{"id":7667,"date":"2024-10-28T15:27:18","date_gmt":"2024-10-28T07:27:18","guid":{"rendered":"https:\/\/regask.com\/?p=7667"},"modified":"2024-11-21T09:22:50","modified_gmt":"2024-11-21T01:22:50","slug":"%e9%a9%ac%e6%9d%a5%e8%a5%bf%e4%ba%9a%e7%bb%86%e8%83%9e%e5%9f%ba%e5%9b%a0%e6%b2%bb%e7%96%97%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/malaysia-cell-gene-therapy-guidelines\/","title":{"rendered":"\u9a6c\u6765\u897f\u4e9a\u56fd\u5bb6\u76d1\u7ba1\u5c40\u5f00\u59cb\u5c31\u66f4\u65b0\u2026\u5c55\u5f00\u516c\u4f17\u54a8\u8be2"},"content":{"rendered":"<p>2024 \u5e74 10 \u6708 7 \u65e5\uff0c <a href=\"https:\/\/regask.com\/zh\/npra-%e9%a9%ac%e6%9d%a5%e8%a5%bf%e4%ba%9a%e5%8f%91%e5%b8%83%e7%94%9f%e7%89%a9%e4%bb%bf%e5%88%b6%e8%8d%af%e6%8c%87%e5%af%bc%e6%96%87%e4%bb%b6%e5%92%8c%e6%8c%87%e5%8d%97\/\">\u56fd\u5bb6\u836f\u54c1\u76d1\u7ba1\u5c40\uff08NPRA\uff09<\/a> \u9a6c\u6765\u897f\u4e9a\u5ba3\u5e03\u542f\u52a8\u7b2c\u4e8c\u7248 <strong>\u201c\u9a6c\u6765\u897f\u4e9a\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\uff08CGTP\uff09\u6ce8\u518c\u6307\u5bfc\u6587\u4ef6\u548c\u6307\u5357\u3002\u201d<\/strong> \u78cb\u5546\u5c06\u4e8e<strong> 2024 \u5e74 10 \u6708 7 \u65e5\u81f3 2024 \u5e74 11 \u6708 7 \u65e5 <\/strong>\u4e3a\u5229\u76ca\u76f8\u5173\u8005\u63d0\u4f9b\u5728\u6307\u5357\u6700\u7ec8\u786e\u5b9a\u4e4b\u524d\u63d0\u4f9b\u610f\u89c1\u7684\u6700\u540e\u673a\u4f1a\u3002CGTP \u6839\u636e\u9a6c\u6765\u897f\u4e9a 1952 \u5e74\u300a\u836f\u54c1\u9500\u552e\u6cd5\u300b\u548c 1984 \u5e74\u300a\u836f\u54c1\u548c\u5316\u5986\u54c1\u7ba1\u5236\u6761\u4f8b\u300b\u88ab\u5f52\u7c7b\u4e3a\u751f\u7269\u5236\u54c1\uff0c\u5728\u533b\u5b66\u8fdb\u6b65\u4e2d\u53d1\u6325\u7740\u5173\u952e\u4f5c\u7528\uff0c\u9700\u8981\u4e25\u683c\u76d1\u7763\u4ee5\u786e\u4fdd\u5176\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u548c\u8d28\u91cf\u3002<\/p>\n<p>\u62df\u8bae\u7684\u4e3b\u8981\u4fee\u6b63\u6848\u5305\u62ec\uff1a<\/p>\n<ul>\n<li><strong>\u5b8c\u5584\u89c4\u7ae0\u5236\u5ea6<\/strong>\uff1a\u5bf9 I \u7c7b CGTP \u7684\u8c03\u6574\uff0c\u5305\u62ec\u5bf9\u76d1\u7ba1\u548c\u5b89\u5168\u6846\u67b6\u7684\u66f4\u65b0\u3002<\/li>\n<li><strong>GMP \u548c GLP \u8981\u6c42\u7684\u4fee\u8ba2<\/strong>\uff1a\u786e\u4fdd\u66f4\u65b0\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08GMP\uff09\u7684\u6807\u51c6\u5e76\u660e\u786e\u826f\u597d\u5b9e\u9a8c\u5ba4\u89c4\u8303\uff08GLP\uff09\u7684\u8981\u6c42\u3002<\/li>\n<li><strong>\u6307\u5357\u66f4\u65b0<\/strong>\uff1a\u5220\u9664\u8fc7\u65f6\u7684\u826f\u597d\u7ec4\u7ec7\u89c4\u8303\uff08GTP\uff09\u6307\u5357\u3002<\/li>\n<\/ul>\n<p>\u6b64\u6b21\u54a8\u8be2\u6d89\u53ca\u5e7f\u6cdb\u7684\u5229\u76ca\u76f8\u5173\u8005\uff0c\u5305\u62ec CGTP \u5236\u9020\u5546\u3001\u5236\u836f\u516c\u53f8\u3001\u534f\u4f1a\u3001\u4ece\u4e1a\u8005\u3001\u7814\u7a76\u4eba\u5458\u548c\u5b66\u8005\u3002\u8be5\u6587\u4ef6\u7b26\u5408\u56fd\u5bb6\u548c\u56fd\u9645\u51c6\u5219\uff0c\u4f8b\u5982 <strong>\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09<\/strong>, <strong>\u56fd\u9645\u534f\u8c03\u4f1a\u8bae\uff08ICH\uff09<\/strong>, <strong>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40<\/strong>\uff0c \u548c <strong>\u6b27\u6d32\u836f\u54c1\u7ba1\u7406\u5c40\uff08EMA\uff09<\/strong>.<\/p>\n<p>\u6b64\u6b21\u66f4\u65b0\u53cd\u6620\u4e86\u9a6c\u6765\u897f\u4e9a\u81f4\u529b\u4e8e\u5728\u4e0d\u65ad\u53d1\u5c55\u7684\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u9886\u57df\u4fdd\u6301\u9ad8\u6807\u51c6\u7684\u627f\u8bfa\u3002\u5bf9\u4e8e\u53c2\u4e0e\u8005\u6765\u8bf4\uff0c\u6b64\u6b21\u54a8\u8be2\u4e3a\u8be5\u56fd\u672a\u6765\u7684 CGTP \u76d1\u7ba1\u505a\u51fa\u4e86\u91cd\u8981\u8d21\u732e\u3002<\/p>\n<p>\u5982\u9700\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u54a8\u8be2 RegAsk<\/p>\n<hr \/>","protected":false},"excerpt":{"rendered":"<p>On October 7, 2024, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia announced the launch of a public consultation for the 2nd edition of the &#8220;Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia.&#8221; The consultation will run from October 7, 2024, to November 7, 2024, offering stakeholders a&#8230;<\/p>","protected":false},"author":30,"featured_media":7759,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[507],"class_list":["post-7667","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-gene-therapy-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>Malaysia Cell &amp; Gene Therapy Guidelines Updated | RegASK<\/title>\n<meta name=\"description\" content=\"Malaysia&#039;s NPRA is updating guidelines for cell and gene therapy products. 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