{"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":"lignes-directrices-sur-la-therapie-genique-cellulaire-en-malaisie","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/malaysia-cell-gene-therapy-guidelines\/","title":{"rendered":"La NPRA de Malaisie lance une consultation publique sur la mise \u00e0 jour\u2026"},"content":{"rendered":"<p>Le 7 octobre 2024, le <a href=\"https:\/\/regask.com\/fr\/npra-malaysia-published-biosimilar-guidance-document-and-guidelines\/\">Agence nationale de r\u00e9glementation pharmaceutique (NPRA)<\/a> de Malaisie a annonc\u00e9 le lancement d&#039;une consultation publique pour la 2e \u00e9dition du <strong>\u00ab Document d\u2019orientation et lignes directrices pour l\u2019enregistrement des produits de th\u00e9rapie cellulaire et g\u00e9nique (CGTP) en Malaisie. \u00bb<\/strong> La consultation se d\u00e9roulera du<strong> Du 7 octobre 2024 au 7 novembre 2024, <\/strong>offrant aux parties prenantes une derni\u00e8re chance de donner leur avis avant que les lignes directrices ne soient finalis\u00e9es. Les CGTP, class\u00e9s comme produits biologiques en vertu de la loi malaisienne sur la vente de m\u00e9dicaments de 1952 et du r\u00e8glement sur le contr\u00f4le des m\u00e9dicaments et des cosm\u00e9tiques de 1984, jouent un r\u00f4le essentiel dans les avanc\u00e9es m\u00e9dicales, n\u00e9cessitant une surveillance rigoureuse pour garantir leur s\u00e9curit\u00e9, leur efficacit\u00e9 et leur qualit\u00e9.<\/p>\n<p>Les principaux amendements propos\u00e9s comprennent :<\/p>\n<ul>\n<li><strong>Affinement des r\u00e9glementations<\/strong>:Ajustements pour les CGTP de classe I, y compris les mises \u00e0 jour des cadres r\u00e9glementaires et de s\u00e9curit\u00e9.<\/li>\n<li><strong>R\u00e9visions des exigences GMP et GLP<\/strong>:Assurer la mise \u00e0 jour des normes de bonnes pratiques de fabrication (BPF) et la clarification des exigences de bonnes pratiques de laboratoire (BPL).<\/li>\n<li><strong>Mises \u00e0 jour des lignes directrices<\/strong>:Suppression des lignes directrices obsol\u00e8tes pour les bonnes pratiques en mati\u00e8re de tissus (GTP).<\/li>\n<\/ul>\n<p>La consultation implique un large \u00e9ventail de parties prenantes, notamment des fabricants de CGTP, des soci\u00e9t\u00e9s pharmaceutiques, des associations, des praticiens, des chercheurs et des universitaires. Le document s&#039;aligne sur les directives nationales et internationales, telles que celles de l&#039; <strong>Organisation mondiale de la sant\u00e9 (OMS)<\/strong>, <strong>Conf\u00e9rence internationale sur l&#039;harmonisation (ICH)<\/strong>, <strong>FDA des \u00c9tats-Unis<\/strong>, et <strong>Agence europ\u00e9enne des m\u00e9dicaments (EMA)<\/strong>.<\/p>\n<p>Cette mise \u00e0 jour refl\u00e8te l&#039;engagement de la Malaisie \u00e0 maintenir des normes \u00e9lev\u00e9es dans le domaine en pleine \u00e9volution de la th\u00e9rapie cellulaire et g\u00e9nique. Pour les personnes concern\u00e9es, cette consultation repr\u00e9sente une occasion essentielle de contribuer \u00e0 l&#039;avenir de la r\u00e9glementation du CGTP dans le pays.<\/p>\n<p>Pour plus d&#039;informations, demandez \u00e0 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":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 v27.8 (Yoast SEO v27.9) - 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\/fr\/lignes-directrices-sur-la-therapie-genique-cellulaire-en-malaisie\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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. Stay informed and participate in the public consultation.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/lignes-directrices-sur-la-therapie-genique-cellulaire-en-malaisie\/\" \/>\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=\"2024-10-28T07:27:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T01:22:50+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/malaysia-npra-begins-public-consultation-updated-guidelines-cell-gene-therapy-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=\"Reva Ananda\" \/>\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=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"Malaysia&#8217;s NPRA Begins Public Consultation on Upd&hellip;\",\"datePublished\":\"2024-10-28T07:27:18+00:00\",\"dateModified\":\"2024-11-21T01:22:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/\"},\"wordCount\":255,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/malaysia-npra-begins-public-consultation-updated-guidelines-cell-gene-therapy-products.png\",\"keywords\":[\"Gene Therapy Regulations\"],\"articleSection\":[\"Pharma and Biotech\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/\",\"name\":\"Malaysia Cell & Gene Therapy Guidelines Updated | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/malaysia-cell-gene-therapy-guidelines\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/malaysia-npra-begins-public-consultation-updated-guidelines-cell-gene-therapy-products.png\",\"datePublished\":\"2024-10-28T07:27:18+00:00\",\"dateModified\":\"2024-11-21T01:22:50+00:00\",\"description\":\"Malaysia's NPRA is updating guidelines for cell and gene therapy products. 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