{"id":8048,"date":"2025-03-06T19:30:50","date_gmt":"2025-03-06T11:30:50","guid":{"rendered":"https:\/\/regask.com\/?p=8048"},"modified":"2025-03-10T19:33:39","modified_gmt":"2025-03-10T11:33:39","slug":"leitfaden-zur-registrierung-von-cde-biologika-in-china","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/china-cde-biologics-registration-guide\/","title":{"rendered":"CDE (China) ver\u00f6ffentlicht Leitfaden zur Registrierung von Biologika \u2026"},"content":{"rendered":"<p data-start=\"151\" data-end=\"567\">Am 9. Februar 2025 gab das Center for Drug Evaluation (CDE) die Ver\u00f6ffentlichung des <strong data-start=\"238\" data-end=\"318\">\u201eLeitfaden f\u00fcr die Abnahmepr\u00fcfung der Zulassung biologischer Produkte (Studie)\u201c<\/strong> (Nr. 15 von 2025), in Kraft treten am <strong data-start=\"359\" data-end=\"377\">10. M\u00e4rz 2025<\/strong>Dieses wichtige Update zielt darauf ab, <strong data-start=\"411\" data-end=\"452\">Standardisierung des formalen \u00dcberpr\u00fcfungsprozesses<\/strong> f\u00fcr die Zulassung von Biologika und bietet Antragstellern klarere Anleitungen zur Gew\u00e4hrleistung der Einhaltung gesetzlicher Vorschriften.<\/p>\n<p data-start=\"569\" data-end=\"611\">Zu den wichtigsten Punkten der Richtlinie z\u00e4hlen:<\/p>\n<ul data-start=\"613\" data-end=\"992\">\n<li data-start=\"613\" data-end=\"724\"><strong data-start=\"615\" data-end=\"650\">Verfeinerte Einreichungsanforderungen<\/strong> um die Abnahmepr\u00fcfung bei der Registrierung biologischer Produkte zu rationalisieren.<\/li>\n<li data-start=\"725\" data-end=\"862\">Anwendbarkeit auf <strong data-start=\"744\" data-end=\"785\">alle Kategorien biologischer Produkte<\/strong>, was Hersteller und Entwickler dazu zwingt, ihre Compliance-Strategien zu \u00fcberdenken.<\/li>\n<li data-start=\"863\" data-end=\"992\">Ein <strong data-start=\"868\" data-end=\"909\">Umsetzungstermin 10. M\u00e4rz 2025<\/strong>, sodass den Beteiligten Zeit bleibt, ihre Dokumentation an die neuen Standards anzupassen.<\/li>\n<\/ul>\n<p data-start=\"994\" data-end=\"1216\">Diese Regulierungsinitiative spiegelt das anhaltende Engagement von CDE wider, <strong data-start=\"1058\" data-end=\"1104\">Verbesserung der Aufsicht und der regulatorischen Klarheit<\/strong> innerhalb des Biologikasektors, was m\u00f6glicherweise Auswirkungen auf die Zeitpl\u00e4ne der Produktentwicklung und die Strategien zum Markteintritt hat.<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Am 9. Februar 2025 ver\u00f6ffentlichte das Center for Drug Evaluation (CDE) die \u201cLeitlinie f\u00fcr die Annahmepr\u00fcfung der Zulassung biologischer Arzneimittel (Studie)\u201d (Nr. 15 von 2025), die am 10. M\u00e4rz 2025 in Kraft treten soll. Diese wichtige Aktualisierung zielt darauf ab, das formale Pr\u00fcfverfahren f\u00fcr die Zulassung biologischer Arzneimittel zu standardisieren und Antragstellern eine klarere Orientierung zu bieten.<\/p>","protected":false},"author":43,"featured_media":8110,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[514,35],"tags":[496,498,609],"class_list":["post-8048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-china-regulations","category-pharma-biotech-latest-insights","tag-market-authorization-regs","tag-drug-development-regs","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>China CDE Issues Biologics Registration Guideline | RegASK<\/title>\n<meta name=\"description\" content=\"China CDE releases new guidelines to streamline biologics registration. 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