{"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":"adoption-des-directives-internationales-de-la-tga","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/tga-international-guidelines-adoption\/","title":{"rendered":"La TGA adopte des directives scientifiques internationales"},"content":{"rendered":"

Le 13 janvier 2025, le Administration des produits th\u00e9rapeutiques (TGA)<\/a> La TGA a annonc\u00e9 l'adoption de plusieurs directives scientifiques internationales visant \u00e0 aligner la r\u00e9glementation australienne sur les meilleures pratiques mondiales. Cette adoption, qui entrera en vigueur en janvier 2025, vise \u00e0 am\u00e9liorer la qualit\u00e9 et la s\u00e9curit\u00e9 des produits th\u00e9rapeutiques commercialis\u00e9s en Australie. Ces directives compl\u00e8tent les normes existantes et refl\u00e8tent l'engagement de la TGA \u00e0 maintenir une surveillance r\u00e9glementaire rigoureuse.<\/p>\n

Lignes directrices adopt\u00e9es<\/strong><\/h3>\n

13 janvier 2025<\/strong><\/h4>\n
    \n
  • ICH Q3B (R2); CPMP\/ICH\/2738\/99<\/strong>: Impuret\u00e9s dans les nouveaux produits pharmaceutiques<\/li>\n
  • ICH S4; CPMP\/ICH\/300\/95<\/strong>:Dur\u00e9e des tests de toxicit\u00e9 chronique chez les animaux (rongeurs et non-rongeurs)<\/li>\n
  • ICH S7A; CPMP\/ICH\/539\/00<\/strong>: \u00c9tudes de pharmacologie de s\u00e9curit\u00e9 pour les produits pharmaceutiques \u00e0 usage humain<\/li>\n
  • ICH S7B; CPMP\/ICH\/423\/02<\/strong>:\u00c9valuation non clinique du risque d'allongement de l'intervalle QT dans les produits pharmaceutiques \u00e0 usage humain<\/li>\n
  • ICH S8; CHMP\/167235\/2004<\/strong>: \u00c9tudes d'immunotoxicit\u00e9 pour les produits pharmaceutiques \u00e0 usage humain<\/li>\n<\/ul>\n

    10 janvier 2025<\/strong><\/h4>\n
      \n
    • ICH Q3A (R2); CPMP\/ICH\/2737\/99<\/strong>: Impuret\u00e9s dans les nouvelles substances m\u00e9dicamenteuses<\/li>\n
    • ICH Q5B; CPMP\/ICH\/139\/95<\/strong>: Qualit\u00e9 des produits biotechnologiques \u2013 analyse des structures d\u2019expression dans les lign\u00e9es cellulaires<\/li>\n
    • ICH Q5D; CPMP\/ICH\/294\/95<\/strong>:Caract\u00e9risation des substrats cellulaires pour produits biotechnologiques\/biologiques<\/li>\n
    • ICH Q6A; CPMP\/ICH\/367\/96<\/strong>:Sp\u00e9cifications des substances chimiques contenues dans les nouveaux m\u00e9dicaments et substances<\/li>\n
    • ICH Q6B; CPMP\/ICH\/365\/96<\/strong>:Sp\u00e9cifications pour les produits biotechnologiques\/biologiques<\/li>\n<\/ul>\n

      9 janvier 2025<\/strong><\/h4>\n
        \n
      • EMA\/HMPC\/201116\/2005 R\u00e9v. 2\u00a0; EMA\/CVMP\/814\/00 R\u00e9v.2<\/strong>: Qualit\u00e9 des m\u00e9dicaments \u00e0 base de plantes m\u00e9dicinales et des m\u00e9dicaments traditionnels \u00e0 base de plantes<\/li>\n<\/ul>\n

        Qu'est-ce que cela signifie pour les fabricants ?<\/strong><\/h3>\n

        L\u2019adoption de ces lignes directrices repr\u00e9sente une avanc\u00e9e significative pour garantir que les produits th\u00e9rapeutiques r\u00e9pondent aux normes mondiales les plus \u00e9lev\u00e9es. Cela aura des r\u00e9percussions dans plusieurs domaines, notamment :<\/p>\n

          \n
        • Analyse des impuret\u00e9s des m\u00e9dicaments<\/li>\n
        • Protocoles de tests de toxicit\u00e9 (chronique et non clinique)<\/li>\n
        • \u00c9valuations de la s\u00e9curit\u00e9 pharmacologique<\/li>\n
        • Sp\u00e9cifications de qualit\u00e9 pour les produits chimiques et biotechnologiques<\/li>\n
        • Qualit\u00e9 des produits m\u00e9dicinaux \u00e0 base de plantes<\/li>\n<\/ul>\n

          Les fabricants sont encourag\u00e9s \u00e0 examiner et \u00e0 int\u00e9grer rapidement ces normes dans leurs processus de d\u00e9veloppement et de test. Cette approche proactive garantira la conformit\u00e9 avec les r\u00e9glementations de la TGA et favorisera un acc\u00e8s fluide au march\u00e9.<\/p>","protected":false},"excerpt":{"rendered":"

          On January 13, 2025, the Therapeutic Goods Administration (TGA) has announced the adoption of several international scientific guidelines to align Australian regulations with global best practices. The adoption, effective January 2025, aims to enhance the quality and safety of therapeutic goods marketed in Australia. These guidelines complement existing standards and reflect the TGA\u2019s commitment to…<\/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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