{"id":9630,"date":"2026-03-11T15:38:40","date_gmt":"2026-03-11T07:38:40","guid":{"rendered":"https:\/\/regask.com\/?p=9630"},"modified":"2026-03-11T15:38:40","modified_gmt":"2026-03-11T07:38:40","slug":"fda%e5%b0%b1%e6%9b%b4%e6%96%b0supac%e5%85%b3%e4%ba%8e%e4%b8%8a%e5%b8%82%e5%90%8e%e8%8d%af%e5%93%81%e7%94%9f%e4%ba%a7%e5%8f%98%e6%9b%b4%e7%9a%84%e6%8c%87%e5%af%bc%e5%8e%9f%e5%88%99%e5%90%af%e5%8a%a8","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-opens-public-consultation-on-updating-supac-guidance-for-postapproval-pharmaceutical-manufacturing-changes\/","title":{"rendered":"FDA\u5c31\u66f4\u65b0SUPAC\u6307\u5357\u542f\u52a8\u516c\u4f17\u54a8\u8be2\u2026\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u5728\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67083\u65e5<\/span><\/b><span data-contrast=\"auto\">\uff0c \u8fd9\u00a0<\/span><b><span data-contrast=\"auto\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5ba3\u5e03\u5c31\u5176\u8fdb\u884c\u516c\u4f17\u54a8\u8be2\uff0c\u5f81\u6c42\u610f\u89c1\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u89c4\u6a21\u5316\u751f\u4ea7\u548c\u4e0a\u5e02\u540e\u53d8\u66f4\uff08SUPAC\uff09\u6307\u5357<\/span><\/b><span data-contrast=\"auto\">\u00a0\u9488\u5bf9\u836f\u54c1\u3002\u6b64\u6b21\u54a8\u8be2\u7684\u91cd\u70b9\u662f\u00a0<\/span><b><span data-contrast=\"auto\">\u5316\u5b66\u3001\u5236\u9020\u548c\u63a7\u5236 (CMC)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u8981\u6c42\u548c\u76ee\u6807\u662f\u8bc4\u4f30\u73b0\u6709\u7684 SUPAC \u6307\u5bfc\u6587\u4ef6\u662f\u5426\u4ecd\u7136\u5177\u6709\u76f8\u5173\u6027\uff0c\u4ee5\u53ca\u662f\u5426\u7b26\u5408\u5f53\u524d\u7684\u79d1\u5b66\u548c\u76d1\u7ba1\u6807\u51c6\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u8be5\u5ba1\u67e5\u6db5\u76d6\u4e86SUPAC\u6307\u5357\u00a0<\/span><b><span data-contrast=\"auto\">\u7acb\u5373\u53d1\u5e03<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">\u4fee\u6539\u7248<\/span><\/b><span data-contrast=\"auto\">\uff0c \u548c\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u65e0\u83cc\u534a\u56fa\u4f53\u5242\u578b<\/span><\/b><span data-contrast=\"auto\">, \u4ee5\u53ca\u4e0e\u6b64\u76f8\u5173\u7684\u53d8\u5316\u00a0<\/span><b><span data-contrast=\"auto\">\u5236\u9020\u8bbe\u5907<\/span><\/b><span data-contrast=\"auto\">. \u6b22\u8fce\u5236\u836f\u884c\u4e1a\u7684\u5229\u76ca\u76f8\u5173\u8005\u63d0\u4ea4\u53cd\u9988\u610f\u89c1\uff0c\u4ee5\u5e2e\u52a9\u786e\u5b9a\u662f\u5426\u5e94\u5728\u66f4\u65b0\u540e\u7684\u6307\u5357\u4e2d\u52a0\u5165\u4fee\u8ba2\u3001\u6f84\u6e05\u6216\u5176\u4ed6\u4e3b\u9898\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u54a8\u8be2\u671f\u6301\u7eed\u5f00\u653e\u81f3\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e746\u67081\u65e5<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<div class=\"row\"  id=\"row-1433992878\">\n\n\t<div id=\"col-138266951\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-776683273\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-776683273 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-90049304\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-90049304 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">FDA\u6b63\u5728\u5f81\u6c42\u5bf9\u4ee5\u4e0b\u5185\u5bb9\u7684\u53cd\u9988\u610f\u89c1\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u5b9e\u7528\u6027\u3001\u6e05\u6670\u5ea6\u548c\u9002\u7528\u6027<\/span><\/b><span data-contrast=\"auto\">\u00a0SUPAC \u5f53\u524d\u6307\u5357\u6d89\u53ca\u836f\u54c1\u751f\u4ea7\u89c4\u6a21\u6269\u5927\u548c\u4e0a\u5e02\u540e\u53d8\u66f4\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u672c\u6b21\u5ba1\u67e5\u4e13\u95e8\u8003\u5bdf\u73b0\u6709\u6307\u5bfc\u6587\u4ef6\u662f\u5426\u7b26\u5408\u4ee5\u4e0b\u8981\u6c42\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u7acb\u5373\u53d1\u5e03<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">\u4fee\u6539\u7248<\/span><\/b><span data-contrast=\"auto\">\uff0c \u548c\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u65e0\u83cc\u534a\u56fa\u4f53\u5242\u578b<\/span><\/b><span data-contrast=\"auto\">\u00a0\u7ee7\u7eed\u652f\u6301\u5bf9CMC\u53d8\u66f4\u8fdb\u884c\u6709\u6548\u7684\u76d1\u7ba1\u3002\u8be5\u673a\u6784\u8fd8\u5728\u8bc4\u4f30\u4e0e\u6b64\u76f8\u5173\u7684\u6307\u5bfc\u610f\u89c1\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u751f\u4ea7\u8bbe\u5907\u53d8\u66f4<\/span><\/b><span data-contrast=\"auto\">, \u8fd9\u53ef\u80fd\u4f1a\u5bf9\u751f\u4ea7\u6d41\u7a0b\u548c\u8d28\u91cf\u4f53\u7cfb\u4ea7\u751f\u5f71\u54cd\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u6b64\u5916\uff0cFDA\u6b63\u5728\u8003\u8651\u8fd9\u4e9b\u6587\u4ef6\u662f\u5426\u4ecd\u7136\u7b26\u5408\u6700\u65b0\u7684\u56fd\u9645\u76d1\u7ba1\u6846\u67b6\uff0c\u5c24\u5176\u662f\u5728\u2026\u2026\u65b9\u9762\u3002\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)\u5173\u4e8e\u8d28\u91cf\u98ce\u9669\u7ba1\u7406<\/span><\/b><span data-contrast=\"auto\">\u00a0\u548c\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12 \u5173\u4e8e\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406<\/span><\/b><span data-contrast=\"auto\">. \u8be5\u673a\u6784\u9f13\u52b1\u5229\u76ca\u76f8\u5173\u8005\u5728\u5176\u73b0\u6709\u5de5\u4f5c\u4e2d\uff0c\u627e\u51fa\u5728\u89e3\u8bfb\u6216\u5b9e\u65bdSUPAC\u5efa\u8bae\u65b9\u9762\u9047\u5230\u7684\u6311\u6218\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u836f\u54c1\u8d28\u91cf\u4f53\u7cfb<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u884c\u4e1a\u53c2\u4e0e\u8005\u4e5f\u53ef\u80fd\u63d0\u51fa\u5efa\u8bae\u00a0<\/span><b><span data-contrast=\"auto\">\u65b0\u4e3b\u9898\u3001\u66f4\u65b0\u6216\u4fee\u8ba2<\/span><\/b><span data-contrast=\"auto\">\u00a0\u8fd9\u53ef\u4ee5\u63d0\u9ad8\u6307\u5bfc\u610f\u89c1\u7684\u76f8\u5173\u6027\uff0c\u540c\u65f6\u6709\u52a9\u4e8e\u51cf\u5c11\u76d1\u7ba1\u7684\u590d\u6742\u6027\u6216\u4e0d\u5fc5\u8981\u7684\u8d1f\u62c5\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-138266951 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1868423002\" 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>\u53cd\u9988\u622a\u6b62\u65e5\u671f<\/h2>\n\t<div id=\"gap-2087693878\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2087693878 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">\u6b22\u8fce\u5404\u5229\u76ca\u76f8\u5173\u65b9\u53c2\u52a0\u00a0<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW54403655 BCX0\">\u00a0\u5bf9FDA\u7684SUPAC\u6307\u5357\u5ba1\u67e5\u7684\u8bc4\u8bba\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">2026\u5e746\u67081\u65e5<\/span><\/span><\/strong><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\"><strong>.<\/strong> \u53ef\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u63d0\u4ea4\uff1a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">FDA\u6307\u5b9a\u7684\u7535\u5b50\u6216\u4e66\u9762\u6e20\u9053\u3002<\/span><\/span><span class=\"TextRun SCXW54403655 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW54403655 BCX0\">.<\/span><\/span><span class=\"EOP SCXW54403655 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1868423002 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1707207516\" 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-1755971948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1755971948 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">SUPAC \u6307\u5357\u5728\u754c\u5b9a\u5236\u836f\u4f01\u4e1a\u5982\u4f55\u7ba1\u7406\u65b9\u9762\u53d1\u6325\u7740\u91cd\u8981\u4f5c\u7528\u00a0<\/span><b><span data-contrast=\"auto\">\u6279\u51c6\u540e\u5236\u9020\u548c\u8d28\u91cf\u63a7\u5236\u6d41\u7a0b\u7684\u53d8\u66f4<\/span><\/b><span data-contrast=\"auto\">. \u901a\u8fc7\u5ba1\u67e5\u8fd9\u4e9b\u6587\u4ef6\uff0cFDA\u65e8\u5728\u786e\u4fdd\u5b83\u4eec\u53cd\u6620\u5b9e\u9645\u60c5\u51b5\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u73b0\u884c\u79d1\u5b66\u6807\u51c6\u3001\u57fa\u4e8e\u98ce\u9669\u7684\u76d1\u7ba1\u65b9\u6cd5\u4ee5\u53ca\u4e0e\u56fd\u9645\u6846\u67b6\u7684\u4e00\u81f4\u6027<\/span><\/b><span data-contrast=\"auto\">\u00a0\u4f8b\u5982\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q9(R1)<\/span><\/b><span data-contrast=\"auto\">\u00a0\u548c\u00a0<\/span><b><span data-contrast=\"auto\">ICH Q12<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u66f4\u65b0\u8fd9\u4e9b\u6307\u5357\u53ef\u80fd\u6709\u52a9\u4e8e\u63d0\u9ad8\u6548\u7387\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u76d1\u7ba1\u653f\u7b56\u7684\u6e05\u6670\u5ea6\u3001\u8d28\u91cf\u4f53\u7cfb\u7684\u6570\u5b57\u5316\u8f6c\u578b\u4ee5\u53ca\u836f\u54c1\u751f\u547d\u5468\u671f\u7684\u9ad8\u6548\u7ba1\u7406<\/span><\/b><span data-contrast=\"auto\">, \u540c\u65f6\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u5236\u9020\u5546\u4e0d\u5fc5\u8981\u7684\u76d1\u7ba1\u8d1f\u62c5\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1707207516 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-442675203\" 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-786678011\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-786678011 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u672c\u6b21\u54a8\u8be2\u5c24\u5176\u4e0e\u4ee5\u4e0b\u65b9\u9762\u76f8\u5173\uff1a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u6cd5\u89c4\u4e8b\u52a1\u56e2\u961f\u3001\u8d28\u91cf\u4fdd\u8bc1 (QA) \u4e13\u4e1a\u4eba\u5458\u3001\u751f\u4ea7\u548c CMC \u4e13\u5bb6\u4ee5\u53ca\u836f\u54c1\u5408\u89c4\u8d1f\u8d23\u4eba<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\"><strong>\u00a0<\/strong>\u8d1f\u8d23\u7ba1\u7406\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u89c4\u6a21\u5316\u6d3b\u52a8\u548c\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW159808703 BCX0\">\u6279\u51c6\u540e<\/span><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0\u53d8\u5316<\/span><\/span><\/strong><span class=\"TextRun SCXW159808703 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW159808703 BCX0\">\u00a0\u5728\u53d7\u76d1\u7ba1\u7684\u836f\u54c1\u751f\u4ea7\u73af\u5883\u4e2d\u3002.<\/span><\/span><span class=\"EOP SCXW159808703 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-442675203 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-715309456\" 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-370910186\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-370910186 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u5404\u7ec4\u7ec7\u5e94\u5ba1\u67e5\u5176\u5f53\u524d\u72b6\u51b5\u00a0<\/span><b><span data-contrast=\"auto\">\u7528\u4e8e\u7ba1\u7406\u89c4\u6a21\u5316\u751f\u4ea7\u548c\u83b7\u6279\u540e\u751f\u4ea7\u53d8\u66f4\u7684\u5185\u90e8\u7a0b\u5e8f<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6839\u636e\u73b0\u6709\u7684SUPAC\u6307\u5357\uff0c\u76d1\u7ba1\u548c\u8d28\u91cf\u56e2\u961f\u53ef\u4ee5\u8003\u8651\u786e\u5b9a\u4ee5\u4e0b\u9886\u57df\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u6f84\u6e05\u3001\u66f4\u65b0\u6216\u8865\u5145\u6307\u5bfc<\/span><\/b><span data-contrast=\"auto\">\u00a0\u53ef\u4ee5\u6539\u8fdb\u5b9e\u65bd\u6216\u964d\u4f4e\u64cd\u4f5c\u590d\u6742\u6027\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u516c\u53f8\u4e5f\u53ef\u4ee5\u901a\u8fc7\u534f\u8c03\u5408\u4f5c\u800c\u53d7\u76ca\u00a0<\/span><b><span data-contrast=\"auto\">\u76d1\u7ba1\u3001\u8d28\u91cf\u548c\u5236\u9020\u56e2\u961f\u4e4b\u95f4\u7684\u8de8\u804c\u80fd\u53cd\u9988<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5728\u5411FDA\u63d0\u4ea4\u610f\u89c1\u4e4b\u524d\uff0c\u5236\u5b9a\u4e00\u4efd\u5168\u9762\u7684\u56de\u5e94\u65b9\u6848\u3002\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e746\u67081\u65e5\u622a\u6b62\u65e5\u671f<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">\u968f\u7740\u76d1\u7ba1\u9884\u671f\u7684\u589e\u52a0\u00a0<\/span><b><span data-contrast=\"auto\">CMC\u751f\u547d\u5468\u671f\u7ba1\u7406\u548c\u57fa\u4e8e\u98ce\u9669\u7684\u53d8\u66f4\u63a7\u5236<\/span><\/b><span data-contrast=\"auto\">\u00a0\u968f\u7740\u76d1\u7ba1\u60c5\u62a5\u548c\u76d1\u63a7\u5de5\u5177\u7684\u4e0d\u65ad\u53d1\u5c55\uff0c\u8fd9\u4e9b\u5de5\u5177\u53ef\u4ee5\u5e2e\u52a9\u7ec4\u7ec7\u8ddf\u8e2a\u54a8\u8be2\u60c5\u51b5\u5e76\u9884\u6d4b\u6f5c\u5728\u7684\u76d1\u7ba1\u53d8\u5316\u3002.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\"><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\u65e8\u5728\u5e2e\u52a9\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u5168\u7403\u4f01\u4e1a\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u8be5\u5e73\u53f0\u7ed3\u5408\u4e86\u5148\u8fdb\u7684\u4eba\u5de5\u667a\u80fd\u6280\u672f\uff0c\u80fd\u591f\u5e2e\u52a9\u4f01\u4e1a\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002 <strong>\u4ee3\u7406\u4eba\u5de5\u667a\u80fd<\/strong> \u6709\u4e13\u5bb6\u53c2\u4e0e\u5176\u4e2d\uff0c, <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u6d1e\u5bdf\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u964d\u4f4e\u98ce\u9669\uff0c\u5e76\u52a0\u901f\u8fdb\u5165 160 \u591a\u4e2a\u56fd\u5bb6\u7684\u5e02\u573a\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<\/strong><\/a><\/span><strong>\u00a0<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-715309456 > .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-1880305818\">\n\n\t<div id=\"col-1701300222\" 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-384809958\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-384809958 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW116607224 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">FDA\u7684\u8981\u6c42\u662f\u4ec0\u4e48\uff1f\u00a0<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u53cd\u9988<\/span><span class=\"NormalTextRun SCXW116607224 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u5728SUPAC\u54a8\u8be2\u4e2d\uff1f<\/span><\/span><span class=\"EOP SCXW116607224 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-874830451\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-874830451 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u6b63\u5728\u5c31\u4ee5\u4e0b\u4e8b\u9879\u5f81\u6c42\u516c\u4f17\u610f\u89c1\uff1a<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u73b0\u6709SUPAC\u7684\u76f8\u5173\u6027\u3001\u6e05\u6670\u5ea6\u548c\u5b9e\u7528\u6027\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">\u6307\u5bfc<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0\u90a3\u4e2a\u5730\u5740\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u89c4\u6a21\u5316\u548c\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW27174500 BCX0\">\u6279\u51c6\u540e<\/span><span class=\"NormalTextRun SCXW27174500 BCX0\">\u00a0\u53d8\u5316<\/span><\/span><\/strong><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\"><strong>\u00a0<\/strong>\u5bf9\u4e8e\u836f\u54c1\u800c\u8a00\uff0c\u5c24\u5176\u662f\u5728\u4ee5\u4e0b\u65b9\u9762\uff1a\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">\u5316\u5b66\u3001\u5236\u9020\u548c\u63a7\u5236 (CMC)<\/span><\/span><span class=\"TextRun SCXW27174500 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW27174500 BCX0\">.<\/span><\/span><span class=\"EOP SCXW27174500 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1701300222 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-84759961\" 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 SCXW185224076 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW185224076 BCX0\" data-ccp-parastyle=\"heading 3\">SUPAC\u5ba1\u67e5\u6db5\u76d6\u54ea\u4e9b\u836f\u54c1\u7c7b\u522b\uff1f<\/span><\/span><span class=\"EOP SCXW185224076 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335559738&quot;:281,&quot;335559739&quot;:281}\">\u00a0<\/span><\/h4>\n\t<div id=\"gap-1862284017\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1862284017 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u6b64\u6b21\u54a8\u8be2\u6db5\u76d6SUPAC\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW232278638 BCX0\">\u6307\u5bfc<\/span><span class=\"NormalTextRun SCXW232278638 BCX0\">\u00a0\u4e3a\u4e86\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u7acb\u5373\u53d1\u5e03<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">,\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u4fee\u6539\u7248<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\uff0c \u548c\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u975e\u65e0\u83cc\u534a\u56fa\u4f53\u5242\u578b<\/span><\/span><\/strong><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\"><strong>,<\/strong> \u4ee5\u53ca\u4e0e\u6b64\u76f8\u5173\u7684\u6307\u5bfc\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">\u751f\u4ea7\u8bbe\u5907\u53d8\u66f4<\/span><\/span><span class=\"TextRun SCXW232278638 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW232278638 BCX0\">.<\/span><\/span><span class=\"EOP SCXW232278638 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335559738&quot;:240,&quot;335559739&quot;:240}\">\u00a0<\/span><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-84759961 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-239499261\" 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 SCXW132097625 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u622a\u6b62\u65e5\u671f\u662f\u4ec0\u4e48\u65f6\u5019\uff1f\u00a0<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u63d0\u4ea4<\/span><span class=\"NormalTextRun SCXW132097625 BCX0\" data-ccp-parastyle=\"heading 3\">\u00a0\u5bf9FDA\u6709\u4f55\u8bc4\u8bba\uff1f<\/span><\/span><span class=\"EOP SCXW132097625 BCX0\" 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