{"id":8174,"date":"2025-04-04T03:30:11","date_gmt":"2025-04-03T19:30:11","guid":{"rendered":"https:\/\/regask.com\/?p=8174"},"modified":"2025-04-09T14:29:54","modified_gmt":"2025-04-09T06:29:54","slug":"mexiko-gmp-konformitat-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/mexico-gmp-compliance-2025\/","title":{"rendered":"COFEPRIS (Mexiko) ver\u00f6ffentlicht Richtlinien f\u00fcr GMP-Dokumente\u2026"},"content":{"rendered":"<p data-pm-slice=\"1 3 []\">Am 20. M\u00e4rz 2025 ver\u00f6ffentlichte die mexikanische Bundeskommission zum Schutz vor Gesundheitsrisiken (COFEPRIS) im Amtsblatt (DOF) das \u00dcbereinkommen zur Herausgabe von Leitlinien f\u00fcr die Einreichung von Dokumenten zur Gew\u00e4hrleistung guter Herstellungspraxis (GMP) f\u00fcr Wirkstoffe, Arzneimittel und Medizinprodukte. Diese Leitlinien gelten f\u00fcr Antr\u00e4ge auf neue Gesundheitsregistrierungen sowie deren Erweiterungen und \u00c4nderungen. Die neu geschaffenen Vorschriften definieren die Anforderungen und Kriterien f\u00fcr die Einreichung von GMP-Dokumenten und zielen darauf ab, die Einhaltung internationaler Standards zu vereinfachen und die Zusammenarbeit mit anerkannten Regulierungsbeh\u00f6rden zu verbessern.<\/p>\n<h4><strong>Wichtige Highlights<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Die Richtlinien legen die erforderlichen Unterlagen fest, darunter Zertifikate f\u00fcr gute Herstellungspraxis oder gleichwertige Dokumente, die f\u00fcr pharmazeutische Inhaltsstoffe, Arzneimittel und Medizinprodukte bei Antr\u00e4gen, Erneuerungen und \u00c4nderungen der Gesundheitsregistrierung erforderlich sind.<\/li>\n<li>Der Schwerpunkt liegt auf der Einhaltung internationaler GMP-Standards, um die Produktsicherheit, Wirksamkeit und Konsistenz w\u00e4hrend des gesamten Herstellungsprozesses zu gew\u00e4hrleisten.<\/li>\n<li>Zu den betroffenen Produktkategorien geh\u00f6ren:\n<ul data-spread=\"false\">\n<li>Pharmazeutische Wirkstoffe (APIs)<\/li>\n<li>Over-the-Counter-Medikamente (OTC)<\/li>\n<li>Verschreibungspflichtige Medikamente<\/li>\n<li>Verschiedene medizinische Ger\u00e4te, darunter Diagnose- und Therapieger\u00e4te<\/li>\n<\/ul>\n<\/li>\n<li>Die Verordnung f\u00f6rdert die Abstimmung mit weltweit anerkannten Regulierungsbeh\u00f6rden und erm\u00f6glicht so potenziell einen leichteren Zugang konformer Produkte zu internationalen M\u00e4rkten.<\/li>\n<li>Hersteller werden dazu angehalten, diese Richtlinien strikt einzuhalten, um ihren Registrierungsstatus aufrechtzuerhalten und einen reibungsloseren Genehmigungsprozess f\u00fcr neue oder ge\u00e4nderte Gesundheitsregistrierungen sicherzustellen.<\/li>\n<\/ul>\n<h4><strong>N\u00e4chste Schritte<\/strong><\/h4>\n<ul data-spread=\"false\">\n<li>Hersteller sollten ihre GMP-Dokumentation pr\u00fcfen und aktualisieren, um sie an die neuen COFEPRIS-Richtlinien anzupassen.<\/li>\n<li>Unternehmen sollten sicherstellen, dass ihre Produktionsprozesse und Qualit\u00e4tskontrollsysteme den \u00fcberarbeiteten gesetzlichen Erwartungen entsprechen.<\/li>\n<li>Eine genaue \u00dcberwachung regulatorischer Aktualisierungen und eine proaktive Zusammenarbeit mit COFEPRIS sind f\u00fcr die Einhaltung der Vorschriften und die Optimierung der Genehmigungsprozesse von entscheidender Bedeutung.<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Am 20. M\u00e4rz 2025 ver\u00f6ffentlichte die mexikanische Bundeskommission zum Schutz vor Gesundheitsrisiken (COFEPRIS) im Amtsblatt (DOF) das \u00dcbereinkommen zur Herausgabe von Leitlinien f\u00fcr die Einreichung von Dokumenten zur Gew\u00e4hrleistung guter Herstellungspraktiken (GMP) f\u00fcr Wirkstoffe, Arzneimittel und Medizinprodukte. Diese Leitlinien gelten f\u00fcr Antr\u00e4ge auf neue Gesundheitsregistrierungen sowie\u2026<\/p>","protected":false},"author":43,"featured_media":8207,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[521,35],"tags":[609],"class_list":["post-8174","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mexico-regulations","category-pharma-biotech-latest-insights","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Mexico GMP 2025: Key Updates | RegASK<\/title>\n<meta name=\"description\" content=\"Stay compliant! COFEPRIS updates GMP rules in 2025. 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