{"id":9589,"date":"2026-03-03T22:23:32","date_gmt":"2026-03-03T14:23:32","guid":{"rendered":"https:\/\/regask.com\/?p=9589"},"modified":"2026-03-03T22:23:32","modified_gmt":"2026-03-03T14:23:32","slug":"fda%e5%8f%91%e5%b8%83%e4%ba%a7%e5%93%81%e7%89%b9%e5%ae%9a%e6%8c%87%e5%af%bc%e8%8d%89%e6%a1%88%ef%bc%8c%e4%bb%a5%e6%94%af%e6%8c%81%e4%bb%bf%e5%88%b6%e8%8d%af%e5%bc%80%e5%8f%91%e5%92%8canda%e5%ae%a1","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-issues-draft-product-specific-guidances-to-support-generic-drug-development-and-anda-approvals\/","title":{"rendered":"FDA\u53d1\u5e03\u4ea7\u54c1\u7279\u5b9a\u6307\u5357\u8349\u6848\u4ee5\u63d0\u4f9b\u652f\u6301\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u670826\u65e5, <\/strong>\u8fd9<strong> \u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u53d1\u5e03\u4e86\u4e00\u6279\u4ea7\u54c1\u7279\u5b9a\u6307\u5357\uff08PSG\uff09\u8349\u6848\u3002<\/strong> 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class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1808149767 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>FDA\u53d1\u5e03\u4e86\u65b0\u7684\u548c\u4fee\u8ba2\u540e\u7684PSG\u8349\u6848\uff0c\u5176\u4e2d\u6982\u8ff0\u4e86\u76d1\u7ba1\u673a\u6784\u5bf9\u8bc1\u660e\u4ee5\u4e0b\u65b9\u9762\u7684\u671f\u671b\uff1a <strong>\u6cbb\u7597\u7b49\u6548\u6027<\/strong> \u53c2\u8003\u5df2\u5217\u5165\u6e05\u5355\u7684\u836f\u54c1\u3002\u8be5\u6307\u5357\u6db5\u76d698\u79cd\u4ea7\u54c1\uff0c\u5305\u62ec\u4ee5\u4e0b\u4ea7\u54c1\uff1a <strong>\u76ee\u524d\u5c1a\u65e0\u83b7\u6279\u7684\u4eff\u5236\u836f\u3002,<\/strong> \u5e76\u5f15\u5165\u65b0\u7684\u6307\u5bfc\u65b9\u9488 <strong>\u963f\u7247\u7c7b\u836f\u7269\u4f7f\u7528\u969c\u788d\u6cbb\u7597 <\/strong>\u548c<strong> \u53e3\u670d\u7d22\u739b\u9c81\u80bd\u7528\u4e8e\u964d\u4f4e\u5fc3\u8840\u7ba1\u98ce\u9669\u3002.\u00a0<\/strong><\/p>\n<p>\u51e0\u9879\u73b0\u6709\u7684PSG\u8fdb\u884c\u4e86\u4fee\u8ba2\uff0c\u66f4\u65b0\u5185\u5bb9\u5f71\u54cd\u5230 <strong>\u7f13\u91ca\u5236\u5242\u3001\u900f\u76ae\u7ed9\u836f\u7cfb\u7edf\u548c\u5c40\u90e8\u7528\u836f\u7cfb\u7edf\uff0c,<\/strong> \u5bfc\u81f4\u5b66\u4e60\u9884\u671f\u53d1\u751f\u53d8\u5316\uff0c\u4f8b\u5982<strong> \u9152\u7cbe\u5242\u91cf\u503e\u5012\u7814\u7a76 <\/strong>\u548c<strong> \u81f4\u654f\u6027\u6d4b\u8bd5\u3002.<\/strong> \u6b64\u5916\uff0cFDA\u66f4\u65b0\u4e86\u5176\u5728\u7ebf\u6e05\u5355\uff0c\u5c06\u4ee5\u4e0b\u5185\u5bb9\u7eb3\u5165\u5176\u4e2d <strong>\u6b63\u5728\u5f00\u53d1\u4e2d\u7684PSG\u7cfb\u5217\u65b0\u8f66,<\/strong> \u540c\u65f6\u63d0\u4f9b\u9884\u8ba1\u51fa\u7248\u65e5\u671f\uff0c\u4ee5\u652f\u6301\u53d1\u5c55\u89c4\u5212\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-614426694 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-868749282\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-781850203\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-781850203 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9\u4e9b\u8349\u6848PSG\u63d0\u4f9b\u4e86\u66f4\u5927\u7684 <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u5173\u4e8e\u4eff\u5236\u836f\u7814\u53d1\u7684\u7814\u7a76\u8bbe\u8ba1\u548c\u6570\u636e\u8981\u6c42\uff0c\u63d0\u4f9b\u652f\u6301 <strong>\u6570\u5b57\u5316\u5bf9\u9f50\u548c\u89c4\u5212\u6548\u7387<\/strong> \u9488\u5bf9ANDA\u9879\u76ee\u3002\u901a\u8fc7\u660e\u786e\u590d\u6742\u4ea7\u54c1\u548c\u975e\u590d\u6742\u4ea7\u54c1\u7684\u9884\u671f\uff0c\u6b64\u6b21\u66f4\u65b0\u65e8\u5728\u63d0\u9ad8\u53ef\u9884\u6d4b\u6027\uff0c\u540c\u65f6\u4fdd\u6301\u2026\u2026 <strong>\u5f71\u54cd\u4e2d\u6027\uff0c\u4e14\u989d\u5916\u76d1\u7ba1\u8d1f\u62c5\u6781\u5c0f\u3002<\/strong> \u9762\u5411\u884c\u4e1a\u5229\u76ca\u76f8\u5173\u8005\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-868749282 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-22931882\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-340276804\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-340276804 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u9002\u7528\u4e8e <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u7814\u53d1, <\/strong>\u548c<strong> \u6cd5\u5f8b\u56e2\u961f<\/strong> \u53c2\u4e0e\u4eff\u5236\u836f\u5f00\u53d1\u548c ANDA \u7533\u62a5\u7684\u4eba\u5458\uff0c\u7279\u522b\u662f\u90a3\u4e9b\u4ece\u4e8b\u590d\u6742\u914d\u65b9\u6216\u5177\u6709\u4e0d\u65ad\u53d8\u5316\u7684\u7814\u7a76\u8981\u6c42\u7684\u4ea7\u54c1\u7684\u4eba\u5458\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-22931882 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-2098995749\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-334424598\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-334424598 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u516c\u53f8\u5e94\u8be5 <strong>\u8bc4\u4f30\u5f53\u524d\u548c\u8ba1\u5212\u4e2d\u7684ANDA\u7533\u8bf7<\/strong> \u5bf9\u7167\u65b0\u53d1\u5e03\u548c\u4fee\u8ba2\u7684PSG\uff0c\u627e\u51fa\u7814\u7a76\u65b9\u6848\u6216\u6570\u636e\u5305\u4e2d\u7684\u4efb\u4f55\u4e0d\u8db3\u4e4b\u5904\u3002\u5982\u679c\u7814\u53d1\u9879\u76ee\u53ef\u80fd\u53d7\u5230\u5f71\u54cd\uff0c\u7533\u8bf7\u4eba\u53ef\u4ee5\u2026\u2026 <strong>\u8bf7\u6c42\u4e0eFDA\u4e3e\u884c\u7535\u8bdd\u4f1a\u8bae <\/strong>\u5728\u4e0b\u9762<strong> GDUFA III \u627f\u8bfa\u3002.<\/strong> \u5efa\u8bae\u6301\u7eed\u5173\u6ce8 FDA \u7684 PSG \u6e05\u5355\uff0c\u4ee5\u9884\u6d4b\u672a\u6765\u4e0e\u4ea7\u54c1\u7ec4\u5408\u76f8\u5173\u7684\u6307\u5bfc\u610f\u89c1\u3002.<\/p>\n<p>\u968f\u7740\u5bf9\u4eff\u5236\u836f\u7684\u76d1\u7ba1\u671f\u671b\u4e0d\u65ad\u53d8\u5316\uff0c\u63d0\u524d\u4e86\u89e3\u8349\u6848\u548c\u5373\u5c06\u51fa\u53f0\u7684\u836f\u54c1\u5b89\u5168\u6307\u5357\u5bf9\u4e8e\u9ad8\u6548\u7684\u5f00\u53d1\u89c4\u5212\u81f3\u5173\u91cd\u8981\u3002. <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0\uff0c\u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff08\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\uff09\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002. <strong>\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c,<\/strong> <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u89c1\u89e3\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u56e2\u961f\u8ddf\u8e2a FDA \u6307\u5357\u66f4\u65b0\uff0c\u8bc4\u4f30\u5bf9 ANDA \u9879\u76ee\u7684\u5f71\u54cd\uff0c\u5e76\u7b80\u5316 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5408\u89c4\u5de5\u4f5c\u6d41\u7a0b\u3002. <a href=\"http:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a <\/strong><\/a>\u6216\u8005<a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong> \u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-2098995749 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1126380236\">\n\n\t<div id=\"col-894028824\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-408160709\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-408160709 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW45210204 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW45210204 BCX0\">\u4ec0\u4e48\u00a0<\/span><span class=\"NormalTextRun ContextualSpellingAndGrammarErrorV2Themed GrammarErrorHighlight SCXW45210204 BCX0\">\u662f<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0FDA\u4ea7\u54c1\u7279\u5b9a\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW45210204 BCX0\">\u6307\u5bfc<\/span><span class=\"NormalTextRun SCXW45210204 BCX0\">\u00a0\uff08\u5df4\u9ece\u5723\u65e5\u8033\u66fc\u961f\uff09\uff1f<\/span><\/span><span class=\"EOP SCXW45210204 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1849325461\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1849325461 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>FDA PSG \u662f\u6307\u5bfc\u6587\u4ef6\uff0c\u6982\u8ff0\u4e86\u5728\u4eff\u5236\u836f\u7533\u8bf7\u4e2d\u8bc1\u660e\u6cbb\u7597\u7b49\u6548\u6027\u7684\u63a8\u8350\u7814\u7a76\u8bbe\u8ba1\u548c\u6570\u636e\u8981\u6c42\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-894028824 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1453810689\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4><span class=\"TextRun MacChromeBold SCXW266917646 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW266917646 BCX0\">2026 \u5e74 2 \u6708\u7684 PSG \u66f4\u65b0\u8349\u6848\u6db5\u76d6\u4e86\u591a\u5c11\u79cd\u4ea7\u54c1\uff1f<\/span><\/span><span class=\"EOP SCXW266917646 BCX0\" 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