{"id":9350,"date":"2026-01-06T14:35:16","date_gmt":"2026-01-06T06:35:16","guid":{"rendered":"https:\/\/regask.com\/?p=9350"},"modified":"2026-01-06T14:35:16","modified_gmt":"2026-01-06T06:35:16","slug":"%e6%ac%a7%e6%b4%b2%e8%8d%af%e5%93%81%e7%ae%a1%e7%90%86%e5%b1%80-ema-%e6%9b%b4%e6%96%b0%e4%ba%86%e4%b8%8a%e5%b8%82%e5%90%8e%e5%8f%98%e6%9b%b4%e7%ae%a1%e7%90%86%e5%8d%8f%e8%ae%ae%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/ema-updates-guidance-on-post-approval-change-management-protocols-to-strengthen-medicinal-product-lifecycle-compliance\/","title":{"rendered":"EMA\u66f4\u65b0\u4e0a\u5e02\u540e\u53d8\u66f4\u7ba1\u7406\u6307\u5357\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2025\u5e7412\u670811\u65e5,<\/strong> \u8fd9 <a href=\"https:\/\/www.ema.europa.eu\/en\/homepage\"><strong>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/strong><\/a> \u5df2\u53d1\u5e03 <strong>\u4fee\u8ba2\u540e\u7684\u4e0a\u5e02\u540e\u53d8\u66f4\u7ba1\u7406\u534f\u8bae\uff08PACMP\uff09\u6307\u5357,<\/strong> \u66f4\u65b0\u6b27\u76df\u8303\u56f4\u5185\u4eba\u7528\u836f\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u6846\u67b6\u3002\u8be5\u6307\u5357\u7eb3\u5165\u4e86\u81ea2012\u5e74\u4ee5\u6765\u79ef\u7d2f\u7684\u76d1\u7ba1\u7ecf\u9a8c\uff0c\u5e76\u4e0e\u4ee5\u4e0b\u65b9\u9762\u4fdd\u6301\u4e00\u81f4\uff1a <strong>\u66f4\u65b0\u540e\u7684\u6b27\u76df\u53d8\u66f4\u6cd5\u89c4\u548c\u6307\u5357,<\/strong> \u751f\u6548\u65e5\u671f <strong>2026\u5e741\u670815\u65e5\u3002.<\/strong> \u5b83\u9002\u7528\u4e8e\u6240\u6709\u4eba\u7c7b\u836f\u54c1\uff0c\u91cd\u70b9\u5728\u4e8e\u5b9e\u73b0\u5bf9\u5408\u683c\u8d28\u91cf\u53d8\u66f4\u8fdb\u884c\u66f4\u5feb\u3001\u66f4\u53ef\u9884\u6d4b\u7684\u76d1\u7ba1\u5904\u7406\u3002.<\/p>\n<div class=\"row\"  id=\"row-864165637\">\n\n\t<div id=\"col-393934413\" 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-2131855196\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2131855196 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u6307\u5357\u7684\u89e3\u91ca<\/h2>\n\t<div id=\"gap-104653809\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-104653809 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4fee\u8ba2\u540e\u7684\u6307\u5357\u660e\u786e\u6307\u51fa\uff1a <strong>PACMP \u53ef\u4ee5\u63d0\u4ea4<\/strong> \u4f5c\u4e3a\u521d\u59cb\u9636\u6bb5\u7684\u4e00\u90e8\u5206 <strong><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/marketing-authorisation\">\u4e0a\u5e02\u8bb8\u53ef<\/a> \u5e94\u7528\u7a0b\u5e8f\uff08MAA\uff09\uff0c,<\/strong> \u4f5c\u4e3a\u4e00\u4e2a <strong>\u7ebf\u8def\u5ef6\u957f\u7ebf\uff0c,<\/strong> \u6216\u901a\u8fc7 <strong>II \u578b\u53d8\u5f02<\/strong>, \u8fd9\u4f7f\u5f97\u516c\u53f8\u80fd\u591f\u9884\u5148\u5b9a\u4e49\u672a\u6765\u8d28\u91cf\u53d8\u66f4\u7684\u7b56\u7565\u3002\u5b83\u89e3\u91ca\u8bf4\uff0c\u6839\u636e\u5df2\u6279\u51c6\u7684 PACMP \u5b9e\u65bd\u7684\u53d8\u66f4\u901a\u5e38\u4f7f\u7528\u4ee5\u4e0b\u65b9\u5f0f\u8fdb\u884c\u5904\u7406\u3002 <strong>\u98ce\u9669\u8f83\u4f4e\u7684\u53d8\u5f02\u7c7b\u578b\uff0c\u4f8b\u5982 IA \u578b\u3001IAIN \u578b\u6216 IB \u578b\uff0c,<\/strong> \u800c\u4e0d\u662f\u6807\u51c6\u53d8\u5f02\u9014\u5f84\u4e2d\u4f7f\u7528\u7684\u66f4\u590d\u6742\u7684\u7a0b\u5e8f\u3002.<\/p>\n<p>\u8be5\u6307\u5357\u8fd8\u786e\u8ba4\u4e86\uff1a <strong>\u5141\u8bb8\u591a\u7528\u9014PACMP\uff0c,<\/strong> \u524d\u63d0\u662f\u9884\u5148\u8bbe\u5b9a\u7684\u6761\u4ef6\u548c\u9a8c\u6536\u6807\u51c6\u4fdd\u6301\u4e0d\u53d8\u3002\u7136\u800c\uff0c\u5b83\u660e\u786e\u6307\u51fa\uff1a <strong>PACMP \u4e0d\u80fd\u4f7f\u7528<\/strong> \u5bf9\u4e8e\u9700\u8981\u4e34\u5e8a\u6216\u975e\u4e34\u5e8a\u7684\u53d8\u66f4 <strong>\u6570\u636e\u8bc4\u4f30<\/strong> \u6216\u56e0\u53d8\u5316\u672c\u8eab\u800c\u5bfc\u81f4<strong> \u5728\u5ef6\u4f38\u7ebf\u4e0a\u3002.\u00a0<\/strong><\/p>\n<p>\u4e3a\u4e86\u652f\u6301\u900f\u660e\u5ea6\u548c\u751f\u547d\u5468\u671f\u76d1\u7ba1\uff0cEMA \u8981\u6c42\uff1a <strong>\u6240\u6709PACMP\u5747\u5e94\u5217\u4e8e\u6863\u6848\u7684\u6a21\u57573.2.R\u4e2d\uff0c,<\/strong> \u786e\u4fdd\u5bf9\u5df2\u6279\u51c6\u7684\u53d8\u66f4\u7b56\u7565\u8fdb\u884c\u6e05\u6670\u7684\u8bb0\u5f55\u3002\u6b64\u5916\uff0c\u4fee\u8ba2\u540e\u7684 <strong>\u6b27\u76df\u53d8\u66f4\u6307\u5357\u4ec5\u9002\u7528\u4e8e2026\u5e741\u670815\u65e5\u6216\u4e4b\u540e\u63d0\u4ea4\u7684\u5b9e\u65bd\u6027\u53d8\u66f4\u3002,<\/strong> \u4e3a\u76d1\u7ba1\u56e2\u961f\u5236\u5b9a\u660e\u786e\u7684\u8fc7\u6e21\u65f6\u95f4\u8868\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-393934413 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1835752821\" 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-1195688594\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1195688594 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>\u76ee\u524d\u5c1a\u672a\u8bbe\u5b9a\u53cd\u9988\u6216\u54a8\u8be2\u622a\u6b62\u65e5\u671f\u3002<\/strong> \u672c\u6b21\u6307\u5357\u66f4\u65b0\u5185\u5bb9\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1835752821 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-830677138\" 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-1424702459\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1424702459 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u6b21\u66f4\u65b0\u63d0\u4f9b\u4e86\u66f4\u5927\u7684 <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u56f4\u7ed5 PACMP \u7684\u4f7f\u7528\uff0c\u63d0\u4f9b\u652f\u6301 <strong>\u6570\u5b57\u5bf9\u51c6<\/strong> \u901a\u8fc7\u66f4\u65b0\u6b27\u76df\u5dee\u5f02\u5316\u6846\u67b6\u5e76\u52a0\u4ee5\u6539\u8fdb <strong>\u6548\u7387<\/strong> \u901a\u8fc7\u4f7f\u4f4e\u98ce\u9669\u7684\u8d28\u91cf\u53d8\u66f4\u9075\u5faa\u53ef\u9884\u6d4b\u7684\u8def\u5f84\uff0c\u8be5\u6307\u5357\u5c06\u8303\u56f4\u9650\u5236\u5728\u65e0\u9700\u4e34\u5e8a\u6216\u975e\u4e34\u5e8a\u8bc4\u4f30\u7684\u53d8\u66f4\u4e0a\uff0c\u4ece\u800c\u5728\u4fdd\u6301\u76d1\u7ba1\u4e25\u683c\u6027\u7684\u540c\u65f6\uff0c\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u4ea7\u54c1\u751f\u547d\u5468\u671f\u7ba1\u7406\u4e2d\u4e0d\u5fc5\u8981\u7684\u884c\u653f\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-830677138 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1236761668\" 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>\u6b64\u66f4\u65b0\u9002\u7528\u4e8e\u54ea\u4e9b\u7528\u6237<\/h2>\n\t<div id=\"gap-591635030\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-591635030 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4ed6\u7684\u6307\u5bfc\u610f\u89c1\u5bf9\u2026\u2026\u5f88\u6709\u610f\u4e49 <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001CMC\u3001,<\/strong> \u548c <strong>\u76d1\u7ba1\u8fd0\u8425<\/strong> \u8d1f\u8d23\u7ba1\u7406\u6b27\u76df\u5883\u5185\u4eba\u7528\u836f\u54c1\u7684\u4e0a\u5e02\u540e\u53d8\u66f4\u3001\u6863\u6848\u7ef4\u62a4\u548c\u751f\u547d\u5468\u671f\u89c4\u5212\u7684\u56e2\u961f\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1236761668 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-812010582\" 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-278136010\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-278136010 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5404\u7ec4\u7ec7\u5e94\u5ba1\u67e5\u73b0\u6709\u548c\u8ba1\u5212\u4e2d\u7684\u4e8b\u9879 <strong>PACMPs<\/strong> \u786e\u8ba4\u4e0e\u4fee\u8ba2\u540e\u7684EMA\u6307\u5357\u548c\u66f4\u65b0\u540e\u7684\u6307\u5357\u4fdd\u6301\u4e00\u81f4 <strong>\u6b27\u76df\u53d8\u66f4\u6761\u4f8b\u3002.<\/strong> \u76d1\u7ba1\u56e2\u961f\u5e94\u786e\u4fddPACMP\u6e05\u5355\u5f97\u5230\u51c6\u786e\u7ef4\u62a4\u3002 <strong>\u6a21\u5757 3.2.R<\/strong> \u5e76\u534f\u8c03\u5404\u804c\u80fd\u90e8\u95e8\uff0c\u4e3a\u5b9e\u65bd\u63d0\u4ea4\u7684\u53d8\u66f4\u505a\u597d\u51c6\u5907\u3002 <strong>2026\u5e741\u670815\u65e5<\/strong> \u5411\u524d\u3002.<\/p>\n<p>\u5728\u76d1\u7ba1\u56e2\u961f\u6839\u636e\u4fee\u8ba2\u540e\u7684\u6846\u67b6\u8bc4\u4f30 PACMP \u8d44\u683c\u3001\u53d8\u66f4\u9014\u5f84\u548c\u6587\u4ef6\u51c6\u5907\u60c5\u51b5\u65f6\uff0c, <a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/a> \u80fd\u591f\u652f\u6301\u6301\u7eed\u76d1\u63a7\u548c\u7ed3\u6784\u5316\u5b9e\u65bd\u3002.<\/p>\n<p><strong><a href=\"https:\/\/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\u4f01\u4e1a\uff0c\u4f7f\u5176\u80fd\u591f\u79ef\u6781\u5e94\u5bf9\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u5728\u5185\u7684\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u590d\u6742\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u7ed3\u5408\u5148\u8fdb\u7684\u6280\u672f\uff0c <strong>\u4ee3\u7406\u4eba\u5de5\u667a\u80fd<\/strong> \u6709\u4e13\u5bb6\u53c2\u4e0e\u5176\u4e2d\uff0c, <a href=\"https:\/\/regask.com\/zh\/\">RegASK<\/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 157 \u591a\u4e2a\u56fd\u5bb6\u7684\u5e02\u573a\u3002. <a href=\"https:\/\/regask.com\/zh\/%e4%ba%a7%e5%93%81\/\">\u4e86\u89e3\u66f4\u591a<\/a> \u6216\u8005 <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><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-812010582 > .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-1494627956\">\n\n\t<div id=\"col-1322047227\" 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-1798606471\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1798606471 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>\u4ec0\u4e48\u662f\u5ba1\u6279\u540e\u53d8\u66f4\u7ba1\u7406\u534f\u8bae\uff08PACMP\uff09\uff1f<\/h4>\n\t<div id=\"gap-791937487\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-791937487 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4e00\u4e2a <strong>PACMP<\/strong> 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