{"id":7963,"date":"2025-01-28T18:17:25","date_gmt":"2025-01-28T10:17:25","guid":{"rendered":"https:\/\/regask.com\/?p=7963"},"modified":"2025-01-28T18:18:44","modified_gmt":"2025-01-28T10:18:44","slug":"adopcion-de-las-directrices-internacionales-de-la-tga","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/tga-international-guidelines-adoption\/","title":{"rendered":"La TGA adopta directrices cient\u00edficas internacionales"},"content":{"rendered":"

El 13 de enero de 2025, el Administraci\u00f3n de Productos Terap\u00e9uticos (TGA)<\/a> La TGA ha anunciado la adopci\u00f3n de varias directrices cient\u00edficas internacionales para armonizar la normativa australiana con las mejores pr\u00e1cticas globales. La adopci\u00f3n, vigente a partir de enero de 2025, busca mejorar la calidad y la seguridad de los productos terap\u00e9uticos comercializados en Australia. Estas directrices complementan las normas existentes y reflejan el compromiso de la TGA con una estricta supervisi\u00f3n regulatoria.<\/p>\n

Directrices adoptadas<\/strong><\/h3>\n

13 de enero de 2025<\/strong><\/h4>\n
    \n
  • ICH Q3B (R2); CPMP\/ICH\/2738\/99<\/strong>:Impurezas en nuevos medicamentos<\/li>\n
  • ICH S4; CPMP\/ICH\/300\/95<\/strong>:Duraci\u00f3n de las pruebas de toxicidad cr\u00f3nica en animales (roedores y no roedores)<\/li>\n
  • ICH S7A; CPMP\/ICH\/539\/00<\/strong>: Estudios de farmacolog\u00eda de seguridad para productos farmac\u00e9uticos humanos<\/li>\n
  • ICH S7B; CPMP\/ICH\/423\/02<\/strong>: Evaluaci\u00f3n no cl\u00ednica del riesgo de prolongaci\u00f3n del intervalo QT en productos farmac\u00e9uticos humanos<\/li>\n
  • ICH S8; CHMP\/167235\/2004<\/strong>: Estudios de inmunotoxicidad para productos farmac\u00e9uticos humanos<\/li>\n<\/ul>\n

    10 de enero de 2025<\/strong><\/h4>\n
      \n
    • ICH Q3A (R2); CPMP\/ICH\/2737\/99<\/strong>:Impurezas en nuevas sustancias farmacol\u00f3gicas<\/li>\n
    • ICH Q5B; CPMP\/ICH\/139\/95<\/strong>:Calidad de productos biotecnol\u00f3gicos: an\u00e1lisis de constructos de expresi\u00f3n en l\u00edneas celulares<\/li>\n
    • ICH Q5D; CPMP\/ICH\/294\/95<\/strong>: Caracterizaci\u00f3n de sustratos celulares para productos biotecnol\u00f3gicos\/biol\u00f3gicos<\/li>\n
    • ICH Q6A; CPMP\/ICH\/367\/96<\/strong>:Especificaciones para sustancias qu\u00edmicas en nuevos medicamentos y sustancias<\/li>\n
    • ICH Q6B; CPMP\/ICH\/365\/96<\/strong>: Especificaciones para productos biotecnol\u00f3gicos\/biol\u00f3gicos<\/li>\n<\/ul>\n

      9 de enero de 2025<\/strong><\/h4>\n
        \n
      • EMA\/HMPC\/201116\/2005 Rev.2; EMA\/CVMP\/814\/00 Rev.2<\/strong>:Calidad de los productos medicinales a base de plantas y de los productos medicinales a base de plantas tradicionales<\/li>\n<\/ul>\n

        \u00bfQu\u00e9 significa esto para los fabricantes?<\/strong><\/h3>\n

        La adopci\u00f3n de estas directrices representa un avance significativo para garantizar que los productos terap\u00e9uticos cumplan con los m\u00e1s altos est\u00e1ndares globales. Esto impactar\u00e1 diversas \u00e1reas, entre ellas:<\/p>\n

          \n
        • An\u00e1lisis de impurezas de f\u00e1rmacos<\/li>\n
        • Protocolos de pruebas de toxicidad (cr\u00f3nica y no cl\u00ednica)<\/li>\n
        • Evaluaciones farmacol\u00f3gicas de seguridad<\/li>\n
        • Especificaciones de calidad para productos qu\u00edmicos y biotecnol\u00f3gicos<\/li>\n
        • Calidad de los productos medicinales a base de hierbas<\/li>\n<\/ul>\n

          Se anima a los fabricantes a revisar e integrar estas normas con prontitud en sus procesos de desarrollo y prueba. Este enfoque proactivo garantizar\u00e1 el cumplimiento de las regulaciones de la TGA y facilitar\u00e1 un acceso sin problemas al mercado.<\/p>","protected":false},"excerpt":{"rendered":"

          El 13 de enero de 2025, la Administraci\u00f3n de Productos Terap\u00e9uticos (TGA) anunci\u00f3 la adopci\u00f3n de varias directrices cient\u00edficas internacionales para armonizar la normativa australiana con las mejores pr\u00e1cticas globales. La adopci\u00f3n, vigente a partir de enero de 2025, busca mejorar la calidad y la seguridad de los productos terap\u00e9uticos comercializados en Australia. Estas directrices complementan las normas existentes y reflejan el compromiso de la TGA con\u2026<\/p>","protected":false},"author":43,"featured_media":7976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37,33,511],"tags":[609],"class_list":["post-7963","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-personal-care-cosmetics","category-news","category-australia-regulations","tag-guideline"],"acf":[],"yoast_head":"\nTGA Aligns with International Scientific Guidelines | RegASK<\/title>\n<meta name=\"description\" content=\"TGA adopts international guidelines to enhance quality of therapeutic goods in Australia. Effective January 2025. 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