{"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":"%e3%83%9e%e3%83%ac%e3%83%bc%e3%82%b7%e3%82%a2%e7%b4%b0%e8%83%9e%e9%81%ba%e4%bc%9d%e5%ad%90%e6%b2%bb%e7%99%82%e3%82%ac%e3%82%a4%e3%83%89%e3%83%a9%e3%82%a4%e3%83%b3","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/malaysia-cell-gene-therapy-guidelines\/","title":{"rendered":"\u30de\u30ec\u30fc\u30b7\u30a2\u306e NPRA \u304c\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306b\u95a2\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u958b\u59cb"},"content":{"rendered":"<p>2024\u5e7410\u67087\u65e5\u3001 <a 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\u898f\u5236\u304a\u3088\u3073\u5b89\u5168\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u66f4\u65b0\u3092\u542b\u3080\u3001\u30af\u30e9\u30b9 I CGTP \u306e\u8abf\u6574\u3002<\/li>\n<li><strong>GMP\u304a\u3088\u3073GLP\u8981\u4ef6\u306e\u6539\u8a02<\/strong>: \u9069\u6b63\u88fd\u9020\u57fa\u6e96 (GMP) \u306e\u6700\u65b0\u57fa\u6e96\u3092\u78ba\u4fdd\u3057\u3001\u9069\u6b63\u5b9f\u9a13\u5ba4\u57fa\u6e96 (GLP) \u8981\u4ef6\u3092\u660e\u78ba\u5316\u3057\u307e\u3059\u3002<\/li>\n<li><strong>\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u66f4\u65b0<\/strong>: \u53e4\u304f\u306a\u3063\u305f\u9069\u6b63\u7d44\u7e54\u7ba1\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3 (GTP) \u306e\u524a\u9664\u3002<\/li>\n<\/ul>\n<p>\u3053\u306e\u5354\u8b70\u306b\u306f\u3001CGTP\u88fd\u9020\u696d\u8005\u3001\u88fd\u85ac\u4f1a\u793e\u3001\u5354\u4f1a\u3001\u5b9f\u52d9\u5bb6\u3001\u7814\u7a76\u8005\u3001\u5b66\u8005\u306a\u3069\u3001\u5e45\u5e83\u3044\u95a2\u4fc2\u8005\u304c\u53c2\u52a0\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u6587\u66f8\u306f\u3001 <strong>\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff08WHO\uff09<\/strong>, <strong>\u56fd\u969b\u8abf\u548c\u4f1a\u8b70 (ICH)<\/strong>, <strong>\u7c73\u56fdFDA<\/strong>\u3001 \u305d\u3057\u3066 <strong>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09<\/strong>.<\/p>\n<p>\u3053\u306e\u66f4\u65b0\u306f\u3001\u9032\u5316\u3059\u308b\u7d30\u80de\u304a\u3088\u3073\u907a\u4f1d\u5b50\u6cbb\u7642\u306e\u5206\u91ce\u3067\u9ad8\u3044\u57fa\u6e96\u3092\u7dad\u6301\u3059\u308b\u3068\u3044\u3046\u30de\u30ec\u30fc\u30b7\u30a2\u306e\u53d6\u308a\u7d44\u307f\u3092\u53cd\u6620\u3057\u3066\u3044\u307e\u3059\u3002\u95a2\u4fc2\u8005\u306b\u3068\u3063\u3066\u3001\u3053\u306e\u5354\u8b70\u306f\u3001\u540c\u56fd\u306b\u304a\u3051\u308b CGTP \u898f\u5236\u306e\u5c06\u6765\u306b\u8ca2\u732e\u3059\u308b\u91cd\u8981\u306a\u6a5f\u4f1a\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n<p>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001RegAsk\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/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 final chance to provide input before the guidelines are finalized. CGTPs, classified as biological products under Malaysia\u2019s Sale of Drugs Act 1952 and Control of Drugs and Cosmetics Regulations 1984, play a critical role in medical advancements, requiring stringent oversight to ensure their safety, efficacy, and quality. Key proposed amendments include: Refinement of Regulations: Adjustments&#8230;<\/p>","protected":false},"author":43,"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 v28.4 (Yoast SEO v28.5) - 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. Stay informed and participate in the public consultation.\" \/>\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\/ja\/\u30de\u30ec\u30fc\u30b7\u30a2\u7d30\u80de\u907a\u4f1d\u5b50\u6cbb\u7642\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Malaysia&#039;s NPRA Begins Public Consultation on Updated Guidelines for Cell and Gene Therapy Products\" \/>\n<meta property=\"og:description\" content=\"Malaysia&#039;s NPRA is updating guidelines for cell and gene therapy products. 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