What China NMPA Drug Registration Regulation 2020 - Marketing Authorisation Holder System and Priority Review requires
China's Drug Registration Regulation (Order No. 27, 1 July 2020) issued by the National Medical Products Administration (NMPA - formerly CFDA) establishes the Marketing Authorisation Holder (MAH) system separating drug approval from…
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Pillar: Pharmaceuticals & Life Sciences · Authority: National Medical Products Administration (NMPA), People's Republic of China · Version: 1.0.0 · Last updated:
Primary source: https://english.nmpa.gov.cn/
SHA-256 integrity: 6d2c030ce0f1bbcd0d45c2e150e9f430d6377cbcfc1ce43a598bf87191b50bd4
Primary Citations — 6 traced to source
- Article 4 (drug classification); Articles 68-78 (priority review); Article 84 (data exclusivity 6 years); Chapter VI (imported drugs); Chapter VIII (post-approval changes); Chapter IX (pharmacovigilance) — Drug Registration Regulation (NMPA Order No. 27, 2020) - NMPA
- Article 77 (MAH pharmacovigilance obligations); Article 98 (GMP compliance mandatory); Chapter XI (administrative and criminal penalties up to CNY 3 million) — Drug Administration Law 2019 (Revised) - National People's Congress
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