{"id":3283,"date":"2024-05-01T07:04:41","date_gmt":"2024-05-01T07:04:41","guid":{"rendered":"https:\/\/greenoo.tw\/?p=3283"},"modified":"2024-05-31T21:12:27","modified_gmt":"2024-05-31T13:12:27","slug":"%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91-%e9%80%b2%e8%bb%8d%e7%be%8e%e5%9c%8b%ef%bc%81%e6%8e%8c%e6%8f%a1fda%e8%aa%8d%e8%ad%89%e7%9a%84%e9%87%8d%e8%a6%81%e6%80%a7","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/%e3%80%90%e7%b6%a0%e5%9c%88%e5%9c%88%e8%aa%aa%e8%b7%a8%e5%a2%83%e3%80%91-%e9%80%b2%e8%bb%8d%e7%be%8e%e5%9c%8b%ef%bc%81%e6%8e%8c%e6%8f%a1fda%e8%aa%8d%e8%ad%89%e7%9a%84%e9%87%8d%e8%a6%81%e6%80%a7\/","title":{"rendered":"\u3010\u7da0\u5708\u5708\u8aaa\u8de8\u5883\u3011-\u9032\u8ecd\u7f8e\u570b\uff01\u638c\u63e1FDA\u8a8d\u8b49\u7684\u91cd\u8981\u6027\u548c\u95dc\u9375\u5206\u985e\ud83d\udca1"},"content":{"rendered":"<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"384\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/US.jpeg\" alt=\"\" class=\"wp-image-3284\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/US.jpeg 600w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/US-300x192.jpeg 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/><\/figure>\n\n\n\n<p>\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4f5c\u70ba\u4e00\u5bb6\u79d1\u5b78\u7ba1\u7406\u6a5f\u69cb\uff0c\u80a9\u8ca0\u8457\u78ba\u4fdd\u7f8e\u570b\u570b\u5167\u751f\u7522\u6216\u9032\u53e3\u7684\u98df\u54c1\u3001\u5316\u599d\u54c1\u3001\u85e5\u54c1\u3001\u91ab\u7642\u5668\u68b0\u548c\u8f3b\u5c04\u96fb\u5b50\u7522\u54c1\u5b89\u5168\u7684\u91cd\u8cac\u3002\ud83d\udee1\ufe0f\u4f5c\u70ba\u6700\u65e9\u4ee5\u4fdd\u8b77\u6d88\u8cbb\u8005\u70ba\u4e3b\u8981\u8077\u80fd\u7684\u806f\u90a6\u6a5f\u69cb\u4e4b\u4e00\uff0cFDA\u5df2\u88ab\u570b\u969b\u516c\u8a8d\u70ba\u4e16\u754c\u4e0a\u6700\u5177\u6b0a\u5a01\u7684\u98df\u54c1\u8207\u85e5\u7269\u7ba1\u7406\u6a5f\u69cb\u4e4b\u4e00\u3002\ud83c\udf0d<\/p>\n\n\n\n<p>\u90a3\u9ebc\uff0c\u70ba\u4f55\u9700\u8981\u9032\u884cFDA\u8a8d\u8b49\u5462\uff1f\ud83e\udd14\u7f8e\u53f0\u5c0d\u65bc\u4e0a\u8ff0\u7522\u54c1\u7684\u5b9a\u7fa9\u5dee\u7570\uff0c\u5c0e\u81f4\u4e86\u7f8e\u570b\u5c0d\u9019\u4e9b\u7522\u54c1\u7684\u5206\u985e\u3001\u7ba1\u8f44\u7bc4\u570d\u8207\u76e3\u7ba1\u8981\u6c42\u5404\u4e0d\u76f8\u540c\uff0c\u56e0\u6b64\u4f01\u696d\u5728\u51fa\u53e3\u81f3\u7f8e\u570b\u524d\u9808\u9032\u884c\u76f8\u61c9\u7684\u8a3b\u518a\u6216\u5099\u6848\uff0c\u4ee5\u907f\u514d\u56e0\u4e0d\u77ad\u89e3\u898f\u5b9a\u800c\u5c0e\u81f4\u88abFDA\u62d2\u7d55\u5165\u5883\u6216\u52a0\u5165\u9ed1\u540d\u55ae\u7684\u98a8\u96aa\u3002\ud83d\uded1<\/p>\n\n\n\n<p>\u4e9e\u99ac\u905c\u92b7\u552e\u7684\u7522\u54c1\u9700\u8981\u9032\u884cFDA\u8a8d\u8b49\u5206\u70ba\u4ee5\u4e0b\u5e7e\u985e\uff1a<br>1)\u98df\u54c1\uff1a\u5305\u62ec\u98df\u7528\u985e\u4ee5\u53ca\u8207\u98df\u7269\u63a5\u89f8\u7684\u7522\u54c1\uff0c\u5b83\u5011\u9700\u8981\u5206\u5225\u9032\u884cFDA\u8a3b\u518a\u53ca\u98df\u54c1\u63a5\u89f8\u6750\u6599\u6aa2\u6e2c\u3002\ud83c\udf4f<\/p>\n\n\n\n<p>2)\u91ab\u7642\u5668\u68b0\uff1a\u6839\u64da\u98a8\u96aa\u7b49\u7d1a\u5206\u70ba\u4e00\u5230\u4e09\u985e\uff0c\u7531\u773c\u93e1\u9019\u985e\u4f4e\u98a8\u96aa\u7522\u54c1\uff0c\u5230\u9700\u8981\u4e0a\u5e02\u524d\u6279\u6e96\u7684\u9ad8\u98a8\u96aa\u7522\u54c1\uff0c\u5982\u624b\u8853\u7528\u6fc0\u5149\u5668\u3002\ud83e\ude7a<\/p>\n\n\n\n<p>3)\u85e5\u54c1\uff1a\u5305\u62ec\u4eba\u985e\u7528\u85e5\u8207\u7378\u7528\u85e5\uff0c\u7279\u5225\u662fOTC\u975e\u8655\u65b9\u85e5\u53caAPI\u539f\u6599\u85e5\u7684\u985e\u5225\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u4e00\u4e9b\u65e5\u5316\u7522\u54c1\u7531\u65bc\u5177\u6709\u7279\u5b9a\u529f\u80fd\u4ea6\u88ab\u6b78\u985e\u65bc\u85e5\u54c1\u7bc4\u7587\u5167\u3002\ud83d\udc8a<\/p>\n\n\n\n<p>4)\u6fc0\u5149\u8f3b\u5c04\u985e\u96fb\u5b50\u7522\u54c1\uff1a\u51fa\u53e3\u81f3\u7f8e\u570b\u524d\u5fc5\u9808\u7372\u5f97Accession Number\u4e26\u901a\u5e38\u8981\u9032\u884cIEC60825\u6aa2\u6e2c\u4ee5\u8b49\u660e\u5176\u6fc0\u5149\u8f3b\u5c04\u5b89\u5168\u3002\ud83d\udd2c<\/p>\n\n\n\n<p>5)\u5316\u599d\u54c1\uff1a\u6839\u64da\u6700\u65b0\u7684MoCRA\u6cd5\u6848\uff0c\u5316\u599d\u54c1\u51fa\u53e3\u81f3\u7f8e\u570b\u5fc5\u9808\u8a3b\u518aFDA\uff0c\u4e14\u53d6\u4ee3\u4e86\u904e\u53bb\u7684\u81ea\u9858\u5316\u599d\u54c1\u8a3b\u518a\u8a08\u5283(VCRP)\u3002\ud83d\udc85<\/p>\n\n\n\n<p>\u7d9c\u4e0a\u6240\u8ff0\uff0c\u5c0d\u65bc\u5e0c\u671b\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u4f01\u696d\u800c\u8a00\uff0c\u9075\u5faaFDA\u7684\u898f\u5b9a\u4e26\u9032\u884c\u5fc5\u8981\u7684\u8a3b\u518a\u548c\u6aa2\u6e2c\u662f\u95dc\u9375\u4e00\u6b65\u3002\ud83d\udd11\u9019\u4e0d\u50c5\u662f\u5c55\u793a\u4f01\u696d\u8cac\u4efb\u611f\u7684\u9ad4\u73fe\uff0c\u66f4\u662f\u78ba\u4fdd\u7522\u54c1\u80fd\u5920\u9806\u5229\u9032\u5165\u7f8e\u570b\u5e02\u5834\u3001\u907f\u514d\u6cd5\u5f8b\u98a8\u96aa\u7684\u91cd\u8981\u7b56\u7565\u3002\u4f01\u696d\u61c9\u6839\u64da\u7522\u54c1\u985e\u5225\u53caFDA\u7684\u8981\u6c42\uff0c\u9032\u884c\u53ca\u6642\u7684\u64cd\u4f5c\uff0c\u4ee5\u7dad\u8b77\u5176\u7522\u54c1\u7684\u5408\u898f\u6027\u548c\u5e02\u5834\u7af6\u722d\u529b\u3002\ud83d\udcc8<\/p>\n\n\n\n<p>\uff02\u5168\u7403\u96fb\u5546\u5275\u696d\uff0c\u9996\u9078\u7da0\u5708\u5708\uff02\uff0c\u7da0\u5708\u5708\u9996\u9078FDA\u64d4\u4fdd\u65b9\u6848\uff0c\u4e0d\u4e0b\u8b49\u9000\u5168\u6b3e\uff0c\u9650\u984d100\u540d\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4f5c\u70ba\u4e00\u5bb6\u79d1\u5b78\u7ba1\u7406\u6a5f\u69cb\uff0c\u80a9\u8ca0\u8457\u78ba\u4fdd\u7f8e\u570b\u570b\u5167\u751f\u7522\u6216\u9032\u53e3\u7684\u98df\u54c1\u3001\u5316\u599d\u54c1\u3001\u85e5\u54c1\u3001\u91ab\u7642\u5668 [&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":"","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":[1,46,45],"tags":[],"class_list":["post-3283","post","type-post","status-publish","format-standard","hentry","category-uncategorized","category-46","category-fda"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/3283"}],"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=3283"}],"version-history":[{"count":1,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/3283\/revisions"}],"predecessor-version":[{"id":3285,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/posts\/3283\/revisions\/3285"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/media?parent=3283"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/categories?post=3283"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/zh\/wp-json\/wp\/v2\/tags?post=3283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}