\u53d7VIP\u5c08\u5c6c\u670d\u52d9\u8207\u512a\u60e0\uff1a<a href=\"https:\/\/line.me\/ti\/p\/g2Vc38nLnR\" target=\"_blank\" rel=\"noopener\">https:\/\/line.me\/ti\/p\/g2Vc38nLnR<\/a><\/p>\n<p>#FDA\u6aa2\u67e5\u5831\u544a #\u8de8\u5883\u96fb\u5546 #\u53f0\u7063\u88fd\u9020\u5546 #\u8de8\u5883\u54c1\u724c\u5546 #483\u8868\u683c #EIR\u5831\u544a #\u8b66\u544a\u4fe1 #\u5408\u898f\u7d93\u71df #\u570b\u969b\u54c1\u724c #\u4e9e\u99ac\u905c\u5168\u7403\u958b\u5e97<\/p>","protected":false},"excerpt":{"rendered":"<p>FDA\u5408\u898f\u5fc5\u8b80\uff1a483\u8868\u683c\u3001EIR\u548c\u8b66\u544a\u4fe1\u7684\u5b8c\u6574\u6307\u5357 \u5c31\u7528\u4e86\u9019\u4e09\u62db\uff0c\u6211\u6210\u529f\u5354\u52a9\u591a\u5bb6\u53f0\u7063\u4f01\u696d\u901a\u904eFDA\u6aa2\u67e5\uff01\u4f5c\u70ba [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[45],"tags":[],"class_list":["post-17003","post","type-post","status-publish","format-standard","hentry","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17003"}],"collection":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/comments?post=17003"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17003\/revisions"}],"predecessor-version":[{"id":17004,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/17003\/revisions\/17004"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=17003"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=17003"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=17003"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}