{"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":"richtlinien-fur-die-zellgentherapie-in-malaysia","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/malaysia-cell-gene-therapy-guidelines\/","title":{"rendered":"Malaysias NPRA beginnt \u00f6ffentliche Konsultation zur Aktualisierung \u2026"},"content":{"rendered":"<p>Am 7. Oktober 2024 wird die <a href=\"https:\/\/regask.com\/de\/npra-malaysia-published-biosimilar-guidance-document-and-guidelines\/\">Nationale Arzneimittelregulierungsbeh\u00f6rde (NPRA)<\/a> von Malaysia k\u00fcndigte den Start einer \u00f6ffentlichen Konsultation f\u00fcr die 2. Ausgabe des <strong>\u201eLeitfaden und Richtlinien f\u00fcr die Registrierung von Zell- und Gentherapieprodukten (CGTPs) in Malaysia.\u201c<\/strong> Die Konsultation dauert vom<strong> 7. Oktober 2024 bis 7. November 2024 <\/strong>Damit wird den Beteiligten eine letzte Chance geboten, ihre Meinung zu \u00e4u\u00dfern, bevor die Richtlinien fertiggestellt werden. CGTPs, die gem\u00e4\u00df dem malaysischen Sale of Drugs Act von 1952 und den Control of Drugs and Cosmetics Regulations von 1984 als biologische Produkte eingestuft werden, spielen eine entscheidende Rolle f\u00fcr den medizinischen Fortschritt und erfordern eine strenge \u00dcberwachung, um ihre Sicherheit, Wirksamkeit und Qualit\u00e4t zu gew\u00e4hrleisten.<\/p>\n<p>Zu den wichtigsten \u00c4nderungsvorschl\u00e4gen geh\u00f6ren:<\/p>\n<ul>\n<li><strong>Verfeinerung der Vorschriften<\/strong>: Anpassungen f\u00fcr CGTPs der Klasse I, einschlie\u00dflich Aktualisierungen der regulatorischen und Sicherheitsrahmen.<\/li>\n<li><strong>\u00dcberarbeitungen der GMP- und GLP-Anforderungen<\/strong>: Sicherstellung aktualisierter Standards f\u00fcr die Gute Herstellungspraxis (GMP) und Kl\u00e4rung der Anforderungen der Guten Laborpraxis (GLP).<\/li>\n<li><strong>Richtlinienaktualisierungen<\/strong>: Entfernung veralteter Leitlinien f\u00fcr gute Gewebepraxis (GTP).<\/li>\n<\/ul>\n<p>An der Konsultation ist ein breites Spektrum von Interessengruppen beteiligt, darunter CGTP-Hersteller, Pharmaunternehmen, Verb\u00e4nde, Praktiker, Forscher und Wissenschaftler. Das Dokument entspricht nationalen und internationalen Richtlinien, beispielsweise denen der <strong>Weltgesundheitsorganisation (WHO)<\/strong>, <strong>Internationale Konferenz zur Harmonisierung (ICH)<\/strong>, <strong>US-amerikanische FDA<\/strong>, Und <strong>Europ\u00e4ische Arzneimittel-Agentur (EMA)<\/strong>.<\/p>\n<p>Dieses Update spiegelt Malaysias Engagement f\u00fcr hohe Standards im sich entwickelnden Bereich der Zell- und Gentherapie wider. F\u00fcr alle Beteiligten bietet diese Konsultation eine wichtige Gelegenheit, zur zuk\u00fcnftigen CGTP-Regulierung im Land beizutragen.<\/p>\n<p>F\u00fcr weitere Informationen wenden Sie sich bitte an 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 v28.3 (Yoast SEO v28.3) - 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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