{"id":9582,"date":"2026-03-03T21:42:52","date_gmt":"2026-03-03T13:42:52","guid":{"rendered":"https:\/\/regask.com\/?p=9582"},"modified":"2026-03-03T21:43:42","modified_gmt":"2026-03-03T13:43:42","slug":"%e9%a9%ac%e6%9d%a5%e8%a5%bf%e4%ba%9a%e5%9b%bd%e5%ae%b6%e8%8d%af%e5%93%81%e7%9b%91%e7%ae%a1%e6%9c%ba%e6%9e%84%ef%bc%88npra%ef%bc%89%e5%bc%ba%e5%88%b6%e8%a6%81%e6%b1%82%e4%b8%b4%e5%ba%8a%e8%af%95","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","title":{"rendered":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40\u5f3a\u5236\u8981\u6c42\u5408\u683c\u4eba\u5458\u7533\u62a5\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e742\u670823\u65e5,<\/strong> \u8fd9 <strong>\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40\uff08NPRA\uff09<\/strong> \u6839\u636e\u300a\u836f\u54c1\u548c\u5316\u5986\u54c1\u7ba1\u5236\u6761\u4f8b\u300b\u53d1\u5e03\u4e86\u4e00\u9879\u65b0\u6307\u4ee4\uff0c\u5f15\u5165\u4e86\u989d\u5916\u5185\u5bb9 <strong>\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08GMP\uff09<\/strong> \u5408\u89c4\u8981\u6c42 <strong>\u7814\u7a76\u6027\u836f\u54c1<\/strong> \u8be5\u6307\u4ee4\u5f71\u54cd\u9a6c\u6765\u897f\u4e9a\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002 <strong>\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u548c\u8d5e\u52a9\u5546<\/strong> \u7533\u8bf7<strong> \u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u53e3\u8bb8\u53ef\u8bc1\uff08CTIL\uff09 <\/strong>\u6216\u8005<strong> \u4e34\u5e8a\u8bd5\u9a8c\u8c41\u514d (CTX) <\/strong>\u5e76\u4e14\u662f<strong> \u7acb\u5373\u751f\u6548\u3002. <\/strong><\/p>\n<div class=\"row\"  id=\"row-1815960785\">\n\n\t<div id=\"col-1719327152\" 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-863139268\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-863139268 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-2051703942\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2051703942 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6839\u636e\u65b0\u6307\u4ee4\uff0c\u7533\u8bf7\u4eba\u5fc5\u987b\u63d0\u4ea4\u4e00\u4efd <strong>\u5408\u683c\u4eba\u5458\u58f0\u660e<\/strong> \u5f53\u7814\u7a76\u7528\u836f\u54c1\u5728\u4e0d\u9881\u53d1\u5b98\u65b9GMP\u8bc1\u4e66\u7684\u53f8\u6cd5\u7ba1\u8f96\u533a\u751f\u4ea7\u65f6\uff0c\u53ef\u4f5c\u4e3aGMP\u5408\u89c4\u6027\u7684\u6b63\u5f0f\u8bc1\u636e\u3002\u8fd9\u5305\u62ec\u4ece\u4ee5\u4e0b\u5730\u533a\u91c7\u8d2d\u7684\u4ea7\u54c1\uff1a <strong>\u4e2d\u56fd\u3001\u7f8e\u56fd\u3001\u4e1c\u76df\u56fd\u5bb6\u548c\u5176\u4ed6\u5730\u533a<\/strong> \u6ca1\u6709GMP\u8ba4\u8bc1\u6846\u67b6\u3002.<\/p>\n<p>\u8be5\u58f0\u660e\u5fc5\u987b\u786e\u8ba4\u751f\u4ea7\u6d3b\u52a8\u662f <strong>\u7b49\u540c\u4e8eICH\u6216PIC\/S GMP\u6807\u51c6\u3002.<\/strong> \u5b83\u8fd8\u5fc5\u987b\u5305\u62ec <strong>\u5ba1\u8ba1\u8be6\u60c5<\/strong> \u7531\u5408\u683c\u4eba\u5458\u8fdb\u884c\uff0c\u6216\u8005\uff0c\u5728\u4e0d\u8fdb\u884c\u5ba1\u8ba1\u7684\u60c5\u51b5\u4e0b\uff0c\u7531\u2026\u2026 <strong>\u4e66\u9762\u7406\u7531<\/strong> \u89e3\u91ca\u5176\u7406\u7531\u3002\u6839\u636e\u63d0\u4ea4\u7684\u58f0\u660e\uff0c, <strong>\u751f\u4ea7\u573a\u6240\u53ef\u80fd\u9700\u8981\u63a5\u53d7\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40 (NPRA) \u7684\u68c0\u67e5\u3002<\/strong> \u4f5c\u4e3a\u5ba1\u67e5\u8fc7\u7a0b\u7684\u4e00\u90e8\u5206\u3002.<\/p>\n<p>\u5168\u90e8 <strong>\u65b0\u7684 CTIL \u548c CTX \u5e94\u7528<\/strong> \u6d89\u53ca\u6765\u81ea\u53d7\u5f71\u54cd\u5730\u533a\u7684\u8bd5\u9a8c\u6027\u836f\u54c1\u5fc5\u987b\u9075\u5b88\u8fd9\u4e9b\u89c4\u5b9a\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1719327152 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1603840045\" 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-250054359\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-250054359 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u672c\u6307\u4ee4\u89c4\u5b9a <strong>\u76d1\u7ba1\u900f\u660e\u5ea6<\/strong> \u5bf9\u4e8e\u4ece\u672a\u83b7\u5f97GMP\u8ba4\u8bc1\u7684\u56fd\u5bb6\u91c7\u8d2d\u7814\u7a76\u7528\u836f\u54c1\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7533\u529e\u65b9\u800c\u8a00\uff0cNPRA\u901a\u8fc7\u300a\u5408\u683c\u4eba\u5458\u58f0\u660e\u300b\u6b63\u5f0f\u786e\u7acb\u66ff\u4ee3\u6027GMP\u8bc1\u636e\uff0c\u4ece\u800c\u63d0\u4f9b\u652f\u6301\u3002 <strong>\u76d1\u7ba1\u65b9\u9762\u4e0e\u56fd\u9645\u6807\u51c6\u4fdd\u6301\u4e00\u81f4,<\/strong> \u589e\u5f3a <strong>\u76d1\u7ba1\u6548\u7387,<\/strong> \u5728\u786e\u4fdd\u5408\u89c4\u6027\u7684\u540c\u65f6\uff0c\u6700\u5927\u9650\u5ea6\u5730\u51cf\u5c11\u4e34\u5e8a\u8bd5\u9a8c\u5ba1\u6279\u7684\u7a0b\u5e8f\u969c\u788d\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1603840045 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1066808290\" 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-1388653525\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1388653525 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u6b21\u66f4\u65b0\u4e0e\u4ee5\u4e0b\u5185\u5bb9\u76f8\u5173\uff1a <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u4e34\u5e8a\u8fd0\u8425\u548c\u5408\u89c4\u56e2\u961f,<\/strong> \u4e5f <strong>\u5236\u9020\u5546\u3001\u8fdb\u53e3\u5546\u548c\u8d5e\u52a9\u5546<\/strong> \u53c2\u4e0e\u8fdb\u53e3\u6216\u751f\u4ea7\u7528\u4e8e\u9a6c\u6765\u897f\u4e9a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7814\u7a76\u6027\u836f\u54c1\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1066808290 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1233538047\" 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-1090689029\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1090689029 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5229\u76ca\u76f8\u5173\u8005\u5e94\u5ba1\u67e5\u5f53\u524d\u548c\u5373\u5c06\u63a8\u51fa\u7684\u9879\u76ee\u3002 <strong>CTIL \u548c CTX<\/strong> <strong>\u5e94\u7528\u7a0b\u5e8f<\/strong> \u8bc6\u522b\u6765\u81ea\u53d7\u5f71\u54cd\u5730\u533a\u7684\u8bd5\u9a8c\u6027\u836f\u54c1\u3002\u76d1\u7ba1\u4e8b\u52a1\u56e2\u961f\u5e94\u4e0e\u2026\u2026\u534f\u8c03 <strong>\u8d28\u91cf\u4fdd\u8bc1<\/strong> \u51c6\u5907\u6240\u9700\u6750\u6599 <strong>\u5408\u683c\u4eba\u5458\u58f0\u660e,<\/strong> \u786e\u4fddGMP\u7b49\u6548\u6027\u58f0\u660e\u3001\u5ba1\u6838\u6587\u4ef6\u6216\u4e66\u9762\u8bf4\u660e\u5b8c\u6574\u4e14\u7b26\u5408NPRA\u7684\u8981\u6c42\u3002\u540c\u65f6\uff0c\u5e94\u5ba1\u67e5\u5e76\u66f4\u65b0\u5185\u90e8\u4f9b\u5e94\u5546\u8d44\u8d28\u8ba4\u8bc1\u548c\u6587\u4ef6\u6d41\u7a0b\uff0c\u4ee5\u652f\u6301\u6301\u7eed\u5408\u89c4\u3002.<\/p>\n<p>\u968f\u7740\u4e0d\u540c\u53f8\u6cd5\u7ba1\u8f96\u533a\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4ea7\u54c1\u7684\u76d1\u7ba1\u8981\u6c42\u4e0d\u65ad\u53d8\u5316\uff0c, <a href=\"http:\/\/regask.com\/zh\/\"><strong>RegASK<\/strong><\/a> \u652f\u6301\u56e2\u961f\u9075\u5b88\u5f53\u5730GMP\u89c4\u8303\u548c\u7533\u62a5\u8981\u6c42\u3002. <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\u5b83\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7ec4\u7ec7\uff08\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\uff09\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002. <strong>\u901a\u8fc7\u5c06\u5148\u8fdb\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u4e0e\u4e13\u5bb6\u56e2\u961f\u76f8\u7ed3\u5408\uff0c, <a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> \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><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1233538047 > .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-180218953\">\n\n\t<div id=\"col-1110171639\" 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-1917648830\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1917648830 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><span class=\"TextRun MacChromeBold SCXW229157140 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW229157140 BCX0\">\u6839\u636eNPRA\u6307\u4ee4\uff0c\u4ec0\u4e48\u662f\u5408\u683c\u4eba\u5458\u58f0\u660e\uff1f<\/span><\/span><span class=\"EOP SCXW229157140 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-128190657\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-128190657 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5bf9\u4e8e\u5728\u4e0d\u9881\u53d1\u5b98\u65b9 GMP \u8bc1\u4e66\u7684\u53f8\u6cd5\u7ba1\u8f96\u533a\u751f\u4ea7\u7684\u7814\u7a76\u7528\u836f\u54c1\uff0c\u8fd9\u662f\u4e00\u4efd\u5f3a\u5236\u6027\u6587\u4ef6\uff0c\u7528\u4e8e\u786e\u8ba4\u5176\u7b26\u5408 GMP \u6807\u51c6\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1110171639 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1219447566\" 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>\u54ea\u4e9b\u5e94\u7528\u7a0b\u5e8f\u4f1a\u53d7\u5230\u6b64\u8981\u6c42\u7684\u5f71\u54cd\uff1f<\/h4>\n\t<div id=\"gap-595580176\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-595580176 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u5168\u65b0 <strong>CTIL \u548c CTX \u5e94\u7528<\/strong> \u6d89\u53ca\u6765\u81ea\u53d7\u5f71\u54cd\u5730\u533a\u7684\u8bd5\u9a8c\u6027\u836f\u54c1\u5fc5\u987b\u9075\u5b88\u76f8\u5173\u89c4\u5b9a\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1219447566 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-820053434\" 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>\u58f0\u660e\u4e2d\u5fc5\u987b\u5f15\u7528\u54ea\u4e9bGMP\u6807\u51c6\uff1f<\/h4>\n\t<div id=\"gap-1479316188\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1479316188 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u58f0\u660e\u5fc5\u987b\u786e\u8ba4\u5176\u4e0eGMP\u7b49\u6548\u3002<strong> ICH \u6216 PIC\/S \u6807\u51c6\uff0c,<\/strong> \u9700\u63d0\u4f9b\u5ba1\u8ba1\u7ec6\u8282\u6216\u4e66\u9762\u8bc1\u660e\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-820053434 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1323489\" 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\u5e2e\u52a9\u7ec4\u7ec7\u9075\u5b88 NPRA \u6307\u4ee4\uff1f<\/h4>\n\t<div id=\"gap-2032498840\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2032498840 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong><a href=\"http:\/\/regask.com\/zh\/\">RegASK<\/a><\/strong> \u5e2e\u52a9\u76d1\u7ba1\u548c\u8d28\u91cf\u56e2\u961f\u8ddf\u8e2a NPRA \u66f4\u65b0\uff0c\u8bc4\u4f30\u5176\u5bf9\u6b63\u5728\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u9002\u7528\u6027\uff0c\u5e76\u7b80\u5316\u652f\u6301 GMP \u5408\u89c4\u58f0\u660e\u6240\u9700\u7684\u6587\u6863\u5de5\u4f5c\u6d41\u7a0b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1323489 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>On 23 February 2026, the National Pharmaceutical Regulatory Agency (NPRA) published a new directive under the Drugs and Cosmetics Control Regulations introducing additional Good Manufacturing Practices (GMP) compliance requirements for investigational medicinal products used in clinical trials in Malaysia. The directive affects manufacturers, importers, and sponsors applying for Clinical Trial Import Licenses (CTIL) or Clinical&#8230;<\/p>","protected":false},"author":41,"featured_media":9584,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33,39,584],"tags":[],"class_list":["post-9582","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-medical-devices-insights","category-malaysia-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>NPRA Malaysia Mandates Declaration of Competent Personnel<\/title>\n<meta name=\"description\" content=\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/zh\/\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08npra\uff09\u5f3a\u5236\u8981\u6c42\u4e34\u5e8a\u8bd5\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NPRA Malaysia Mandates Declaration of Competent Personnel for GMP Compliance in Clinical Trial Products\" \/>\n<meta property=\"og:description\" content=\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/zh\/\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08npra\uff09\u5f3a\u5236\u8981\u6c42\u4e34\u5e8a\u8bd5\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-03T13:42:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-03-03T13:43:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Shaffa Renaningtyas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u4f5c\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Shaffa Renaningtyas\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 \u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"},\"author\":{\"name\":\"Shaffa Renaningtyas\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\"},\"headline\":\"NPRA Malaysia Mandates Declaration of Competent Personn&hellip;\",\"datePublished\":\"2026-03-03T13:42:52+00:00\",\"dateModified\":\"2026-03-03T13:43:42+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"},\"wordCount\":737,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"articleSection\":[\"Regulatory News\",\"Medical Devices\",\"Malaysia\"],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\",\"name\":\"NPRA Malaysia Mandates Declaration of Competent Personnel\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"datePublished\":\"2026-03-03T13:42:52+00:00\",\"dateModified\":\"2026-03-03T13:43:42+00:00\",\"description\":\"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.\",\"inLanguage\":\"zh-Hans\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png\",\"width\":800,\"height\":600,\"caption\":\"Npra Malaysia Mandates Declaration Competent Personnel Gmp Compliance Clinical Trial Products\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh-Hans\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh-Hans\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/b0e1938ef6f244f9f052a21f21cba1b6\",\"name\":\"Shaffa Renaningtyas\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u8b66\u5bdf\u76d1\u7ba1\u5c40\u5f3a\u5236\u8981\u6c42\u5408\u683c\u4eba\u5458\u7533\u62a5","description":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40 (NPRA) \u8981\u6c42\u4e34\u5e8a\u8bd5\u9a8c\u4ea7\u54c1\u5fc5\u987b\u63d0\u4ea4\u5408\u683c\u4eba\u5458\u58f0\u660e\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (GMP)\u3002\u7acb\u5373\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\u3002.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/zh\/\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08npra\uff09\u5f3a\u5236\u8981\u6c42\u4e34\u5e8a\u8bd5\/","og_locale":"zh_CN","og_type":"article","og_title":"NPRA Malaysia Mandates Declaration of Competent Personnel for GMP Compliance in Clinical Trial Products","og_description":"NPRA Malaysia mandates a Declaration of Competent Personnel for GMP compliance in clinical trial products. Learn more now.","og_url":"https:\/\/regask.com\/zh\/\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u673a\u6784\uff08npra\uff09\u5f3a\u5236\u8981\u6c42\u4e34\u5e8a\u8bd5\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2026-03-03T13:42:52+00:00","article_modified_time":"2026-03-03T13:43:42+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","type":"image\/png"}],"author":"Shaffa Renaningtyas","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"\u4f5c\u8005":"Shaffa Renaningtyas","\u9884\u8ba1\u9605\u8bfb\u65f6\u95f4":"4 \u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#article","isPartOf":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"},"author":{"name":"Shaffa Renaningtyas","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6"},"headline":"NPRA Malaysia Mandates Declaration of Competent Personn&hellip;","datePublished":"2026-03-03T13:42:52+00:00","dateModified":"2026-03-03T13:43:42+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"},"wordCount":737,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","articleSection":["Regulatory News","Medical Devices","Malaysia"],"inLanguage":"zh-Hans"},{"@type":"WebPage","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","url":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/","name":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u8b66\u5bdf\u76d1\u7ba1\u5c40\u5f3a\u5236\u8981\u6c42\u5408\u683c\u4eba\u5458\u7533\u62a5","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","datePublished":"2026-03-03T13:42:52+00:00","dateModified":"2026-03-03T13:43:42+00:00","description":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40 (NPRA) \u8981\u6c42\u4e34\u5e8a\u8bd5\u9a8c\u4ea7\u54c1\u5fc5\u987b\u63d0\u4ea4\u5408\u683c\u4eba\u5458\u58f0\u660e\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (GMP)\u3002\u7acb\u5373\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\u3002.","inLanguage":"zh-Hans","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/"]}]},{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/npra-malaysia-mandates-declaration-of-competent-personnel-for-gmp-compliance-in-clinical-trial-products\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2026\/03\/npra-malaysia-mandates-declaration-competent-personnel-gmp-compliance-clinical-trial-products.png","width":800,"height":600,"caption":"Npra Malaysia Mandates Declaration Competent Personnel Gmp Compliance Clinical Trial Products"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"\u52a9\u529b\u66f4\u660e\u667a\u7684\u76d1\u7ba1\u51b3\u7b56","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh-Hans"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"zh-Hans","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/b0e1938ef6f244f9f052a21f21cba1b6","name":"\u6c99\u6cd5\u00b7\u96f7\u7eb3\u5b81\u8482\u4e9a\u65af"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/9582","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/users\/41"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/comments?post=9582"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/posts\/9582\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media\/9584"}],"wp:attachment":[{"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/media?parent=9582"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/categories?post=9582"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/zh\/wp-json\/wp\/v2\/tags?post=9582"}],"curies":[{"name":"\u53ef\u6e7f\u6027\u7c89\u5242","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}