{"id":1207,"date":"2019-08-26T00:00:14","date_gmt":"2019-08-25T16:00:14","guid":{"rendered":"https:\/\/clarivate.com\/tw\/2019\/08\/26\/2009-2018%e5%b9%b4%e5%85%ad%e5%a4%a7%e7%9b%a3%e7%ae%a1%e6%a9%9f%e6%a7%8b%e7%9a%84%e6%96%b0%e8%97%a5%e6%89%b9%e5%87%86%e6%83%85%e6%b3%81\/?lang=zh-hant"},"modified":"2024-10-24T00:27:43","modified_gmt":"2024-10-24T00:27:43","slug":"2018-regulatory-approvals-tackling-unmet-medical-needs","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/zh\/blog\/2018-regulatory-approvals-tackling-unmet-medical-needs\/","title":{"rendered":"2009-2018\u5e74\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u7684\u65b0\u85e5\u6279\u51c6\u60c5\u6cc1"},"content":{"rendered":"<p>\u91ab\u85e5\u6cd5\u898f\u76e3\u7ba1\u74b0\u5883\u7684\u660e\u986f\u6539\u5584\u4ee5\u53ca\u8de8\u570b\u516c\u53f8\u65b0\u85e5\u7533\u5831\u7684\u7b56\u7565\u8b8a\u5316\uff0c\u4f7f\u7372\u5f97\u85e5\u8b49\u6240\u9700\u7684\u6642\u9593\u666e\u904d\u6e1b\u5c11\uff0c\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u4e4b\u9593\u7684\u5354\u8abf\u7d71\u4e00\u6027\u4e5f\u6709\u6240\u63d0\u5347\uff0c\u904e\u53bb10\u5e74 (2009-2018)\u88e1\u7372\u51c6\u4e0a\u5e02\u7684\u65b0\u85e5\u6578\u91cf\u4e5f\u6709\u6240\u6210\u9577\u3002\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u5305\u62ec\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA)\u3001\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40 (FDA)\u3001\u65e5\u672c\u85e5\u54c1\u548c\u91ab\u7642\u5668\u6750\u7ba1\u7406\u5c40 (PMDA)\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\u3001\u745e\u58eb\u91ab\u85e5\u7ba1\u7406\u5c40 (Swissmedic)\u548c\u6fb3\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (TGA)\u3002<\/p>\n<p>\u79d1\u777f\u552f\u5b89\u4e0b\u7684<a href=\"http:\/\/www.cirsci.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3<\/a> (CIRS)\u5728\u984c\u70ba\u300a2009-2018\u5e74\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7684\u65b0\u85e5\uff1a\u95dc\u6ce8\u52a0\u901f\u5be9\u67e5\u901a\u9053\u548c\u5b64\u5152\u85e5\u72c0\u614b\u300b\u7684\u7814\u767c\u5831\u544a\u4e2d\u767c\u4f48\u4e86\u4e00\u9805\u65b0\u7814\u7a76\uff0c\u8a72\u7814\u7a76\u5c0d\u65b0\u6d3b\u6027\u7269\u8cea (New active substance, NAS)\u7684\u7372\u51c6\u60c5\u6cc1\u9032\u884c\u7d71\u8a08\uff0c\u6709\u5982\u4e0b\u767c\u73fe\uff1a<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u66f4\u591a\u7684\u7522\u54c1\u5be6\u73fe\u4e86\u570b\u969b\u5316\u7684\u7533\u8acb\u7b56\u7565<\/strong><\/h3>\n<p>CIRS\u7684\u7d71\u8a08\u8868\u660e\uff0c\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7684\u85e5\u54c1\u6578\u5f9e2009-2013\u5e74\u9593\u768416\u500bNAS\u6210\u9577\u81f32014-2018\u5e74\u9593\u768452\u500bNAS\uff0c\u9019\u8868\u660e\u5728\u6b64\u968e\u6bb5\u5167\uff0c\u6709\u66f4\u591a\u7684\u7522\u54c1\u5be6\u73fe\u4e86\u570b\u969b\u5316\u3002<\/p>\n<p>\u5f71\u97ff\u65b0\u85e5\u63d0\u4ea4\u7533\u8acb\u4e26\u7372\u5f97\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7e3d\u6642\u9593\u7684\u6f5b\u5728\u5f71\u97ff\u56e0\u7d20\u5305\u62ec\uff1a\u516c\u53f8\u7b56\u7565\u3001\u5be9\u67e5\u8a08\u5283\u7684\u985e\u578b\u548c\u5be6\u65bd\u3001\u7522\u54c1\u985e\u578b\u53ca\u5176\u6cbb\u7642\u9818\u57df\u3002\u7279\u5225\u662f\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u3001\u5b64\u5152\u85e5\u8cc7\u683c\u548c\u7533\u8acb\u4eba\u898f\u6a21\u662f\u5f71\u97ff\u63d0\u4ea4\u548c\u6838\u51c6\u7684\u4e3b\u8981\u56e0\u7d20\u3002<\/p>\n<div id=\"attachment_5705\" style=\"width: 688px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-5705\" class=\"wp-image-5705 size-full\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-1.png\" alt=\"\u57161\uff1a\u76e3\u7ba1\u74b0\u5883\u7684\u6539\u5584\u6709\u52a9\u65bc\u7372\u5f97\u4e0a\u5e02\u8a31\u53ef\u6240\u9700\u6642\u9593\u7684\u666e\u904d\u7e2e\u77ed\u3002\uff08\u6838\u51c6\u6642\u9593\u70ba\u63d0\u4ea4\u7533\u8acb\u81f3\u7372\u5f97\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u6240\u9700\u7684\u6642\u9593\u3002\u6642\u9593\u5305\u62ec\u76e3\u7ba1\u6a5f\u69cb\u548c\u7533\u8acb\u4eba\u8017\u8cbb\u7684\u6642\u9593\u3002EMA\u6838\u51c6\u6642\u9593\u5305\u62ecEU\u59d4\u54e1\u6703\u8017\u8cbb\u7684\u6642\u9593\u3002\uff09 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3\" width=\"678\" height=\"405\" \/><p id=\"caption-attachment-5705\" class=\"wp-caption-text\">\u57161\uff1a\u76e3\u7ba1\u74b0\u5883\u7684\u6539\u5584\u6709\u52a9\u65bc\u7372\u5f97\u4e0a\u5e02\u8a31\u53ef\u6240\u9700\u6642\u9593\u7684\u666e\u904d\u7e2e\u77ed\u3002\uff08\u6838\u51c6\u6642\u9593\u70ba\u63d0\u4ea4\u7533\u8acb\u81f3\u7372\u5f97\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u6240\u9700\u7684\u6642\u9593\u3002\u6642\u9593\u5305\u62ec\u76e3\u7ba1\u6a5f\u69cb\u548c\u7533\u8acb\u4eba\u8017\u8cbb\u7684\u6642\u9593\u3002EMA\u6838\u51c6\u6642\u9593\u5305\u62ecEU\u59d4\u54e1\u6703\u8017\u8cbb\u7684\u6642\u9593\u3002\uff09 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3<\/p><\/div>\n<p>&nbsp;<\/p>\n<h3><strong>\u95dc\u6ce8\u52a0\u901f\u5be9\u67e5\u901a\u9053<\/strong><\/h3>\n<p>\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u5747\u5df2\u5be6\u65bd\u4e00\u7a2e\u7279\u5b9a\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053\uff0c\u5373\u65e8\u5728\u52a0\u901f\u6709\u524d\u666f\u65b0\u6d3b\u6027\u7269\u8cea\u5be9\u67e5\u9032\u7a0b\u7684\u52a0\u901f\u5be9\u67e5\u8a08\u5283\uff08\u6307EMA\u7684\u300c\u52a0\u901f\u5be9\u67e5\u300d\u3001Swissmedic \u7684\u300c\u7da0\u8272\u901a\u9053\u300d\u548c\u53e6\u5916\u56db\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u7684\u300c\u512a\u5148\u5be9\u67e5\u300d\uff09\u3002TGA\u81ea2017\u5e74\u958b\u59cb\u5be6\u65bd\u512a\u5148\u5be9\u67e5\u9ad4\u7cfb\uff0c2018\u5e74\u7b2c\u4e00\u6b21\u900f\u904e\u8a72\u9ad4\u7cfb\u6838\u51c6\u65b0\u85e5\u3002\u4e00\u822c\u800c\u8a00\uff0c\u900f\u904e\u52a0\u901f\u5be9\u67e5\u8a08\u5283\u6240\u9700\u7684\u6642\u9593\u77ed\u65bc\u6a19\u6e96\u8a08\u5283\u3002<\/p>\n<p>2018\u5e74\uff0cFDA (73%)\u52a0\u901f\u5be9\u67e5\u6240\u5360\u7684\u6bd4\u4f8b\u6700\u9ad8\uff0c\u5176\u6b21\u70ba\u52a0\u62ff\u5927\u885b\u751f\u90e8 (35%)\u3001PMDA (28%)\u3001Swissmedic (13%)\u3001EMA\u548cTGA (10%)\u3002<\/p>\n<p>\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u4e2d\uff0cFDA\u63d0\u4f9b\uff08\u6216\u53ef\u7528\uff09\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u6700\u591a\uff0c\u5305\u62ec\uff1a\u672a\u6eff\u8db3\u91ab\u5b78\u9700\u6c42\u7684\u9818\u57df\u3001\u52a0\u5feb\u85e5\u54c1\u7684\u5be9\u67e5\u548c\/\u6216\u6838\u51c6\uff0c\u4ee5\u63d0\u9ad8\u85e5\u54c1\u7684\u53ef\u53ca\u6027\u30022018\u5e74\uff0cFDA\u6838\u51c6\u7684NAS\u4e2d\u670975%\u7684\u85e5\u54c1\u81f3\u5c11\u5f9e\u4e00\u7a2e\u53ef\u7528\u7684FRP\u4e2d\uff08\u4e0d\u5305\u62ec\u5b64\u5152\u85e5\uff09\u7372\u76ca\u3002\u5176\u4ed6\u6a5f\u69cb\u4e2d\uff0cFRP\u7684\u61c9\u7528\u6bd4\u4f8b\u5728TGA\u768410%\u81f3\u52a0\u62ff\u5927\u885b\u751f\u90e8\u768441%\u4e4b\u9593\uff08\u898b\u57162\uff09\u3002<\/p>\n<div id=\"attachment_5707\" style=\"width: 676px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-5707\" class=\"wp-image-5707 size-full\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-2.png\" alt=\"\u57162\uff1a\u516d\u570b\u76e3\u7ba1\u6a5f\u69cb\u4e2d\uff0cFDA\u63d0\u4f9b\uff08\u6216\u53ef\u7528\uff09\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u6700\u591a\uff0c\u5305\u62ec\uff1a\u672a\u6eff\u8db3\u91ab\u5b78\u9700\u6c42\u7684\u9818\u57df\uff0c\u52a0\u5feb\u85e5\u54c1\u7684\u5be9\u67e5\u548c\/\u6216\u6838\u51c6\uff0c\u4ee5\u63d0\u9ad8\u85e5\u54c1\u7684\u53ef\u53ca\u6027\u3002 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3\" width=\"666\" height=\"397\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-2.png 666w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-2-300x179.png 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-2-67x40.png 67w\" sizes=\"auto, (max-width: 666px) 100vw, 666px\" \/><p id=\"caption-attachment-5707\" class=\"wp-caption-text\">\u57162\uff1a\u516d\u570b\u76e3\u7ba1\u6a5f\u69cb\u4e2d\uff0cFDA\u63d0\u4f9b\uff08\u6216\u53ef\u7528\uff09\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u6700\u591a\uff0c\u5305\u62ec\uff1a\u672a\u6eff\u8db3\u91ab\u5b78\u9700\u6c42\u7684\u9818\u57df\uff0c\u52a0\u5feb\u85e5\u54c1\u7684\u5be9\u67e5\u548c\/\u6216\u6838\u51c6\uff0c\u4ee5\u63d0\u9ad8\u85e5\u54c1\u7684\u53ef\u53ca\u6027\u3002 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3<\/p><\/div>\n<p>&nbsp;<\/p>\n<h3><strong>\u95dc\u6ce8\u5b64\u5152\u85e5\u72c0\u614b<\/strong><\/h3>\n<p>\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u53d6\u5f97\u5b64\u5152\u85e5\u8cc7\u683c\u7684NAS\u6578\u91cf\u5f9e2009-2013\u5e74\u768425%\u63d0\u9ad8\u81f32014-2018\u5e74\u768438%\u30022018\u5e74\uff0cFDA\u6838\u51c6\u7684\u5b64\u5152\u85e5\u6700\u591a (35)\uff0c\u800cPMDA\u7684\u6700\u5c11 (8)\u3002\u52a0\u62ff\u5927\u885b\u751f\u90e8\u73fe\u5728\u5c1a\u672a\u57f7\u884c\u5b64\u5152\u85e5\u653f\u7b56\uff1b\u4f46\u662f\uff0c\u8a72\u6a5f\u69cb2018\u5e74\u6838\u51c6\u4e8615\u500bFDA\u3001EMA\u6216TGA\u5177\u6709\u5b64\u5152\u85e5\u8cc7\u683c\u7684NAS\u3002<\/p>\n<p>2018\u5e74\uff0cFDA\u7684\u5b64\u5152\u85e5\u4e2d\u4f4d\u6838\u51c6\u6642\u9593\u6700\u77ed\uff08243\u65e5\uff09\uff0c\u5176\u4e2d88%\u7684\u85e5\u54c1\u5747\u900f\u904e\u52a0\u901f\u5be9\u67e5\u7372\u51c6\u3002\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u4e2d\uff0c\u53ea\u6709EMA\u7684\u5b64\u5152\u85e5\u4e2d\u4f4d\u6838\u51c6\u6642\u9593\u8d85\u904e\u975e\u5b64\u5152\u85e5\u30022018\u5e74 Swissmedic \u7684\u9019\u4e9b\u6642\u9593\u6307\u6a19\u63a5\u8fd1\u30022018\u5e74 TGA \u6838\u51c6\u7684\u5b64\u5152\u85e5\u4e2d\uff0c20%\u900f\u904e\u525b\u555f\u52d5\u7684\u512a\u5148\u5be9\u67e5\u8a08\u5283\u7372\u51c6\u3002<\/p>\n<p>2014-2018\u5e74\u7372\u5f97\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u768452\u500bNAS\u85e5\u54c1\u4e2d\uff0c\u53ea\u670910\u500bNAS\u85e5\u54c1\u5728\u6240\u6709\u76e3\u7ba1\u6a5f\u69cb\u4e2d\u88ab\u6307\u5b9a\u70ba\u5b64\u5152\u85e5\uff0c\u8868\u660e\u5404\u76e3\u7ba1\u6a5f\u69cb\u9593\u6307\u5b9a\u5b64\u5152\u85e5\u7684\u6a19\u6e96\u6709\u4e00\u5b9a\u5dee\u7570\u3002\u4e00\u822c\u800c\u8a00\uff0c\u5b64\u5152\u85e5NAS\u7684\u4e2d\u4f4d\u63d0\u4ea4\u6642\u9593\u5dee\u9577\u65bc\u975e\u5b64\u5152\u85e5NAS\u3002<\/p>\n<p>\u4e8b\u5be6\u4e0a\uff0c\u5927\u90e8\u5206\u5b64\u5152\u85e5NAS\u90fd\u662f\u7531\u975e\u9802\u5c16\u4f01\u696d\u8a3b\u518a\u7684\uff0c\u7a81\u986f\u5c0f\u85e5\u5ee0\u5728\u63a8\u52d5\u5275\u65b0\u7684\u91cd\u8981\u6027\u3002<\/p>\n<div id=\"attachment_5708\" style=\"width: 613px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-5708\" class=\"wp-image-5708 size-full\" src=\"http:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-3.png\" alt=\"\u57163\uff1aCIRS\u7684\u7d71\u8a08\u8868\u660e\uff0c\u5927\u90e8\u5206\u5b64\u5152\u85e5NAS\u90fd\u662f\u7531\u975e\u9802\u5c16\u4f01\u696d\u8a3b\u518a\u7684\uff0c\u7a81\u9865\u5c0f\u85e5\u5ee0\u5728\u63a8\u52d5\u5275\u65b0\u7684\u91cd\u8981\u6027\u3002 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3\" width=\"603\" height=\"449\" srcset=\"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-3.png 603w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-3-300x223.png 300w, https:\/\/clarivate.com\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2019\/08\/CIRS-2019regulatory-3-54x40.png 54w\" sizes=\"auto, (max-width: 603px) 100vw, 603px\" \/><p id=\"caption-attachment-5708\" class=\"wp-caption-text\">\u57163\uff1aCIRS\u7684\u7d71\u8a08\u8868\u660e\uff0c\u5927\u90e8\u5206\u5b64\u5152\u85e5NAS\u90fd\u662f\u7531\u975e\u9802\u5c16\u4f01\u696d\u8a3b\u518a\u7684\uff0c\u7a81\u9865\u5c0f\u85e5\u5ee0\u5728\u63a8\u52d5\u5275\u65b0\u7684\u91cd\u8981\u6027\u3002 \u4f86\u6e90\uff1a\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3<\/p><\/div>\n<p>&nbsp;<\/p>\n<p><a class=\"btn btn-primary\" href=\"http:\/\/discover.clarivate.com\/LP=2201\" target=\"_blank\" rel=\"noopener noreferrer\">\u4e0b\u8f09\u5b8c\u6574\u4e2d\u6587\u5831\u544a<\/a><\/p>\n<p>[\u8a3b] <a href=\"http:\/\/www.cirsci.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3<\/a><em>\u662f\u79d1\u777f\u552f\u5b89\u65d7\u4e0b\u7684\u4e00\u5bb6\u4f4d\u65bc\u82f1\u570b\u7684\u7368\u7acb\u904b\u71df\u5206\u652f\u6a5f\u6406<\/em><\/p>\n<p>&nbsp;<\/p>\n<p><a class=\"btn btn-primary-accessible\" href=\"https:\/\/clarivate.com\/zh-hant\/products\/biopharma\/\">\u66f4\u591a\u7684\u751f\u7269\u88fd\u85e5\u60c5\u5831\u8cc7\u8a0a<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u91ab\u85e5\u6cd5\u898f\u76e3\u7ba1\u74b0\u5883\u7684\u660e\u986f\u6539\u5584\u4ee5\u53ca\u8de8\u570b\u516c\u53f8\u65b0\u85e5\u7533\u5831\u7684\u7b56\u7565\u8b8a\u5316\uff0c\u4f7f\u7372\u5f97\u85e5\u8b49\u6240\u9700\u7684\u6642\u9593\u666e\u904d\u6e1b\u5c11\uff0c\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u4e4b\u9593\u7684\u5354\u8abf\u7d71\u4e00\u6027\u4e5f\u6709\u6240\u63d0\u5347\uff0c\u904e\u53bb10\u5e74 (2009-2018)\u88e1\u7372\u51c6\u4e0a\u5e02\u7684\u65b0\u85e5\u6578\u91cf\u4e5f\u6709\u6240\u6210\u9577\u3002\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u5305\u62ec\u6b50\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (EMA)\u3001\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40 (FDA)\u3001\u65e5\u672c\u85e5\u54c1\u548c\u91ab\u7642\u5668\u6750\u7ba1\u7406\u5c40 (PMDA)\u3001\u52a0\u62ff\u5927\u885b\u751f\u90e8\u3001\u745e\u58eb\u91ab\u85e5\u7ba1\u7406\u5c40 (Swissmedic)\u548c\u6fb3\u6d32\u85e5\u54c1\u7ba1\u7406\u5c40 (TGA)\u3002 \u79d1\u777f\u552f\u5b89\u4e0b\u7684\u570b\u969b\u6cd5\u898f\u79d1\u5b78\u5275\u65b0\u7814\u7a76\u4e2d\u5fc3 (CIRS)\u5728\u984c\u70ba\u300a2009-2018\u5e74\u516d\u5927\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7684\u65b0\u85e5\uff1a\u95dc\u6ce8\u52a0\u901f\u5be9\u67e5\u901a\u9053\u548c\u5b64\u5152\u85e5\u72c0\u614b\u300b\u7684\u7814\u767c\u5831\u544a\u4e2d\u767c\u4f48\u4e86\u4e00\u9805\u65b0\u7814\u7a76\uff0c\u8a72\u7814\u7a76\u5c0d\u65b0\u6d3b\u6027\u7269\u8cea (New active substance, NAS)\u7684\u7372\u51c6\u60c5\u6cc1\u9032\u884c\u7d71\u8a08\uff0c\u6709\u5982\u4e0b\u767c\u73fe\uff1a &nbsp; \u66f4\u591a\u7684\u7522\u54c1\u5be6\u73fe\u4e86\u570b\u969b\u5316\u7684\u7533\u8acb\u7b56\u7565 CIRS\u7684\u7d71\u8a08\u8868\u660e\uff0c\u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7684\u85e5\u54c1\u6578\u5f9e2009-2013\u5e74\u9593\u768416\u500bNAS\u6210\u9577\u81f32014-2018\u5e74\u9593\u768452\u500bNAS\uff0c\u9019\u8868\u660e\u5728\u6b64\u968e\u6bb5\u5167\uff0c\u6709\u66f4\u591a\u7684\u7522\u54c1\u5be6\u73fe\u4e86\u570b\u969b\u5316\u3002 \u5f71\u97ff\u65b0\u85e5\u63d0\u4ea4\u7533\u8acb\u4e26\u7372\u5f97\u76e3\u7ba1\u6a5f\u69cb\u6838\u51c6\u7e3d\u6642\u9593\u7684\u6f5b\u5728\u5f71\u97ff\u56e0\u7d20\u5305\u62ec\uff1a\u516c\u53f8\u7b56\u7565\u3001\u5be9\u67e5\u8a08\u5283\u7684\u985e\u578b\u548c\u5be6\u65bd\u3001\u7522\u54c1\u985e\u578b\u53ca\u5176\u6cbb\u7642\u9818\u57df\u3002\u7279\u5225\u662f\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u3001\u5b64\u5152\u85e5\u8cc7\u683c\u548c\u7533\u8acb\u4eba\u898f\u6a21\u662f\u5f71\u97ff\u63d0\u4ea4\u548c\u6838\u51c6\u7684\u4e3b\u8981\u56e0\u7d20\u3002 &nbsp; \u95dc\u6ce8\u52a0\u901f\u5be9\u67e5\u901a\u9053 \u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u5747\u5df2\u5be6\u65bd\u4e00\u7a2e\u7279\u5b9a\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053\uff0c\u5373\u65e8\u5728\u52a0\u901f\u6709\u524d\u666f\u65b0\u6d3b\u6027\u7269\u8cea\u5be9\u67e5\u9032\u7a0b\u7684\u52a0\u901f\u5be9\u67e5\u8a08\u5283\uff08\u6307EMA\u7684\u300c\u52a0\u901f\u5be9\u67e5\u300d\u3001Swissmedic \u7684\u300c\u7da0\u8272\u901a\u9053\u300d\u548c\u53e6\u5916\u56db\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u7684\u300c\u512a\u5148\u5be9\u67e5\u300d\uff09\u3002TGA\u81ea2017\u5e74\u958b\u59cb\u5be6\u65bd\u512a\u5148\u5be9\u67e5\u9ad4\u7cfb\uff0c2018\u5e74\u7b2c\u4e00\u6b21\u900f\u904e\u8a72\u9ad4\u7cfb\u6838\u51c6\u65b0\u85e5\u3002\u4e00\u822c\u800c\u8a00\uff0c\u900f\u904e\u52a0\u901f\u5be9\u67e5\u8a08\u5283\u6240\u9700\u7684\u6642\u9593\u77ed\u65bc\u6a19\u6e96\u8a08\u5283\u3002 2018\u5e74\uff0cFDA (73%)\u52a0\u901f\u5be9\u67e5\u6240\u5360\u7684\u6bd4\u4f8b\u6700\u9ad8\uff0c\u5176\u6b21\u70ba\u52a0\u62ff\u5927\u885b\u751f\u90e8 (35%)\u3001PMDA (28%)\u3001Swissmedic (13%)\u3001EMA\u548cTGA (10%)\u3002 \u516d\u5bb6\u76e3\u7ba1\u6a5f\u69cb\u4e2d\uff0cFDA\u63d0\u4f9b\uff08\u6216\u53ef\u7528\uff09\u7684\u52a0\u901f\u5be9\u67e5\u901a\u9053 (FRP)\u6700\u591a\uff0c\u5305\u62ec\uff1a\u672a\u6eff\u8db3\u91ab\u5b78\u9700\u6c42\u7684\u9818\u57df\u3001\u52a0\u5feb\u85e5\u54c1\u7684\u5be9\u67e5\u548c\/\u6216\u6838\u51c6\uff0c\u4ee5\u63d0\u9ad8\u85e5\u54c1\u7684\u53ef\u53ca\u6027\u30022018\u5e74\uff0cFDA\u6838\u51c6\u7684NAS\u4e2d\u670975%\u7684\u85e5\u54c1\u81f3\u5c11\u5f9e\u4e00\u7a2e\u53ef\u7528\u7684FRP\u4e2d\uff08\u4e0d\u5305\u62ec\u5b64\u5152\u85e5\uff09\u7372\u76ca\u3002\u5176\u4ed6\u6a5f\u69cb\u4e2d\uff0cFRP\u7684\u61c9\u7528\u6bd4\u4f8b\u5728TGA\u768410%\u81f3\u52a0\u62ff\u5927\u885b\u751f\u90e8\u768441%\u4e4b\u9593\uff08\u898b\u57162\uff09\u3002&#8230;<\/p>\n","protected":false},"author":2,"featured_media":4616,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1668],"tags":[],"class_list":["post-1207","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-healthcare"],"acf":[],"lang":"zh","translations":{"zh":1207},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1207","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1207"}],"version-history":[{"count":1,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1207\/revisions"}],"predecessor-version":[{"id":303092,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1207\/revisions\/303092"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/4616"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1207"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1207"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1207"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}