{"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":"directrices-de-terapia-genica-celular-en-malasia","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/malaysia-cell-gene-therapy-guidelines\/","title":{"rendered":"La NPRA de Malasia inicia una consulta p\u00fablica sobre la ac..."},"content":{"rendered":"<p>El 7 de octubre de 2024, el <a href=\"https:\/\/regask.com\/es\/npra-malasia-publico-un-documento-de-orientacion-y-directrices-sobre-biosimilares\/\">Agencia Nacional de Regulaci\u00f3n Farmac\u00e9utica (NPRA)<\/a> de Malasia anunci\u00f3 el lanzamiento de una consulta p\u00fablica para la segunda edici\u00f3n de la <strong>\u201cDocumento de orientaci\u00f3n y directrices para el registro de productos de terapia celular y g\u00e9nica (CGTP) en Malasia\u201d.<\/strong> La consulta se desarrollar\u00e1 desde<strong> 7 de octubre de 2024 al 7 de noviembre de 2024, <\/strong>Los CGTP, clasificados como productos biol\u00f3gicos seg\u00fan la Ley de Venta de Medicamentos de 1952 y el Reglamento de Control de Medicamentos y Cosm\u00e9ticos de 1984 de Malasia, desempe\u00f1an un papel fundamental en los avances m\u00e9dicos y requieren una supervisi\u00f3n estricta para garantizar su seguridad, eficacia y calidad.<\/p>\n<p>Las principales enmiendas propuestas incluyen:<\/p>\n<ul>\n<li><strong>Perfeccionamiento de la reglamentaci\u00f3n<\/strong>:Ajustes para los CGTP de clase I, incluidas actualizaciones a los marcos regulatorios y de seguridad.<\/li>\n<li><strong>Revisiones de los requisitos de BPM y BPL<\/strong>:Garantizar est\u00e1ndares actualizados para las Buenas Pr\u00e1cticas de Manufactura (BPM) y aclarar los requisitos de las Buenas Pr\u00e1cticas de Laboratorio (BPL).<\/li>\n<li><strong>Actualizaciones de las directrices<\/strong>:Eliminaci\u00f3n de las directrices obsoletas para las buenas pr\u00e1cticas en materia de tejidos (BPT).<\/li>\n<\/ul>\n<p>La consulta involucra a una amplia gama de partes interesadas, incluidos fabricantes de CGTP, compa\u00f1\u00edas farmac\u00e9uticas, asociaciones, profesionales, investigadores y acad\u00e9micos. El documento se alinea con las pautas nacionales e internacionales, como las de la <strong>Organizaci\u00f3n Mundial de la Salud (OMS)<\/strong>, <strong>Conferencia Internacional sobre Armonizaci\u00f3n (ICH)<\/strong>, <strong>FDA de EE.UU.<\/strong>, y <strong>Agencia Europea de Medicamentos (EMA)<\/strong>.<\/p>\n<p>Esta actualizaci\u00f3n refleja el compromiso de Malasia de mantener altos est\u00e1ndares en el campo en constante evoluci\u00f3n de la terapia celular y g\u00e9nica. Para quienes participan, esta consulta representa una oportunidad vital de contribuir al futuro de la regulaci\u00f3n de la terapia celular y g\u00e9nica en el pa\u00eds.<\/p>\n<p>Para obtener m\u00e1s informaci\u00f3n, consulte a 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 v27.3 (Yoast SEO v27.5) - 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. 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