{"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":"ubernahme-der-internationalen-tga-leitlinien","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/tga-international-guidelines-adoption\/","title":{"rendered":"TGA \u00fcbernimmt internationale wissenschaftliche Richtlinien"},"content":{"rendered":"<p>Am 13. Januar 2025 wird die <a href=\"https:\/\/regask.com\/de\/australien-tga-genehmigt-anspruch\/\">Therapeutische G\u00fcterverwaltung (TGA)<\/a> hat die Einf\u00fchrung mehrerer internationaler wissenschaftlicher Leitlinien angek\u00fcndigt, um die australischen Vorschriften an globale Best Practices anzupassen. Die Einf\u00fchrung, die im Januar 2025 in Kraft tritt, zielt darauf ab, die Qualit\u00e4t und Sicherheit der in Australien vertriebenen therapeutischen Produkte zu verbessern. Diese Leitlinien erg\u00e4nzen bestehende Standards und spiegeln das Engagement der TGA f\u00fcr eine strenge Regulierungsaufsicht wider.<\/p>\n<h3><strong>Angenommene Richtlinien<\/strong><\/h3>\n<h4><strong>13. Januar 2025<\/strong><\/h4>\n<ul>\n<li><strong>ICH Q3B (R2); CPMP\/ICH\/2738\/99<\/strong>: Verunreinigungen in neuen Arzneimitteln<\/li>\n<li><strong>ICH S4; CPMP\/ICH\/300\/95<\/strong>: Dauer der chronischen Toxizit\u00e4tstests bei Tieren (Nagetiere und Nicht-Nagetiere)<\/li>\n<li><strong>ICH S7A; CPMP\/ICH\/539\/00<\/strong>: Sicherheitspharmakologische Studien f\u00fcr Humanarzneimittel<\/li>\n<li><strong>ICH S7B; CPMP\/ICH\/423\/02<\/strong>: Nichtklinische Bewertung des Risikos einer QT-Intervallverl\u00e4ngerung in Humanpharmazeutika<\/li>\n<li><strong>ICH S8; CHMP\/167235\/2004<\/strong>: Immuntoxizit\u00e4tsstudien f\u00fcr Humanpharmazeutika<\/li>\n<\/ul>\n<h4><strong>10. Januar 2025<\/strong><\/h4>\n<ul>\n<li><strong>ICH Q3A (R2); CPMP\/ICH\/2737\/99<\/strong>: Verunreinigungen in neuen Arzneimittelwirkstoffen<\/li>\n<li><strong>ICH Q5B; CPMP\/ICH\/139\/95<\/strong>: Qualit\u00e4t biotechnologischer Produkte \u2013 Analyse von Expressionskonstrukten in Zelllinien<\/li>\n<li><strong>ICH Q5D; CPMP\/ICH\/294\/95<\/strong>: Charakterisierung von Zellsubstraten f\u00fcr biotechnologische\/biologische Produkte<\/li>\n<li><strong>ICH Q6A; CPMP\/ICH\/367\/96<\/strong>: Spezifikationen f\u00fcr chemische Substanzen in neuen Arzneimitteln und Substanzen<\/li>\n<li><strong>ICH Q6B; CPMP\/ICH\/365\/96<\/strong>: Spezifikationen f\u00fcr biotechnologische\/biologische Produkte<\/li>\n<\/ul>\n<h4><strong>9. Januar 2025<\/strong><\/h4>\n<ul>\n<li><strong>EMA\/HMPC\/201116\/2005 Rev. 2; EMA\/CVMP\/814\/00 Rev.2<\/strong>: Qualit\u00e4t pflanzlicher Arzneimittel und traditioneller pflanzlicher Arzneimittel<\/li>\n<\/ul>\n<h3><strong>Was bedeutet das f\u00fcr Hersteller?<\/strong><\/h3>\n<p>Die Verabschiedung dieser Leitlinien stellt einen bedeutenden Fortschritt dar, um sicherzustellen, dass therapeutische Produkte den h\u00f6chsten globalen Standards entsprechen. Dies wird sich auf verschiedene Bereiche auswirken, darunter:<\/p>\n<ul>\n<li>Analyse von Arzneimittelverunreinigungen<\/li>\n<li>Protokolle f\u00fcr Toxizit\u00e4tstests (chronisch und nichtklinisch)<\/li>\n<li>Sicherheitspharmakologische Bewertungen<\/li>\n<li>Qualit\u00e4tsspezifikationen f\u00fcr chemische und biotechnologische Produkte<\/li>\n<li>Qualit\u00e4t pflanzlicher Arzneimittel<\/li>\n<\/ul>\n<p>Hersteller werden ermutigt, diese Standards zeitnah zu pr\u00fcfen und in ihre Entwicklungs- und Testprozesse zu integrieren. Dieser proaktive Ansatz gew\u00e4hrleistet die Einhaltung der TGA-Vorschriften und unterst\u00fctzt einen reibungslosen Marktzugang.<\/p>","protected":false},"excerpt":{"rendered":"<p>Am 13. Januar 2025 gab die australische Arzneimittelbeh\u00f6rde (Therapeutic Goods Administration, TGA) die \u00dcbernahme mehrerer internationaler wissenschaftlicher Leitlinien bekannt, um die australischen Vorschriften an internationale Best Practices anzupassen. Die im Januar 2025 in Kraft getretenen Leitlinien sollen die Qualit\u00e4t und Sicherheit der in Australien vermarkteten Arzneimittel verbessern. Sie erg\u00e4nzen bestehende Standards und unterstreichen das Engagement der TGA f\u00fcr\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":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>TGA 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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