{"id":9485,"date":"2026-02-16T16:20:31","date_gmt":"2026-02-16T08:20:31","guid":{"rendered":"https:\/\/regask.com\/?p=9485"},"modified":"2026-02-16T16:20:31","modified_gmt":"2026-02-16T08:20:31","slug":"%e8%8b%b1%e5%9b%bd%e8%8d%af%e5%93%81%e5%92%8c%e4%bf%9d%e5%81%a5%e4%ba%a7%e5%93%81%e7%9b%91%e7%ae%a1%e7%bd%b2-mhra-%e5%8f%91%e5%b8%83%e4%ba%86%e5%85%b3%e4%ba%8e%e6%a0%b9%e6%8d%ae%e4%bf%ae%e8%ae%a2","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/uk-mhra-issues-guidance-on-pharmacovigilance-requirements-under-amended-cir-520-2012\/","title":{"rendered":"\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72\u53d1\u5e03\u836f\u7269\u8b66\u6212\u8981\u6c42\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u67089\u65e5,<\/strong> \u8fd9 <strong>\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u5c40\uff08MHRA\uff09<\/strong> \u82f1\u56fd\u836f\u54c1\u7ba1\u7406\u5c40\u53d1\u5e03\u4e86\u9488\u5bf9\u836f\u54c1\u4e0a\u5e02\u8bb8\u53ef\u6301\u6709\u4eba\u7684\u65b0\u6307\u5357\uff0c\u6982\u8ff0\u4e86\u5728\u4fee\u8ba2\u540e\u836f\u7269\u8b66\u6212\u8981\u6c42\u5c06\u5982\u4f55\u9002\u7528\u3002 <strong>\u59d4\u5458\u4f1a\u5b9e\u65bd\u6761\u4f8b\uff08CIR\uff09520\/2012\u3002.<\/strong> \u8be5\u6307\u5357\u53cd\u6620\u4e86\u6b27\u76df\u59d4\u5458\u4f1a\u7684\u91c7\u7eb3 <strong>\uff08\u6b27\u76df\uff092025\/1466 \u53f7\u6761\u4f8b,<\/strong> \u8be5\u4fee\u8ba2\u6848\u5bf9 CIR 520\/2012 \u8fdb\u884c\u4e86\u4fee\u6b63\uff0c\u5e76\u4e8e\u81ea[\u65e5\u671f]\u8d77\u751f\u6548\u3002 <strong>2026\u5e742\u670812\u65e5,<\/strong> \u90e8\u5206\u6761\u6b3e\u81ea[\u65e5\u671f]\u8d77\u751f\u6548 <strong>2025\u5e748\u670812\u65e5\u3002.<\/strong> \u6b64\u6b21\u66f4\u65b0\u5bf9\u6301\u6709\u80a1\u4efd\u7684\u7ec4\u7ec7\u5c24\u4e3a\u91cd\u8981\u3002 <strong>\u82f1\u56fd\u6388\u6743\u836f\u54c1<\/strong> \u5728\u4e0d\u540c\u7c7b\u522b\u4e0b <strong>\u6e29\u838e\u6846\u67b6\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1416899726\">\n\n\t<div id=\"col-627153752\" 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-1812228032\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1812228032 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1744253290\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1744253290 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u89e3\u91ca\u8bf4\uff1a <strong>CIR 520\/2012<\/strong> \u5df2\u7531\u2026\u2026\u6b63\u5f0f\u4fee\u8ba2 <strong>\uff08\u6b27\u76df\uff092025\/1466 \u53f7\u6761\u4f8b,<\/strong> \u5bf9\u836f\u7269\u8b66\u6212\u8981\u6c42\u8fdb\u884c\u4fee\u6539\u3002\u5b9e\u65bd\u4e4b\u540e<strong> \u6e29\u838e\u6846\u67b6,<\/strong> \u82f1\u56fd\u6388\u6743\u7684\u836f\u54c1\u73b0\u5728\u88ab\u5f52\u7c7b\u4e3a\uff1a <strong>\u7b2c\u4e00\u7c7b<\/strong> \u6216\u8005 <strong>\u7b2c\u4e8c\u7c7b,<\/strong> \u5b83\u51b3\u5b9a\u4e86\u9002\u7528\u7684\u6cd5\u5f8b\u6846\u67b6\u3002.<\/p>\n<p>\u4ece <strong>2026\u5e742\u670812\u65e5\uff0cHMR 2012\u9644\u886812A<\/strong> \u4ee5\u53ca\u4fee\u8ba2\u540e\u7684\u7248\u672c <strong>CIR 520\/2012<\/strong> \u5728\u836f\u7269\u8b66\u6212\u4e49\u52a1\u65b9\u9762\uff0c\u4e24\u8005\u7684\u6cd5\u5f8b\u89c4\u5b9a\u5c06\u4e0d\u518d\u4e00\u81f4\u3002\u8fd9\u79cd\u5dee\u5f02\u610f\u5473\u7740\uff0c\u6839\u636e\u4ea7\u54c1\u7c7b\u522b\u548c\u4ea7\u54c1\u7ec4\u5408\u7ed3\u6784\u7684\u4e0d\u540c\uff0c\u53ef\u80fd\u9002\u7528\u4e0d\u540c\u7684\u8981\u6c42\u3002.<\/p>\n<p>\u4e3a\u4e86\u51cf\u5c11\u4e0d\u5fc5\u8981\u7684\u76d1\u7ba1\u8d1f\u62c5\uff0cMHRA\u6982\u8ff0\u4e86 <strong>\u52a1\u5b9e\u7684\u5408\u89c4\u65b9\u6cd5<\/strong>. \u5e02\u573a\u6388\u6743\u6301\u6709\u4eba <strong>\u6df7\u5408\u6295\u8d44\u7ec4\u5408<\/strong> \u540c\u65f6\u5305\u542b\u7b2c\u4e00\u7c7b\u548c\u7b2c\u4e8c\u7c7b\u4ea7\u54c1\u7684\u4ed3\u5e93\uff0c\u5efa\u8bae\u91c7\u7528\u4fee\u8ba2\u540e\u7684\u89c4\u5b9a\u3002 <strong>CIR 520\/2012<\/strong> \u9002\u7528\u4e8e\u6240\u6709\u82f1\u56fd\u6388\u6743\u4ea7\u54c1\u3002\u76f8\u6bd4\u4e4b\u4e0b\uff0c\u6301\u6709\u8005\u2026\u2026 <strong>\u7b2c\u4e00\u7c7b\u4ea7\u54c1<\/strong> <strong>\u4ec5\u6709\u7684<\/strong> \u53ef\u80fd\u7ee7\u7eed\u5173\u6ce8 <strong>HMR\u9644\u886812A\uff0c,<\/strong> \u9664\u975e\u4ed6\u4eec\u4e5f\u6301\u6709 <strong>\u6b27\u76df\u540c\u7b49\u6388\u6743<\/strong>, \u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u8fd8\u9700\u8003\u8651\u5176\u4ed6\u56e0\u7d20\u3002.<\/p>\n<p>MHRA\u8fd8\u6307\u51fa\uff0c\u672a\u6765\u7684\u66f4\u65b0\u5c06\u2026\u2026 <strong>HMR 2012 \u9644\u8868 12A<\/strong> \u53ef\u4ee5\u8003\u8651\u66f4\u597d\u5730\u53cd\u6620\u5bf9\u4ee5\u4e0b\u5185\u5bb9\u6240\u505a\u7684\u4fee\u6539\uff1a <strong>CIR 520\/2012\uff0c,<\/strong> \u5c3d\u7ba1\u76ee\u524d\u5c1a\u672a\u786e\u8ba4\u4efb\u4f55\u53d8\u66f4\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-627153752 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-163711860\" 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-1746859258\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1746859258 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4fee\u8ba2\u540e\u7684 <strong>\u59d4\u5458\u4f1a\u5b9e\u65bd\u6761\u4f8b\uff08CIR\uff09520\/2012\uff0c,<\/strong> \u7ecf\u4fee\u8ba2 <strong>\uff08\u6b27\u76df\uff092025\/1466 \u53f7\u6761\u4f8b\u81ea 2026 \u5e74 2 \u6708 12 \u65e5\u8d77\u751f\u6548\u3002.<\/strong> \u7136\u800c\uff0c, <strong>\u7b2c 1(7) \u6761\u548c\u7b2c 1(9) \u6761<\/strong> \u4fee\u8ba2\u6761\u4f8b <strong>\u751f\u6548\u65e5\u671f\u8f83\u65e9\uff0c\u4e3a 2025 \u5e74 8 \u6708 12 \u65e5\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-163711860 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1828621452\" 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-5773608\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-5773608 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6b21\u66f4\u65b0\u5f15\u5165\u4e86 <strong>\u82f1\u56fd\u548c\u6b27\u76df\u836f\u7269\u8b66\u6212\u6cd5\u5f8b\u6846\u67b6\u4e0d\u4e00\u81f4\uff0c,<\/strong> \u4e3a\u5408\u89c4\u89c4\u5212\u521b\u9020\u5b9e\u9645\u610f\u4e49\u3002MHRA \u7684\u52a1\u5b9e\u65b9\u6cd5\u65e8\u5728\u63d0\u4f9b\u652f\u6301 <strong>\u76d1\u7ba1\u6e05\u6670\u5ea6\u3001\u8fd0\u8425\u6548\u7387,<\/strong> \u548c <strong>\u6570\u5b57\u5bf9\u51c6,<\/strong> \u8fd9\u8fd8\u8981\u6c42\u5404\u7ec4\u7ec7\u8c28\u614e\u7ba1\u7406\u6d41\u7a0b\uff0c\u4ee5\u907f\u514d\u8bef\u7528\u76f8\u5173\u8981\u6c42\u3002\u8fd9\u4e9b\u53d8\u5316\u53ef\u80fd\u9700\u8981\u5bf9\u836f\u7269\u8b66\u6212\u7cfb\u7edf\u3001\u6cbb\u7406\u7ed3\u6784\u548c\u5185\u90e8\u7a0b\u5e8f\u8fdb\u884c\u6709\u9488\u5bf9\u6027\u7684\u66f4\u65b0\uff0c\u5c24\u5176\u5bf9\u4e8e\u4ea7\u54c1\u7ec4\u5408\u590d\u6742\u6216\u6df7\u5408\u7684\u7ec4\u7ec7\u800c\u8a00\u66f4\u662f\u5982\u6b64\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1828621452 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1730338002\" 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-1291682324\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1291682324 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6307\u5357\u9002\u7528\u4e8e <strong>\u836f\u7269\u8b66\u6212\u3001\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u5408\u89c4\u6027,<\/strong> \u6211<strong>\u6570\u5b57\u6cbb\u7406\u56e2\u961f<\/strong> \u8d1f\u8d23\u7ba1\u7406\u82f1\u56fd\u6388\u6743\u7684\u836f\u54c1\u548c\u8de8\u53f8\u6cd5\u7ba1\u8f96\u533a\u7684\u76d1\u7ba1\u4e49\u52a1\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1730338002 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-133835584\" 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-1033536246\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1033536246 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5404\u7ec4\u7ec7\u5e94\u5ba1\u67e5\u5176 <strong>\u82f1\u56fd\u4ea7\u54c1\u7ec4\u5408<\/strong> \u786e\u8ba4\u4ea7\u54c1\u662f\u5426\u5c5e\u4e8e <strong>\u7b2c\u4e00\u7c7b\u6216\u7b2c\u4e8c\u7c7b<\/strong> \u5e76\u8bc4\u4f30\u662f\u5426\u5b58\u5728\u4efb\u4f55 <strong>\u6b27\u76df\u540c\u7b49\u8bb8\u53ef\u8bc1<\/strong>. \u5185\u90e8\u836f\u7269\u8b66\u6212\u7a0b\u5e8f\u3001\u51b3\u7b56\u6846\u67b6\u548c\u6cbb\u7406\u6a21\u5f0f\u5e94\u5bf9\u7167\u5df2\u660e\u786e\u9884\u671f\u8fdb\u884c\u68c0\u67e5\uff0c\u5e76\u4e8b\u5148\u8fdb\u884c\u8de8\u90e8\u95e8\u534f\u8c03\u3002 <strong>2026\u5e742\u670812\u65e5<\/strong> \u751f\u6548\u65e5\u671f\u65e8\u5728\u6700\u5927\u7a0b\u5ea6\u5730\u964d\u4f4e\u5408\u89c4\u98ce\u9669\u3002.<\/p>\n<p>\u968f\u7740\u76d1\u7ba1\u5dee\u5f02\u589e\u52a0\u8fd0\u8425\u590d\u6742\u6027\uff0c\u5efa\u7acb\u7ed3\u6784\u5316\u7684\u65b9\u6cd5\u6765\u76d1\u63a7\u53d8\u5316\u5e76\u8bc4\u4f30\u5176\u5f71\u54cd\u53d8\u5f97\u8d8a\u6765\u8d8a\u91cd\u8981\u3002. <strong><a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a> \u662f\u4e00\u4e2a\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u60c5\u62a5\u548c\u5de5\u4f5c\u6d41\u7f16\u6392\u5e73\u53f0<\/strong> \u5b83\u8d4b\u80fd\u5168\u7403\u7ec4\u7ec7\uff0c\u4f7f\u5176\u80fd\u591f\u79ef\u6781\u5e94\u5bf9\u5305\u62ec\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u4e0d\u65ad\u53d8\u5316\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u7ed3\u5408\u5148\u8fdb\u7684\u6280\u672f\uff0c <strong>\u4e13\u5bb6\u53c2\u4e0e\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd, <a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> \u63d0\u4f9b\u53ca\u65f6\u3001\u9884\u6d4b\u6027\u548c\u53ef\u64cd\u4f5c\u7684\u89c1\u89e3\uff0c\u5e2e\u52a9\u56e2\u961f\u7b80\u5316\u5408\u89c4\u6d41\u7a0b\uff0c\u5e76\u5728 160 \u591a\u4e2a\u56fd\u5bb6\/\u5730\u533a\u4fdd\u6301\u76d1\u7ba1\u3002.<strong> <a href=\"http:\/\/regask.com\/zh\/\">\u4e86\u89e3\u66f4\u591a<\/a><\/strong> \u6216\u8005 <strong><a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\">\u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002\u00a0<\/a><\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-133835584 > .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-1745424222\">\n\n\t<div id=\"col-1744128220\" 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-1916412915\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1916412915 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW240545805 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW240545805 BCX0\">\u4ec0\u4e48\u662f\u59d4\u5458\u4f1a\u5b9e\u65bd\u6761\u4f8b 520\/2012\uff1f<\/span><\/span><span class=\"EOP SCXW240545805 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-2130184066\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2130184066 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u8fd9\u662f\u4e00\u9879\u6b27\u76df\u6cd5\u89c4\uff0c\u5176\u4e2d\u8be6\u7ec6\u89c4\u5b9a\u4e86\u2026\u2026<strong>\u00a0<\/strong><\/span><\/span><strong><span class=\"TextRun MacChromeBold SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u836f\u7269\u8b66\u6212\u8981\u6c42<\/span><\/span><\/strong><span class=\"TextRun SCXW37803039 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0\u836f\u54c1\u8425\u9500\u4e49\u52a1\u00a0<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW37803039 BCX0\">\u6388\u6743<\/span><span class=\"NormalTextRun SCXW37803039 BCX0\">\u00a0\u6301\u6709\u8005\u3002.<\/span><\/span><span class=\"EOP SCXW37803039 BCX0\" 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