{"id":7420,"date":"2025-02-27T09:00:32","date_gmt":"2025-02-27T01:00:32","guid":{"rendered":"https:\/\/naipnews.naipo.com\/?p=7420"},"modified":"2025-02-24T15:42:43","modified_gmt":"2025-02-24T07:42:43","slug":"fda%e5%b0%8f%e5%88%86%e5%ad%90%e6%96%b0%e8%8d%af%e7%94%b3%e8%af%b7%e4%b8%89%e5%a4%a7%e9%80%94%e5%be%84%e8%a7%a3%e6%9e%90%ef%bc%9a505b1%e3%80%81505b2%e4%b8%8e505j","status":"publish","type":"post","link":"https:\/\/naipnews.naipo.com\/zh-hans\/7420\/","title":{"rendered":"FDA\u5c0f\u5206\u5b50\u65b0\u836f\u7533\u8bf7\u4e09\u5927\u9014\u5f84\u89e3\u6790\uff1a505(b)1\u3001505(b)2\u4e0e505(j)"},"content":{"rendered":"<blockquote><p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4f5c\u4e3a\u5168\u7403\u836f\u54c1\u76d1\u7ba1\u7684\u6743\u5a01\u673a\u6784\uff0c\u5bf9\u4e8e\u836f\u54c1\u7684\u5ba1\u6838\u6d41\u7a0b\u5728\u56fd\u9645\u95f4\u6709\u7740\u6307\u6807\u6027\u7684\u5f71\u54cd\u3002\u6839\u636e\u7f8e\u56fd\u300a\u8054\u90a6\u98df\u54c1\u3001\u836f\u7269\u548c\u5316\u5986\u54c1\u6cd5\u300b\uff08Federal Food, Drug, and Cosmetic Act, FD\uff06C Act\uff09\u7b2c505\u6761\u6b3e\uff0c\u9488\u5bf9\u5c0f\u5206\u5b50\u836f\u7269\uff0cFDA\u63d0\u4f9b\u4e86\u4e09\u79cd\u4e3b\u8981\u7684\u65b0\u836f\uff08New drug\uff09\u7533\u8bf7\u9014\u5f84\uff0c\u5206\u522b\u4e3a505(b)1\u3001505(b)2\u548c505(j)\uff0c\u6bcf\u79cd\u9014\u5f84\u5404\u5177\u7279\u70b9\uff0c\u5e76\u9002\u7528\u4e8e\u4e0d\u540c\u7c7b\u578b\u7684\u836f\u7269\u7533\u8bf7\uff0c505(b)1\u53ca505(b)2\u53c8\u53ef\u79f0\u4e3a\u300c\u65b0\u836f\u7533\u8bf7\u300d\uff08New Drug Application\uff0cNDA\uff09\uff0c505(j)\u5219\u53ef\u79f0\u4e3a\u300c\u7b80\u5316\u65b0\u836f\u7533\u8bf7\u300d\uff08Abbreviated New Drug Application\uff0cANDA\uff09\u3002\u5404\u56fd\u516c\u53f8\u5728\u7f8e\u56fd\u7533\u8bf7\u65b0\u836f\u4e0a\u5e02\u65f6\u9700\u8003\u8651\u9002\u5f53\u7684\u7533\u8bf7\u9014\u5f84\uff0c\u4ee5\u4fbf\u8fbe\u5230\u6700\u5feb\u901f\u4e14\u7ecf\u6d4e\u5730\u901a\u8fc7FDA\u5ba1\u6838\u7a0b\u5e8f\u7684\u76ee\u6807\u3002\u4ee5\u4e0b\u5c06\u89e3\u6790\u8fd9\u4e09\u79cd\u7533\u8bf7\u9014\u5f84\u7684\u80cc\u666f\u3001\u7279\u70b9\u3001\u9002\u7528\u8303\u56f4\u53ca\u5e38\u89c1\u4e13\u5229\u6001\u6837\u3002<\/p><\/blockquote>\n<figure id=\"attachment_4335\" aria-describedby=\"caption-attachment-4335\" style=\"width: 1024px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-4335 size-full\" src=\"http:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/E1-3.jpg\" alt=\"\" width=\"1024\" height=\"768\" srcset=\"https:\/\/naipnews.naipo.com\/wp-content\/uploads\/2025\/01\/E1-3.jpg 1024w, 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xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/7420\/#505b1%EF%BC%9A%E5%BC%80%E5%88%9B%E5%85%A8%E6%96%B0%E8%8D%AF%E7%89%A9%E6%97%B6%E4%BB%A3\" title=\"505(b)1\uff1a\u5f00\u521b\u5168\u65b0\u836f\u7269\u65f6\u4ee3\">505(b)1\uff1a\u5f00\u521b\u5168\u65b0\u836f\u7269\u65f6\u4ee3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/7420\/#505b2%EF%BC%9A%E7%AB%99%E5%9C%A8%E5%B7%A8%E4%BA%BA%E7%9A%84%E8%82%A9%E8%86%80%E4%B8%8A\" title=\"505(b)2\uff1a\u7ad9\u5728\u5de8\u4eba\u7684\u80a9\u8180\u4e0a\">505(b)2\uff1a\u7ad9\u5728\u5de8\u4eba\u7684\u80a9\u8180\u4e0a<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/7420\/#505j%EF%BC%9A%E5%8A%A0%E9%80%9F%E5%AD%A6%E5%90%8D%E8%8D%AF%E4%B8%8A%E5%B8%82\" title=\"505(j)\uff1a\u52a0\u901f\u5b66\u540d\u836f\u4e0a\u5e02\">505(j)\uff1a\u52a0\u901f\u5b66\u540d\u836f\u4e0a\u5e02<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/naipnews.naipo.com\/zh-hans\/7420\/#%E7%BB%93%E8%AF%AD\" title=\"\u7ed3\u8bed\">\u7ed3\u8bed<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"505b1%EF%BC%9A%E5%BC%80%E5%88%9B%E5%85%A8%E6%96%B0%E8%8D%AF%E7%89%A9%E6%97%B6%E4%BB%A3\"><\/span><strong>505(b)1<\/strong><strong>\uff1a\u5f00\u521b\u5168\u65b0\u836f\u7269\u65f6\u4ee3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u7533\u8bf7\u80cc\u666f\u53ca\u6d41\u7a0b<\/strong><\/p>\n<p>505(b)1\u662f\u4e3a\u4e86\u5168\u65b0\u836f\u7269\u6216\u5f00\u521b\u6027\u836f\u7269\u5f00\u53d1\u8bbe\u8ba1\u7684\u7533\u8bf7\u9014\u5f84\u3002\u6b64\u9014\u5f84\u4e13\u4e3a\u9700\u8981\u5b8c\u6574\u4e34\u5e8a\u6570\u636e\u652f\u6301\uff0c\u9002\u7528\u4e8e\u5f00\u53d1\u65b0\u9896\u5316\u5b66\u5b9e\u4f53\uff08New chemical entity\uff0cNCE\uff09\u6216\u521b\u65b0\u7684\u836f\u7269\u5e94\u7528\uff0c\u53ef\u79f0\u4e3a\u539f\u5382\u836f\u6216\u4e13\u5229\u836f\uff08\u82e5\u5177\u6709\u4e13\u5229\u4fdd\u62a4\uff09\u3002\u82e5\u9009\u62e9505(b)1\u9014\u5f84\uff0c\u610f\u5473\u7740\u9700\u8981\u4ece\u96f6\u5f00\u59cb\u8fdb\u884c\u7814\u53d1\uff0c\u5305\u62ec\u524d\u671f\u7684\u5316\u5408\u7269\u7b5b\u9009\u3001\u52a8\u7269\u5b9e\u9a8c\u4ee5\u53ca\u591a\u9636\u6bb5\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6574\u4e2a\u8fc7\u7a0b\u5f80\u5f80\u9700\u8981\u6570\u5e74\u7684\u6295\u5165\u3002\u8fd9\u7c7b\u65b0\u836f\u5f00\u53d1\u7684\u5931\u8d25\u7387\u8f83\u9ad8\uff0c\u5728\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u53ef\u80fd\u89e3\u76f2\u5931\u8d25\uff0c\u4f46\u56de\u62a5\u4e30\u539a\uff0c\u56e0\u6b64\u5438\u5f15\u4e86\u4e0d\u5c11\u7814\u53d1\u5b9e\u529b\u96c4\u539a\u7684\u836f\u5382\u3002<\/p>\n<p><strong>\u7279\u70b9<\/strong><\/p>\n<p>\u539f\u5382\u836f\u6216\u4e13\u5229\u836f\u9ad8\u95e8\u574e\u7684\u8981\u6c42\uff0c\u8fd9\u610f\u5473\u7740505(b)1\u7684\u9014\u5f84\u8981\u6c42\u63d0\u4ea4\u8be6\u7ec6\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u4ee5\u5168\u9762\u8bc1\u660e\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002\u7814\u53d1\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u9700\u6295\u5165\u5927\u91cf\u8d44\u91d1\u548c\u65f6\u95f4\uff0c\u8fdb\u884c\u5e7f\u6cdb\u7684\u5b9e\u9a8c\u548c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5e76\u4e14\u6839\u636e\u9700\u8981\uff0c\u53ef\u80fd\u9700\u8981\u591a\u56fd\u591a\u4e2d\u5fc3\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u9ad8\u98ce\u9669\u901a\u5e38\u4ee3\u8868\u9ad8\u62a5\u916c\uff0c\u85c9\u7531\u6210\u529f\u901a\u8fc7505(b)1\u5ba1\u6838\u7684\u836f\u7269\u901a\u5e38\u4eab\u6709\u8f83\u957f\u7684\u5e02\u573a\u72ec\u5360\u671f\uff0c\u4f7f\u7814\u53d1\u836f\u5382\u80fd\u591f\u5728\u8be5\u836f\u7269\u7684\u72ec\u5360\u671f\u5185\u83b7\u53d6\u8f83\u9ad8\u7684\u5229\u6da6\u3002\u7136\u800c\u7814\u53d1\u8fc7\u7a0b\u8017\u65f6\u4e14\u6602\u8d35\uff0c\u4e14\u836f\u7269\u4e0a\u5e02\u7684\u4e0d\u786e\u5b9a\u6027\u8f83\u9ad8\uff0c\u5931\u8d25\u7387\u4e5f\u8f83\u5927\u3002\u82e5\u65e0\u6cd5\u8bc1\u660e\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u7597\u6548\uff0c\u5219\u65e0\u6cd5\u83b7\u5f97FDA\u7684\u6279\u51c6\u3002<\/p>\n<p><strong>\u9002\u7528\u8303\u56f4<\/strong><\/p>\n<p>505(b)1\u901a\u5e38\u9002\u7528\u4e8e\u5168\u65b0\u5316\u5b66\u7ed3\u6784\uff0c\u5bf9\u4e8e\u4ece\u672a\u4e0a\u5e02\u7684\u5168\u65b0\u5316\u5b66\u7ed3\u6784\u7684\u6d3b\u6027\u836f\u7406\u6210\u5206\uff08Active Pharmaceutical Ingredients\uff0cAPI\uff09\uff0c505(b)1\u662f\u552f\u4e00\u9002\u7528\u7684\u7533\u8bf7\u9014\u5f84\uff0c\u800cAPI\u4e13\u5229\u4e5f\u7ecf\u5e38\u662f\u539f\u5382\u836f\u7684\u6838\u5fc3\u4e13\u5229\uff0c\u901a\u5e38\u5e03\u5c40\u65f6\u95f4\u8f83\u65e9\u4e14\u4fdd\u62a4\u8303\u56f4\u8f83\u5927\u3002\u9488\u5bf9\u5df2\u77e5\u836f\u7269\u7684\u65b0\u7528\u9014\u6216\u65b0\u9002\u5e94\u75c7\uff0c\u4f8b\u5982\u53d1\u73b0\u73b0\u6709\u836f\u7269\u7684\u989d\u5916\u7597\u6548\uff0c\u5e76\u5e0c\u671b\u85c9\u7531\u6539\u53d8\u9002\u5e94\u75c7\u3001\u7ed9\u836f\u9014\u5f84\u6216\u5242\u578b\u6765\u63d0\u5347\u7597\u6548\uff0c\u53ef\u9009\u62e9505(b)2\u9014\u5f84\uff0c\u7136\u800c\u82e5\u662f\u53d8\u66f4\u592a\u5927\uff0cFDA\u53ef\u80fd\u8981\u6c42\u987b\u4ee5505(b)1\u9014\u5f84\u8fdb\u884c\u7533\u8bf7\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"505b2%EF%BC%9A%E7%AB%99%E5%9C%A8%E5%B7%A8%E4%BA%BA%E7%9A%84%E8%82%A9%E8%86%80%E4%B8%8A\"><\/span><strong>505(b)2<\/strong><strong>\uff1a\u7ad9\u5728\u5de8\u4eba\u7684\u80a9\u8180\u4e0a<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u7533\u8bf7\u80cc\u666f\u53ca\u6d41\u7a0b<\/strong><\/p>\n<p>505(b)2\u9014\u5f84\u63d0\u4f9b\u4e86\u4e00\u6761\u5229\u7528\u73b0\u6709\u836f\u7269\u6570\u636e\u7684\u5feb\u6377\u7533\u8bf7\u9014\u5f84\u3002\u8be5\u7533\u8bf7\u9014\u5f84\u5141\u8bb8\u836f\u5382\u5f15\u7528\u5df2\u4e0a\u5e02\u836f\u7269\u7684\u6570\u636e\uff0c\u4f8b\u5982\u539f\u5382\u836f\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u5e76\u5728\u6b64\u57fa\u7840\u4e0a\u7ed3\u5408\u81ea\u8eab\u7684\u7814\u7a76\u7ed3\u679c\uff0c\u6765\u8bc1\u660e\u8be5\u65b0\u836f\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002505(b)2\u9014\u5f84\u7684\u7075\u6d3b\u6027\u8f83\u9ad8\uff0c\u7279\u522b\u9002\u5408\u5bf9\u5df2\u4e0a\u5e02\u836f\u7269\u8fdb\u884c\u6539\u826f\u6216\u5e94\u7528\u5728\u65b0\u9002\u5e94\u75c7\u4e0a\u7684\u60c5\u51b5\u3002<\/p>\n<p><strong>\u7279\u70b9<\/strong><\/p>\n<p>505(b)(2)\u9014\u5f84\u4e3a\u836f\u7269\u7814\u53d1\u63d0\u4f9b\u4e86\u4e00\u6761\u76f8\u5bf9\u4fbf\u6377\u4e14\u5177\u6210\u672c\u6548\u76ca\u7684\u9009\u62e9\u3002\u76f8\u8f83\u4e8e505(b)(1)\uff0c\u5176\u7075\u6d3b\u6027\u66f4\u9ad8\uff0c\u7533\u8bf7\u8005\u53ef\u5584\u7528\u539f\u5382\u836f\u65e2\u6709\u6570\u636e\uff0c\u4ec5\u9700\u8865\u5145\u5fc5\u8981\u7684\u4e34\u5e8a\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u6539\u826f\u836f\u7269\u7684\u6709\u6548\u6027\u4e0e\u5b89\u5168\u6027\uff0c\u5927\u5e45\u7f29\u77ed\u7814\u53d1\u65f6\u7a0b\u5e76\u964d\u4f4e\u6210\u672c\u3002\u5931\u8d25\u98ce\u9669\u8f83\u4f4e\u662f505(b)(2)\u7684\u53e6\u4e00\u9879\u4f18\u52bf\uff0c\u7531\u4e8e\u53ef\u5f15\u7528\u90e8\u5206\u65e2\u6709\u6570\u636e\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u89c4\u6a21\u8f83\u5c0f\uff0c\u6240\u9700\u65f6\u95f4\u4e5f\u76f8\u5bf9\u8f83\u77ed\u3002\u8fd9\u4f7f\u5f97\u7814\u53d1\u98ce\u9669\u964d\u4f4e\uff0c\u5931\u8d25\u7387\u76f8\u5bf9\u8f83\u4f4e\u3002\u7136\u800c\uff0c505(b)(2)\u9014\u5f84\u7684\u7ade\u4e89\u6fc0\u70c8\u7a0b\u5ea6\u4e0d\u5bb9\u5c0f\u89d1\u3002\u7531\u4e8e\u5176\u4e0a\u5e02\u901f\u5ea6\u8f83\u5feb\uff0c\u5438\u5f15\u4e86\u4f17\u591a\u836f\u5382\u4e89\u76f8\u6295\u5165\uff0c\u7279\u522b\u662f\u9488\u5bf9\u5e38\u89c1\u75be\u75c5\u7684\u6539\u826f\u836f\u7269\u3002\u5e02\u573a\u7ade\u4e89\u7684\u52a0\u5267\uff0c\u4f7f\u5f97\u4ea7\u54c1\u4e0a\u5e02\u540e\u4e0d\u6613\u83b7\u5f97\u957f\u671f\u5546\u4e1a\u72ec\u5360\u4f18\u52bf\uff0c\u7533\u8bf7\u8005\u9700\u5177\u5907\u66f4\u5f3a\u7684\u5e02\u573a\u8425\u9500\u80fd\u529b\u548c\u4ea7\u54c1\u5dee\u5f02\u5316\u7b56\u7565\uff0c\u4f8b\u5982\u9488\u5bf9\u65e0\u6cd5\u53e3\u670d\u7684\u75c5\u4eba\uff0c\u53d8\u66f4\u836f\u54c1\u7ed9\u836f\u9014\u5f84\u4e3a\u6ce8\u5c04\u5242\u3002<\/p>\n<p><strong>\u9002\u7528\u8303\u56f4<\/strong><\/p>\n<p>505(b)(2) \u9014\u5f84\u4e3b\u8981\u9002\u7528\u4e8e\u5bf9\u5df2\u83b7\u6838\u51c6\u836f\u7269\u8fdb\u884c\u6539\u826f\u7684\u60c5\u5f62\uff0c\u4f8b\u5982\uff1a\u6539\u53d8\u5242\u578b\u3001\u8c03\u6574\u914d\u65b9\u3001\u5f00\u53d1\u65b0\u9002\u5e94\u75c7\u6216\u6539\u53d8\u7ed9\u836f\u9014\u5f84\u7b49\uff08\u5982\u5c06\u952d\u5242\u6539\u4e3a\u6ce8\u5c04\u5242\uff09\uff0c\u4e5f\u5e38\u76f8\u5e94\u4ea7\u751f\u56f4\u7ed5\u6838\u5fc3\u4e13\u5229\uff08\u4f8b\u5982API\u4e13\u5229\uff09\u7684\u5404\u79cd\u536b\u661f\u4e13\u5229\uff08\u4f8b\u5982\uff1a\u5242\u578b\u4e13\u5229\u3001\u7528\u9014\u4e13\u5229\u3001\u914d\u65b9\u4e13\u5229\u2026\u7b49\uff09\uff0c\u53ef\u900f\u8fc7\u4e13\u5229\u7ec4\u5408\u7684\u7b56\u7565\u5f3a\u5316\u4fdd\u62a4\u529b\u9053\u53ca\u5ef6\u957f\u4ea7\u54c1\u4fdd\u62a4\u5468\u671f\uff08\u8bf7\u53c2\u8003\u5317\u7f8e\u667a\u6743\u62a5\uff1a\u300c<a href=\"https:\/\/naipnews.naipo.com\/5154\">\u4e13\u5229\u5e08\u5218\u5bb6\u8c6a\uff1a\u751f\u533b\u65b0\u521b\u987b\u77e5\u7684\u4e94\u5927\u77e5\u8bc6\u4ea7\u6743\u653b\u7565<\/a>\u300d\uff09\u3002\u7136\u800c\uff0c\u7533\u8bf7\u8005\u4ecd\u9700\u8bc1\u660e\u5176\u6539\u826f\u4ea7\u54c1\u76f8\u8f83\u4e8e\u53c2\u8003\u836f\u7269\uff08reference listed drug\uff09\u8fbe\u5230\u6cd5\u5b9a\u6807\u51c6\uff0c\u624d\u80fd\u987a\u5229\u53d6\u5f97\u836f\u8bc1\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"505j%EF%BC%9A%E5%8A%A0%E9%80%9F%E5%AD%A6%E5%90%8D%E8%8D%AF%E4%B8%8A%E5%B8%82\"><\/span><strong>505(j)<\/strong><strong>\uff1a\u52a0\u901f\u5b66\u540d\u836f\u4e0a\u5e02<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u7533\u8bf7\u80cc\u666f\u53ca\u6d41\u7a0b<\/strong><\/p>\n<p>505(j)\u9014\u5f84\u662f\u4e13\u4e3a\u5b66\u540d\u836f\uff08\u5373\u4eff\u5236\u836f\uff09\u7684\u7533\u8bf7\u8bbe\u8ba1\u3002\u5b66\u540d\u836f\u662f\u6307\u4e0e\u539f\u5382\u836f\u5728\u6d3b\u6027\u6210\u5206\u3001\u5242\u578b\u3001\u7ed9\u836f\u9014\u5f84\u548c\u751f\u7269\u7b49\u6548\u6027\uff08bioequivalence\uff0cBE\uff09\u5b8c\u5168\u76f8\u540c\u6216\u76f8\u4f3c\u7684\u836f\u7269\u3002\u6839\u636eFDA\u89c4\u5b9a\uff0c\u5b66\u540d\u836f\u7684\u7533\u8bf7\u8005\u4ec5\u9700\u8bc1\u660e\u5176\u4ea7\u54c1\u4e0e\u539f\u5382\u836f\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\uff0c\u800c\u65e0\u9700\u518d\u91cd\u590d\u8fdb\u884c\u5b8c\u6574\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u8fd9\u79cd\u7b80\u5316\u7684\u7533\u8bf7\u7a0b\u5e8f\u4f7f\u5f97\u5b66\u540d\u836f\u7684\u5f00\u53d1\u6210\u672c\u548c\u5ba1\u6838\u65f6\u95f4\u5927\u5e45\u7f29\u51cf\u3002<\/p>\n<p><strong>\u7279\u70b9<\/strong><\/p>\n<p>505(j) \u9014\u5f84\u56e0\u5176\u5ba1\u6838\u7a0b\u5e8f\u8f83\u4e3a\u7b80\u4fbf\uff0c\u4e14\u5f00\u53d1\u6210\u672c\u76f8\u5bf9\u8f83\u4f4e\uff0c\u6210\u4e3a\u8bb8\u591a\u836f\u5382\u8fdb\u5165\u5e02\u573a\u7684\u9009\u62e9\u3002\u7531\u4e8e\u5b66\u540d\u836f\u53ea\u9700\u8bc1\u660e\u4e0e\u539f\u5382\u836f\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\uff0c\u5373\u53ef\u7533\u8bf7\u4e0a\u5e02\uff0c\u56e0\u6b64\u5ba1\u6838\u8fc7\u7a0b\u8f83505(b)(1) \u548c 505(b)(2) \u66f4\u4e3a\u5feb\u901f\u3002\u7136\u800c\uff0c\u7531\u4e8e\u5b66\u540d\u836f\u7684\u7533\u8bf7\u95e8\u574e\u8f83\u4f4e\uff0c\u5e02\u573a\u7ade\u4e89\u4e5f\u76f8\u5bf9\u6fc0\u70c8\uff0c\u52a0\u4e0a\u5b66\u540d\u836f\u666e\u904d\u8f83\u4f4e\u7684\u5b9a\u4ef7\u7b56\u7565\uff0c\u4f7f\u5f97\u5b66\u540d\u836f\u5e02\u573a\u7684\u5229\u6da6\u7a7a\u95f4\u76f8\u8f83\u4e8e\u539f\u5382\u836f\u8f83\u4e3a\u6709\u9650\u3002<\/p>\n<p><strong>\u9002\u7528\u8303\u56f4<\/strong><\/p>\n<p>505(j) \u9014\u5f84\u4e3b\u8981\u9002\u7528\u4e8e\u539f\u5382\u836f\u4e13\u5229\u5df2\u8fc7\u671f\u6216\u5373\u5c06\u8fc7\u671f\u7684\u60c5\u51b5\uff0c\u5b66\u540d\u836f\u5382\u53ef\u900f\u8fc7\u6b64\u9014\u5f84\u7533\u8bf7\u751f\u4ea7\u5b66\u540d\u836f\u3002\u9009\u62e9\u9002\u5408\u7684\u7533\u8bf7\u9014\u5f84\u5bf9\u4e8e\u836f\u5382\u800c\u8a00\u81f3\u5173\u91cd\u8981\uff0c\u9700\u7efc\u5408\u8003\u8651\u836f\u7269\u7279\u6027\u3001\u7814\u53d1\u8d44\u6e90\u3001\u5e02\u573a\u7ade\u4e89\u7b49\u591a\u65b9\u9762\u56e0\u7d20\u3002\u836f\u5382\u5728\u6cd5\u89c4\u51b3\u7b56\u65f6\uff0c\u5e94\u6839\u636e\u81ea\u8eab\u8d44\u6e90\u4e0e\u5e02\u573a\u72b6\u51b5\uff0c\u6743\u8861\u7814\u53d1\u65f6\u95f4\u3001\u6210\u672c\u53ca\u5e02\u573a\u56de\u62a5\uff0c\u4ee5\u9009\u62e9\u6700\u9002\u5408\u7684\u7533\u8bf7\u9014\u5f84\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%BB%93%E8%AF%AD\"><\/span><strong>\u7ed3\u8bed<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>505(b)1\u3001505(b)2\u548c505(j)\u662fFDA\u63d0\u4f9b\u7684\u4e09\u79cd\u4e0d\u540c\u7684\u65b0\u836f\u7533\u8bf7\u9014\u5f84\uff0c\u5404\u81ea\u9488\u5bf9\u4e0d\u540c\u7c7b\u578b\u7684\u65b0\u836f\u7533\u8bf7\u9700\u6c42\u3002\u836f\u5382\u53ef\u6839\u636e\u5176\u4ea7\u54c1\u7684\u6280\u672f\u521b\u65b0\u5ea6\u3001\u7814\u53d1\u6210\u672c\u3001\u9884\u671f\u7684\u5e02\u573a\u7ade\u4e89\u72b6\u51b5\uff0c\u6765\u9009\u62e9\u6700\u9002\u5408\u7684\u9014\u5f84\uff0c\u4e5f\u8981\u8003\u8651\u4e13\u5229\u8fde\u7ed3\u5236\u5ea6\uff08patent linkage system\uff09\u5bf9\u53d6\u5f97\u836f\u8bc1\u65f6\u7a0b\u5f71\u54cd\u3002\u85c9\u7531\u5408\u7406\u9009\u62e9\u6cd5\u89c4\u9014\u5f84\u3001\u54a8\u8be2\u4e13\u4e1a\u7684\u4e34\u5e8a\u7814\u7a76\u59d4\u6258\u673a\u6784\uff08Contract Research Organization\uff0cCRO\uff09\u3001\u9002\u5f53\u7684\u4e13\u5229\u7b56\u7565\u53ca\u9002\u5e94\u75c7\u6316\u9664\uff08carve-out indication\uff09\u7b49\u7b49\uff0c\u836f\u5382\u53ef\u4ee5\u5728\u4fdd\u969c\u4ea7\u54c1\u8d28\u91cf\u548c\u5e02\u573a\u7ade\u4e89\u529b\u7684\u540c\u65f6\uff0c\u6709\u6548\u7f29\u77ed\u836f\u7269\u4e0a\u5e02\u65f6\u95f4\uff0c\u52a0\u901f\u5176\u4ea7\u54c1\u7684\u4e0a\u5e02\u5e76\u4e3a\u60a3\u8005\u63d0\u4f9b\u66f4\u5b89\u5168\u3001\u6709\u6548\u7684\u6cbb\u7597\u9009\u62e9\u3002<\/p>\n<p><strong>\u53c2\u8003\u6570\u636e\uff1a<\/strong><\/p>\n<ol>\n<li><a href=\"https:\/\/www.fda.gov\/drugs\/types-applications\/new-drug-application-nda\">https:\/\/www.fda.gov\/drugs\/types-applications\/new-drug-application-nda<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/frequently-asked-questions-patents-and-exclusivity#:~:text=Patent%20information%20is%20required%20to,is%20not%20considered%20timely%20filed\">https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/frequently-asked-questions-patents-and-exclusivity#:~:text=Patent%20information%20is%20required%20to,is%20not%20considered%20timely%20filed<\/a>.<\/li>\n<\/ol>\n<p><strong>\u8d23\u4efb\u7f16\u8f91\uff1a\u5434\u78a7\u5a25<\/strong><\/p>\n<p><strong>\u3010\u672c\u6587\u8bba\u8ff0\u4ec5\u4e3a\u4f5c\u8005\u89c1\u89e3\uff0c\u4e0d\u4ee3\u8868\u5176\u4efb\u804c\u5355\u4f4d\u4e4b\u7acb\u573a\u3002\u3011<\/strong><\/p>\n<p><!-- \u4f5c\u8005\u4ecb\u7d39\u958b\u59cb --><\/p>\n<table border=\"0\" width=\"89%\" cellspacing=\"1\" cellpadding=\"8\">\n<tbody>\n<tr>\n<td bgcolor=\"#EFEFF8\">\n<table style=\"margin-bottom: 0px;\" border=\"0\" width=\"100%\" cellspacing=\"0\" cellpadding=\"3\">\n<tbody>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\" width=\"13%\"><strong>\u4f5c\u8005\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\" width=\"87%\">\u5434\u6bd5\u80dc<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u73b0\u4efb\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\">\u6cd5\u89c4\u5206\u6790\u4eba\u5458<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\" bgcolor=\"#DBDBEE\"><strong>\u7ecf\u5386\uff1a<\/strong><\/td>\n<td class=\"Article_content_15px\" bgcolor=\"#DBDBEE\">\u4e13\u5229\u4e8b\u52a1\u6240\u53ca\u836f\u5382\u6cd5\u89c4\u4e13\u5458<\/td>\n<\/tr>\n<tr>\n<td class=\"Article_content_15px\" valign=\"top\"><strong>\u4e13\u957f\uff1a<\/strong><\/td>\n<td 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