{"id":9712,"date":"2026-03-25T16:21:55","date_gmt":"2026-03-25T08:21:55","guid":{"rendered":"https:\/\/regask.com\/?p=9712"},"modified":"2026-03-26T14:34:30","modified_gmt":"2026-03-26T06:34:30","slug":"%e7%be%8e%e5%9b%bd%e9%a3%9f%e5%93%81%e8%8d%af%e5%93%81%e7%9b%91%e7%9d%a3%e7%ae%a1%e7%90%86%e5%b1%80%ef%bc%88fda%ef%bc%89%e3%80%81%e8%8b%b1%e5%9b%bd%e8%8d%af%e5%93%81%e5%92%8c%e4%bf%9d%e5%81%a5","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-mhra-and-health-canada-announce-joint-symposium-on-gcp-bioequivalence-and-pharmacovigilance\/","title":{"rendered":"\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA)\u3001\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72 (MHRA) \u548c\u52a0\u62ff\u5927\u536b\u751f\u90e8\u5ba3\u5e03\u8054\u5408\u4e3e\u529e\u7814\u8ba8\u4f1a\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e743\u670810\u65e5<\/strong>\uff0c \u8fd9 <strong>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA)<\/strong>, \u4e0e\u2026\u2026\u5408\u4f5c <strong>\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u5c40\uff08MHRA\uff09<\/strong> \u548c <strong>\u52a0\u62ff\u5927\u536b\u751f\u90e8<\/strong>, \u5e76\u53d1\u51fa\u8054\u5408\u63d0\u9192 <strong>\u6df7\u5408\u7814\u8ba8\u4f1a<\/strong> \u4e13\u6ce8\u4e8e <strong>\u826f\u597d\u4e34\u5e8a\u5b9e\u8df5\uff08GCP\uff09<\/strong>, <strong>\u751f\u7269\u7b49\u6548\u6027\uff08BE\uff09<\/strong>\uff0c \u548c <strong>\u826f\u597d\u836f\u7269\u8b66\u6212\u89c4\u8303\uff08GVP\uff09<\/strong>. \u5df2\u5b89\u6392 <strong>2026\u5e746\u67082\u65e5\u81f34\u65e5<\/strong>, \u672c\u6b21\u6d3b\u52a8\u5c06\u8ba8\u8bba <strong>\u4e0d\u65ad\u53d8\u5316\u7684\u76d1\u7ba1\u9884\u671f<\/strong> \u4ee5\u53ca\u5b9e\u65bd <strong>ICH E6(R3)<\/strong> \u904d\u53ca\u5317\u7f8e\u548c\u82f1\u56fd\u3002.<\/p>\n<div class=\"row\"  id=\"row-1399028069\">\n\n\t<div id=\"col-1995744673\" 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-1312392525\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1312392525 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1810320260\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1810320260 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6b21\u7814\u8ba8\u4f1a\u5c06\u6c47\u805a\u76d1\u7ba1\u9886\u57df\u7684\u4e13\u5bb6\uff0c\u5171\u540c\u63a2\u8ba8\u76f8\u5173\u8bae\u9898\u3002 <strong>\u5f53\u524d\u548c\u65b0\u5174\u7684\u9700\u6c42<\/strong> \u4e3a\u4e86 <strong>\u4e34\u5e8a\u8bd5\u9a8c<\/strong>, <strong>\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76<\/strong>\uff0c \u548c <strong>\u836f\u7269\u8b66\u6212\u5b9e\u8df5<\/strong>. \u4e2d\u5fc3\u4e3b\u9898\u5c06\u662f\u5b9e\u65bd <strong>ICH E6(R3)<\/strong>, \u4fee\u8ba2\u540e\u7684\u6307\u5357\u5f3a\u8c03\u4e86\u4ee5\u4e0b\u51e0\u70b9\uff1a <strong>\u4ee5\u8d28\u91cf\u4e3a\u4e2d\u5fc3\u4e14\u98ce\u9669\u9002\u5ea6\u7684\u65b9\u6cd5<\/strong> \u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u3002.<\/p>\n<p>\u4f1a\u8bae\u5c06\u63a2\u8ba8 <strong>\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u539f\u5219<\/strong> \u5728\u4e34\u5e8a\u7814\u7a76\u548c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u4e2d\uff0c\u91cd\u70b9\u4ecb\u7ecd\u5982\u4f55\u5c06\u8fd9\u4e9b\u65b9\u6cd5\u6574\u5408\u5230\u8bd5\u9a8c\u8ba1\u5212\u548c\u6267\u884c\u4e2d\u3002\u6b64\u5916\uff0c\u8fd8\u66f4\u65b0\u4e86\u4ee5\u4e0b\u5185\u5bb9\uff1a <strong>GVP \u8981\u6c42<\/strong> \u5c06\u4e3a\u8d1f\u8d23\u4ee5\u4e0b\u65b9\u9762\u7684\u5229\u76ca\u76f8\u5173\u8005\u63d0\u4f9b\u6307\u5bfc\uff1a <strong>\u60a3\u8005\u5b89\u5168\u76d1\u6d4b<\/strong>.<\/p>\n<p>\u6765\u81ea\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u3001\u82f1\u56fd\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u76d1\u7ba1\u7f72\uff08MHRA\uff09\u4ee5\u53ca\u52a0\u62ff\u5927\u536b\u751f\u90e8\u7684\u76d1\u7ba1\u673a\u6784\u4e5f\u5c06\u5206\u4eab\u76f8\u5173\u89c1\u89e3\u3002 <strong>\u6307\u5bfc\u5236\u5b9a<\/strong>, <strong>\u68c0\u67e5\u51c6\u5907<\/strong>\uff0c \u548c <strong>\u56fd\u9645\u534f\u8c03\u52aa\u529b<\/strong>, \u63d0\u4f9b\u8de8\u533a\u57df\u7684\u5408\u89c4\u671f\u671b\u89c6\u89d2\u3002.<\/p>\n<p>\u672c\u6b21\u6d3b\u52a8\u73b0\u5df2\u5f00\u653e\u6ce8\u518c\uff0c\u5e76\u5c06\u4ee5\u2026\u2026\u7684\u5f62\u5f0f\u4e3e\u884c\u3002 <strong>\u6df7\u5408\u683c\u5f0f<\/strong>, \u66f4\u591a\u8be6\u60c5\u8bf7\u89c1FDA\u7f51\u7ad9\u3002 <strong>\u5c0f\u578b\u4f01\u4e1a\u548c\u884c\u4e1a\u63f4\u52a9<\/strong> \u9891\u9053\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1995744673 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1894087005\" 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>\u6d3b\u52a8\u65e5\u671f<\/h2>\n\t<div id=\"gap-502001181\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-502001181 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7814\u8ba8\u4f1a\u5c06\u4e8e <strong>2026\u5e746\u67082\u65e5\u81f36\u67084\u65e5<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1894087005 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-753815716\" 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-55725739\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-55725739 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6b21\u7814\u8ba8\u4f1a\u63d0\u4f9b <strong>\u5173\u952e\u76d1\u7ba1\u6e05\u6670\u5ea6<\/strong> \u5173\u4e8e\u91c7\u7eb3 <strong>ICH E6(R3)<\/strong> \u53ca\u5176\u5bf9\u2026\u2026\u7684\u5f71\u54cd <strong>\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u3001\u5b89\u5168\u76d1\u6d4b\u548c\u5408\u89c4\u6846\u67b6<\/strong>. \u5b83\u652f\u6301 <strong>\u5168\u7403\u5bf9\u9f50<\/strong> \u8de8\u8d8a\u76d1\u7ba1\u673a\u6784\u5e76\u8fdb\u884c\u63a8\u5e7f <strong>\u9ad8\u6548\u3001\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5<\/strong> \u7528\u4e8e\u836f\u7269\u7814\u53d1\u548c\u4e0a\u5e02\u540e\u76d1\u6d4b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-753815716 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1959799607\" 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\u4f1a\u5f71\u54cd\u54ea\u4e9b\u4eba<\/h2>\n\t<div id=\"gap-2138751691\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2138751691 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u9002\u7528\u4e8e <strong>\u76d1\u7ba1\u4e8b\u52a1<\/strong>, <strong>\u8d28\u91cf\u4fdd\u8bc1<\/strong>, <strong>\u60a3\u8005\u5b89\u5168<\/strong>, <strong>\u6cd5\u5f8b\/\u5408\u89c4<\/strong>, <strong>\u7814\u53d1<\/strong>\uff0c \u548c <strong>\u5546\u4e1a\u56e2\u961f<\/strong> \u53c2\u4e0e <strong>\u4e34\u5e8a\u5f00\u53d1\u3001\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u548c\u836f\u7269\u8b66\u6212\u6d3b\u52a8<\/strong> \u6db5\u76d6\u5728\u5317\u7f8e\u548c\u82f1\u56fd\u8fd0\u8425\u7684\u5236\u836f\u516c\u53f8\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1959799607 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1208907994\" 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-1251255215\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1251255215 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7ec4\u7ec7\u5e94\u8be5 <strong>\u76d1\u6d4b\u7814\u8ba8\u4f1a\u4f1a\u8bae\u8bb0\u5f55<\/strong> \u6216\u8ba1\u5212 <strong>\u56de\u987e\u6d3b\u52a8\u540e\u6750\u6599<\/strong> \u8bc4\u4f30\u5982\u4f55 <strong>ICH E6(R3)\u5b9e\u65bd<\/strong> \u76d1\u7ba1\u8981\u6c42\u7684\u66f4\u65b0\u53ef\u80fd\u4f1a\u5f71\u54cd\u6b63\u5728\u8fdb\u884c\u6216\u672a\u6765\u7684\u4e34\u5e8a\u9879\u76ee\u3002\u56e2\u961f\u4e5f\u53ef\u80fd\u8003\u8651 <strong>\u53c2\u52a0\u6d3b\u52a8<\/strong> \u4ee5\u4fbf\u76f4\u63a5\u4e86\u89e3\u4e0d\u65ad\u53d8\u5316\u7684\u5408\u89c4\u548c\u68c0\u67e5\u91cd\u70b9\u3002.<\/p>\n<p>\u968f\u7740\u5168\u7403\u5bf9\u4e34\u5e8a\u7814\u7a76\u548c\u5b89\u5168\u76d1\u6d4b\u7684\u76d1\u7ba1\u8981\u6c42\u4e0d\u65ad\u53d8\u5316\uff0c\u53ca\u65f6\u4e86\u89e3\u7edf\u4e00\u7684\u6307\u5bfc\u65b9\u9488\u5bf9\u4e8e\u4fdd\u6301\u5408\u89c4\u6027\u548c\u8fd0\u8425\u51c6\u5907\u81f3\u5173\u91cd\u8981\u3002.<\/p>\n<p><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\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\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\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 160 \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\/\">\u9884\u8ba2\u6f14\u793a<\/a> \u73b0\u5728\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1208907994 > .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-1244547585\">\n\n\t<div id=\"col-1062256734\" 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-990647786\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-990647786 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>FDA-MHRA-\u52a0\u62ff\u5927\u536b\u751f\u90e8\u8054\u5408\u7814\u8ba8\u4f1a\u7684\u76ee\u7684\u662f\u4ec0\u4e48\uff1f<\/h4>\n\t<div id=\"gap-157533838\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-157533838 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u7814\u8ba8\u4f1a\u5c06\u63d0\u4f9b\u5173\u4e8e\u4ee5\u4e0b\u65b9\u9762\u7684\u6700\u65b0\u4fe1\u606f\uff1a <strong>\u76d1\u7ba1\u673a\u6784\u5bf9GCP\u3001\u751f\u7269\u7b49\u6548\u6027\u548c\u836f\u7269\u8b66\u6212\u7684\u671f\u671b<\/strong>, \u91cd\u70b9\u662f <strong>ICH E6(R3)\u5b9e\u65bd<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1062256734 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1630374064\" 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>\u7814\u8ba8\u4f1a\u4f55\u65f6\u4e3e\u884c\uff1f<\/h4>\n\t<div id=\"gap-2111232887\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2111232887 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5df2\u5b89\u6392\u597d <strong>2026\u5e746\u67082\u65e5\u81f34\u65e5<\/strong>, \u5e76\u5c06\u4e8e <strong>\u6df7\u5408\u683c\u5f0f<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1630374064 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1469733827\" 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>\u672c\u6b21\u6d3b\u52a8\u5c06\u6db5\u76d6\u54ea\u4e9b\u4e3b\u9898\uff1f<\/h4>\n\t<div id=\"gap-711173942\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-711173942 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u4f1a\u8bae\u5c06\u8ba8\u8bba <strong>\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1<\/strong>, <strong>\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76<\/strong>, <strong>GVP \u66f4\u65b0<\/strong>\uff0c \u548c <strong>\u56fd\u9645\u76d1\u7ba1\u534f\u8c03\u52aa\u529b<\/strong>.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1469733827 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-841725891\" 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>RegASK \u5982\u4f55\u652f\u6301\u56e2\u961f\u51c6\u5907 ICH E6(R3) \u548c\u4e0d\u65ad\u53d8\u5316\u7684 GCP \u8981\u6c42\uff1f<\/h4>\n\t<div id=\"gap-1454554135\" class=\"gap-element clearfix\" style=\"display:block; 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Scheduled for June 2\u20134, 2026, the event will address&#8230;<\/p>","protected":false},"author":32,"featured_media":9713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[530,35,33],"tags":[],"class_list":["post-9712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-north-america","category-pharma-biotech-latest-insights","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA MHRA and Health Canada Announce a Focus on GCP Practices<\/title>\n<meta name=\"description\" content=\"Learn about the upcoming symposium focused on GCP bioequivalence and pharmacovigilance hosted by the FDA, MHRA, and Health Canada.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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