{"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-672833330\">\n\n\t<div id=\"col-1208343025\" 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-843844996\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-843844996 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u8be6\u60c5<\/h2>\n\t<div id=\"gap-1989498854\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1989498854 {\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-1208343025 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-98695312\" 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-1731089755\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1731089755 {\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-98695312 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-273618551\" 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-1404462565\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1404462565 {\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-273618551 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1668813090\" 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-858428403\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-858428403 {\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-1668813090 > .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-883874418\">\n\n\t<div id=\"col-1327624154\" 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-1793009890\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1793009890 {\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-1817223980\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1817223980 {\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-1327624154 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-561447966\" 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-913518541\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-913518541 {\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-561447966 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1911317365\" 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-1003402007\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1003402007 {\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-1911317365 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1379760370\" 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-990787601\" class=\"gap-element clearfix\" style=\"display:block; 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