{"id":210601,"date":"2023-05-11T09:26:17","date_gmt":"2023-05-11T09:26:17","guid":{"rendered":"https:\/\/www.clarivate.com.cn\/?p=210601"},"modified":"2026-03-12T08:43:50","modified_gmt":"2026-03-12T08:43:50","slug":"mainland-chinas-regulatory-evolution-brings-greater-access-to-novel-drugs","status":"publish","type":"post","link":"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/blog\/mainland-chinas-regulatory-evolution-brings-greater-access-to-novel-drugs\/","title":{"rendered":"\u4e2d\u56fd\u5927\u9646\u76d1\u7ba1\u7684\u6f14\u53d8\u5e26\u6765\u66f4\u591a\u65b0\u836f\u8fdb\u5165\u5e02\u573a"},"content":{"rendered":"<p><strong>\u8fd1\u5e74\u6765\uff0c\u4e2d\u56fd\u5927\u9646\u7b80\u5316\u4e86\u5904\u65b9\u836f\u4e34\u5e8a\u8bd5\u9a8c\u548c\u5ba1\u6279\u7684\u76d1\u7ba1\u65b9\u6848\uff0c\u4f7f\u5f97\u56fd\u5185\u548c\u56fd\u5916\u751f\u4ea7\u5546\u7684\u8bb8\u591a\u5177\u6709\u8feb\u5207\u9700\u6c42\u7684\u7597\u6cd5\u9010\u6b65\u60e0\u53ca\u60a3\u8005\u3002<\/strong><\/p>\n<p>\u8fc7\u53bb\u4e94\u5e74\uff0c\u4e2d\u56fd\u5927\u9646\u533b\u7597\u4fdd\u5065\u7cfb\u7edf\u9886\u5bfc\u5f00\u8db3\u9a6c\u529b\uff0c\u5728\u7f29\u77ed\u65b0\u836f\u5728\u56fd\u5185\u5e02\u573a\u4e0e\u897f\u65b9\u5e02\u573a\u4e4b\u95f4\u53ef\u53ca\u6027\u7684\u6ede\u540e\u95ee\u9898\u4e2d\u53d6\u5f97\u4e86\u91cd\u5927\u8fdb\u5c55\u3002<\/p>\n<p>\u5728\u56fd\u5185\u52a0\u901f\u6279\u51c6\u7684\u4e00\u4e2a\u4e3b\u8981\u969c\u788d\u662f\u836f\u4f01\u4e3a\u4e86\u8865\u5145\u5168\u7403\u8bd5\u9a8c\u4ea7\u751f\u7684\u4e34\u5e8a\u8bc1\u636e\uff0c\u5fc5\u987b\u9075\u5faa\u56fd\u5185\u4e25\u683c\u7684\u6ce8\u518c\u8981\u6c42\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u3002\u4e3a\u4e86\u89e3\u51b3\u8fd9\u4e00\u75db\u70b9\uff0c\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3 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alt=\"\u751f\u7269\u4fe1\u606f\u5b66\u5206\u6790\u670d\u52a1_\u514d\u75ab\u836f\u7814\u53d1\u4f01\u4e1a_\u5168\u7403\u4e0a\u5e02\u836f\u54c1\u7b5b\u9009\u6570\u636e\u5e93\u7cfb\u7edf_\u533b\u836f\u5927\u6570\u636e\" width=\"549\" height=\"344\" srcset=\"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture2-1-300x188.png 300w, https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture2-1-64x40.png 64w, https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture2-1.png 602w\" sizes=\"auto, (max-width: 549px) 100vw, 549px\" \/><\/p>\n<p>\u56fe 2\uff1a\u5ba1\u67e5\u6d41\u7a0b\u4e2d\u6d89\u53ca\u7684\u5173\u952e\u6b65\u9aa4\u548c\u53ef\u80fd\u7684\u7ed3\u679c<sup>[6]<\/sup><\/p>\n<p>\u6211\u4eec\u7684\u7814\u7a76\u8868\u660e\uff0c\u8bb8\u591a\u60a3\u8005\uff08\u7279\u522b\u662f\u60a3\u6709\u7f55\u89c1\u75be\u75c5\u548c\/\u6216\u73b0\u6709\u6cbb\u7597\u65b9\u6848\u65e0\u6548\u7684\u60a3\u8005\uff09\u5df2\u4ece\u4fee\u8ba2\u540e\u7684\u6761\u6b3e\u4e2d\u83b7\u76ca\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u88681\uff1a\u5217\u4e3e\u90e8\u5206\u9002\u5e94\u75c7\u53ca\u4ea7\u54c1\u6839\u636e\u5883\u5916\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u5728\u4e2d\u56fd\u5927\u9646\u83b7\u5f97\u6279\u51c6\/\u6807\u7b7e\u6269\u5c55\uff08\u6765\u6e90\uff1aCDE.org\u3001\u79d1\u777f\u552f\u5b89\u5206\u6790\uff09<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-210603\" src=\"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture1-1-300x199.png\" alt=\"\u56fd\u5bb6\u836f\u54c1\u6570\u636e\u5e93_\u836f\u54c1\u6570\u636e\u5e93\u67e5\u8be2\u7f51\u7ad9_\u533b\u836f\u6570\u636e\u5e93\u7cfb\u7edf_\u65b0\u836f\u60c5\u62a5\u5e93\" width=\"540\" height=\"358\" srcset=\"https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture1-1-300x199.png 300w, https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture1-1-60x40.png 60w, https:\/\/www.clarivate.com.cn\/life-sciences-healthcare\/wp-content\/uploads\/sites\/4\/2023\/07\/Picture1-1.png 602w\" sizes=\"auto, (max-width: 540px) 100vw, 540px\" \/><\/p>\n<p><strong>\u201c<\/strong><strong>\u53cc\u8d62<\/strong><strong>\u201d<\/strong><strong>\u5c40\u9762<\/strong><\/p>\n<p>\u4e2d\u56fd\u7684\u76d1\u7ba1\u5b98\u5458\u4e0d\u4ec5\u5728\u6301\u7eed\u52aa\u529b\u5efa\u7acb\u7a33\u5065\u7684\u5ba1\u6279\u7a0b\u5e8f\uff0c\u786e\u4fdd\u521b\u65b0\u7597\u6cd5\u66f4\u5feb\u5730\u8fdb\u5165\u4e2d\u56fd\u5927\u9646\uff0c\u540c\u65f6\uff0c\u4ed6\u4eec\u8fd8\u5728\u4e89\u53d6\u6539\u5584\u60a3\u8005\u5bf9\u521b\u65b0\u7597\u6cd5\u7684\u53ef\u53ca\u6027\u548c\u8d1f\u62c5\u80fd\u529b\uff0c\u5305\u62ec\u5c06\u6b64\u7c7b\u7597\u6cd5\u7eb3\u5165\u56fd\u5bb6\u533b\u4fdd\u836f\u54c1\u76ee\u5f55 (NRDL) \uff0c\u4ee5\u53ca\u901a\u8fc7\u60e0\u6c11\u4fdd\uff08\u8865\u5145\u5546\u4e1a\u4fdd\u9669\uff09\u7b49\u5176\u4ed6\u521b\u65b0\u6e20\u9053\u83b7\u5f97\u6b64\u7c7b\u7597\u6cd5\u3002\u6b64\u5916\uff0cNMPA \u8fd8\u5efa\u7acb\u4e86\u6d77\u5357\u535a\u9ccc\u4e50\u57ce\u56fd\u9645\u533b\u7597\u65c5\u6e38\u5148\u884c\u533a\uff0c\u4ee5\u5728\u8bd5\u70b9\u5730\u533a\u52a0\u901f\u5ba1\u6279\u6025\u9700\u7684\u3001\u57fa\u4e8e\u771f\u5b9e\u4e16\u754c\u4e34\u5e8a\u8bc1\u636e\u7684\u8fdb\u53e3\u836f\u54c1\u3002<\/p>\n<p><strong>\u7efc\u4e0a\u6240\u8ff0\uff0c\u6700\u8fd1\u7684\u6539\u9769\u548c\u89c4\u5b9a\u5305\u62ec\uff1a<\/strong><\/p>\n<ul>\n<li>\u52a0\u901f\u4e2d\u56fd\u5927\u9646\u66f4\u5feb\u5730\u83b7\u5f97\u8bb8\u591a\u521b\u65b0\u548c\u6539\u8fdb\u7684\u7597\u6cd5<\/li>\n<li>\u589e\u52a0\u53ef\u9009\u6cbb\u7597\u65b9\u6848\u7684\u6570\u91cf\uff0c\u7279\u522b\u8003\u8651\u5230\u5bf9\u73b0\u6709\u6cbb\u7597\u9009\u62e9\u8010\u836f\u548c\/\u6216\u7f3a\u4e4f\u6709\u6548\u6cbb\u7597\u9009\u62e9\u800c\u65e0\u6cd5\u6ee1\u8db3\u533b\u7597\u9700\u6c42\u7684\u7279\u5b9a\u60a3\u8005\u7fa4\u4f53<\/li>\n<li>\u5141\u8bb8\u8de8\u56fd\u516c\u53f8 (MNC) \u901a\u8fc7\u591a\u79cd\u8def\u5f84\u8fdb\u5165\u5229\u6da6\u4e30\u539a\u7684\u5e02\u573a\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>\u53c2\u8003\u6587\u732e<\/p>\n<p><small>[1]Opinion on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, October 2017.<\/small><\/p>\n<p><small>[2]Opinion on the list of new drugs marketed overseas urgently needed in China, August 2018.<\/small><\/p>\n<p><small>[3]First list of overseas new drugs urgently needed in clinical practice, November 2018.<\/small><\/p>\n<p><small>[4]Second list of overseas new drugs urgently needed in clinical practice, May 2019.<\/small><\/p>\n<p><small>[5]Third list of overseas new drugs urgently needed in clinical practice, November 2020.<\/small><\/p>\n<p><small>[6]Clinical technical requirements for overseas drugs not yet imported to China, October 2020.<\/small><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8fd1\u5e74\u6765\uff0c\u4e2d\u56fd\u5927\u9646\u7b80\u5316\u4e86\u5904\u65b9\u836f\u4e34\u5e8a\u8bd5\u9a8c\u548c\u5ba1\u6279\u7684\u76d1\u7ba1\u65b9\u6848\uff0c\u4f7f\u5f97\u56fd\u5185\u548c\u56fd\u5916\u751f\u4ea7\u5546\u7684\u8bb8\u591a\u5177\u6709\u8feb\u5207\u9700\u6c42\u7684\u7597\u6cd5\u9010\u6b65\u60e0\u53ca\u60a3\u8005\u3002 \u8fc7\u53bb\u4e94\u5e74\uff0c\u4e2d\u56fd\u5927\u9646\u533b\u7597\u4fdd\u5065\u7cfb\u7edf\u9886\u5bfc\u5f00\u8db3\u9a6c\u529b\uff0c\u5728\u7f29\u77ed\u65b0\u836f\u5728\u56fd\u5185\u5e02\u573a\u4e0e\u897f\u65b9\u5e02\u573a\u4e4b\u95f4\u53ef\u53ca\u6027\u7684\u6ede\u540e\u95ee\u9898\u4e2d\u53d6\u5f97\u4e86\u91cd\u5927\u8fdb\u5c55\u3002 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