{"id":9626,"date":"2026-03-11T15:04:43","date_gmt":"2026-03-11T07:04:43","guid":{"rendered":"https:\/\/regask.com\/?p=9626"},"modified":"2026-03-11T15:04:43","modified_gmt":"2026-03-11T07:04:43","slug":"fda%e5%8f%91%e5%b8%83%e5%85%b3%e4%ba%8e%e4%bd%bf%e7%94%a8%e7%9c%9f%e5%ae%9e%e4%b8%96%e7%95%8c%e6%95%b0%e6%8d%ae%e8%bf%9b%e8%a1%8c%e8%8d%af%e7%89%a9%e5%92%8c%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-issues-final-guidance-on-non-interventional-studies-using-real-world-data-for-drug-and-biologic-safety\/","title":{"rendered":"FDA\u53d1\u5e03\u5173\u4e8e\u975e\u5e72\u9884\u6027\u7814\u7a76\u7684\u6700\u7ec8\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p><span data-contrast=\"auto\">\u5728\u00a0<\/span><b><span data-contrast=\"auto\">2026\u5e743\u67084\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\u53d1\u5e03\u00a0<\/span><b><span data-contrast=\"auto\">\u6700\u7ec8\u6307\u5357<\/span><\/b><span data-contrast=\"auto\">\u00a0\u6982\u8ff0\u00a0<\/span><b><span data-contrast=\"auto\">\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e (RWD) \u7684\u975e\u5e72\u9884\u6027\u7814\u7a76\u7684\u89c4\u5212\u3001\u8bbe\u8ba1\u3001\u5206\u6790\u548c\u62a5\u544a\u7684\u4e00\u822c\u539f\u5219<\/span><\/b><span data-contrast=\"auto\">\u00a0\u8bc4\u4f30\u836f\u54c1\u5b89\u5168\u6027\u3002\u8be5\u6307\u5357\u9002\u7528\u4e8e\u00a0<\/span><b><span data-contrast=\"auto\">\u836f\u54c1\u3001\u75ab\u82d7\u548c\u751f\u7269\u5236\u54c1<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e76\u786e\u7acb\u76d1\u7ba1\u9884\u671f\u00a0<\/span><b><span data-contrast=\"auto\">\u4e0a\u5e02\u540e\u5b89\u5168\u6027\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">\u00a0\u7531\u5236\u836f\u548c\u751f\u7269\u5236\u54c1\u8d5e\u52a9\u5546\u8fdb\u884c\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\u6587\u4ef6\u89c4\u8303\u4e86\u4f7f\u7528\u975e\u5e72\u9884\u6027\u7814\u7a76\u65f6\u5e94\u5982\u4f55\u8fdb\u884c\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u771f\u5b9e\u4e16\u754c\u7684\u6570\u636e\u6e90\uff0c\u4f8b\u5982\u7535\u5b50\u5065\u5eb7\u8bb0\u5f55\u548c\u4fdd\u9669\u7d22\u8d54<\/span><\/b><span data-contrast=\"auto\">, \u5b83\u660e\u786e\u4e86\u7814\u7a76\u8bbe\u8ba1\u3001\u65b9\u6cd5\u548c\u62a5\u544a\u89c4\u8303\uff0c\u53d6\u4ee3\u4e86\u4e4b\u524d\u7684\u6307\u5357\u8349\u6848\u3002\u00a0<\/span><b><span data-contrast=\"auto\">\u64a4\u56deFDA\u4e8e2013\u5e745\u6708\u53d1\u5e03\u7684\u5173\u4e8e\u4f7f\u7528\u7535\u5b50\u533b\u7597\u6570\u636e\u96c6\u8fdb\u884c\u836f\u7269\u6d41\u884c\u75c5\u5b66\u5b89\u5168\u6027\u7814\u7a76\u7684\u6307\u5bfc\u610f\u89c1<\/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-1198100453\">\n\n\t<div id=\"col-1321358260\" 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-1357578757\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1357578757 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1844710600\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1844710600 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u6700\u7ec8\u6307\u5357\u5b9a\u4e49\u4e86\u00a0<\/span><b><span data-contrast=\"auto\">\u975e\u5e72\u9884\u6027\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">\u00a0\u8fd9\u4e9b\u7814\u7a76\u65b9\u6cd5\u65e8\u5728\u89c2\u5bdf\u7ed3\u679c\uff0c\u800c\u4e0d\u6307\u5b9a\u5177\u4f53\u7684\u6cbb\u7597\u6216\u5e72\u9884\u63aa\u65bd\u3002\u8fd9\u4e9b\u7814\u7a76\u4f9d\u8d56\u4e8e\u5728\u65e5\u5e38\u533b\u7597\u4fdd\u5065\u670d\u52a1\u4e2d\u6536\u96c6\u7684\u771f\u5b9e\u4e16\u754c\u6570\u636e\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\">FDA\u5efa\u8bae\u7533\u529e\u8005\u9996\u5148\u2026\u2026\u00a0<\/span><b><span data-contrast=\"auto\">\u660e\u786e\u63d0\u51fa\u7814\u7a76\u95ee\u9898<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e76\u786e\u5b9a\u80fd\u591f\u652f\u6301\u53ef\u9760\u5b89\u5168\u8bc4\u4f30\u7684\u9002\u5f53\u771f\u5b9e\u4e16\u754c\u6570\u636e\u6e90\u3002\u8be5\u6307\u5357\u8fd8\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u5fc5\u8981\u6027\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u7cbe\u786e\u5b9a\u4e49\u7814\u7a76\u53d8\u91cf\u548c\u7ec8\u70b9\u3002<\/span><\/b><span data-contrast=\"auto\">, \u786e\u4fdd\u6570\u636e\u96c6\u548c\u5206\u6790\u65b9\u6cd5\u9002\u5408\u9884\u671f\u7684\u5b89\u5168\u8bc4\u4f30\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\uff0c\u8be5\u6587\u4ef6\u8fd8\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u65b9\u9762\u7684\u91cd\u8981\u6027\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u89e3\u51b3\u504f\u501a\u548c\u6df7\u6742\u56e0\u7d20<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5728\u7814\u7a76\u8bbe\u8ba1\u548c\u5206\u6790\u8fc7\u7a0b\u4e2d\uff0c\u7533\u529e\u65b9\u5e94\u91c7\u7528\u76f8\u5173\u65b9\u6cd5\uff0c\u8bc6\u522b\u3001\u8bc4\u4f30\u5e76\u51cf\u8f7b\u53ef\u80fd\u5f71\u54cd\u5b89\u5168\u6027\u7ed3\u8bba\u7684\u6f5c\u5728\u504f\u501a\u6765\u6e90\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\">FDA\u8fdb\u4e00\u6b65\u6982\u8ff0\u4e86\u5bf9\u4ee5\u4e0b\u65b9\u9762\u7684\u671f\u671b\uff1a\u00a0<\/span><b><span data-contrast=\"auto\">\u900f\u660e\u7684\u7814\u7a76\u6587\u6863\u548c\u5168\u9762\u7684\u62a5\u544a<\/span><\/b><span data-contrast=\"auto\">, \u5305\u62ec\u5bf9\u7814\u7a76\u4e2d\u4f7f\u7528\u7684\u65b9\u6cd5\u3001\u6570\u636e\u6765\u6e90\u548c\u5206\u6790\u65b9\u6cd5\u7684\u8be6\u7ec6\u63cf\u8ff0\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-1321358260 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-498809543\" 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>\u751f\u6548\u65e5\u671f<\/h2>\n\t<div id=\"gap-2145163229\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2145163229 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u8fd9\u00a0<\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">FDA\u5173\u4e8e\u4f7f\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e\u8fdb\u884c\u975e\u5e72\u9884\u6027\u7814\u7a76\u7684\u6700\u7ec8\u6307\u5357<\/span><\/span><\/strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u00a0\u6210\u4e3a\u00a0<\/span><\/span><span class=\"TextRun MacChromeBold SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">\u6709\u6548 <strong>2026\u5e743\u67084\u65e5<\/strong><\/span><\/span><strong><span class=\"TextRun SCXW15748117 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW15748117 BCX0\">.<\/span><\/span><span class=\"EOP SCXW15748117 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-498809543 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-735542906\" 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-1252802087\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1252802087 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW234709501 BCX0\">\u672c\u6b21\u66f4\u65b0\u63d0\u4f9b<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW234709501 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span 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BCX0\">\u00a0\u540c\u65f6\u80fd\u591f\u6709\u6548\u5229\u7528\u73b0\u6709\u533b\u7597\u4fdd\u5065\u6570\u636e\u6e90\u3002.<\/span><\/span><span class=\"EOP SCXW234709501 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-735542906 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-322986010\" 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-1892630741\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1892630741 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW75709743 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW75709743 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clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-640887601 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span data-contrast=\"auto\">\u5f00\u5c55\u7684\u7ec4\u7ec7\u00a0<\/span><b><span data-contrast=\"auto\">\u5229\u7528\u771f\u5b9e\u4e16\u754c\u6570\u636e\u8fdb\u884c\u7684\u975e\u5e72\u9884\u6027\u5b89\u5168\u6027\u7814\u7a76<\/span><\/b><span data-contrast=\"auto\">\u00a0\u5e94\u5ba1\u67e5\u5f53\u524d\u7684\u7814\u7a76\u65b9\u6848\u548c\u65b9\u6cd5\uff0c\u4ee5\u786e\u4fdd\u5176\u7b26\u5408FDA\u66f4\u65b0\u540e\u7684\u8981\u6c42\u3002\u5229\u76ca\u76f8\u5173\u65b9\u8fd8\u5e94\u8bc4\u4f30\u76f8\u5173\u90e8\u95e8\u7684\u6587\u6863\u8bb0\u5f55\u89c4\u8303\u548c\u62a5\u544a\u6d41\u7a0b\uff0c\u4ee5\u786e\u8ba4\u7814\u7a76\u8bbe\u8ba1\u3001\u6570\u636e\u9009\u62e9\u65b9\u6cd5\u548c\u5206\u6790\u65b9\u6cd5\u7b26\u5408\u65b0\u6807\u51c6\u3002.<\/span><span 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