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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Laws & Regulations CDE Guidance Marketing Approval Clinical Trials Bioequivalence (BE) Post-market Drug Registration New Drugs
Monthly Recap: China Pharmaceutical Regulatory Updates | Sept. 2021 1. China's eCTD Format for Drug Marketing Application Dossiers; 2.1. NMPA Underlines Points for Attention on Implementing Administrative Measures for Medical Device Registration and Filing and Administrative Measures for In Vitro Diagnostic Reagent Registration and Filing. 2.2. NMPA Rolls Out the List of Medical Devices Exempted from Clinical Evaluation3 and the List of In Vitro Diagnostic Reagents Exempted from Clinical Trials; 2.3. NMPA Releases Format Requirements for Medical Devices’ or IVD Reagents’ Registration Application Dossiers and Approval Documents; 2.4. Guidelines on Medical Devices and IVD Reagents; 2.5. NMPA Releases Medical Device Industry Standards; 2.6. NMPA, NHC and NHSA Stipulates Unique Device Identifiers; 3. NMPA granted Aloe Vera Pearl Capsules OTC Status; 4.A Collection of Sept. Guidelines Released by NMPA or CDE
Oct 31, 2021
INDUSTRY
Laws & Regulations Post-market
Adverse Drug Reaction in China: Important Numbers from 2020 Report In 2020, China's National Monitoring System of Adverse Drug Reaction (ADR) received a total number of 1.676 million reports of ADR events.
Mar 31, 2021
REGULATION
Laws & Regulations MAH Pharmacovigilance Post-market
China Requires Drug Market Authorization Holders to Submit Annual Report On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.
Mar 08, 2021
REGULATION
MAH Pharmacovigilance Post-market
China Consults on the Draft of Good Pharmacovigilance Practices On Dec. 1, 2020, the National Medical Products Administration (NMPA) issued the draft of Good Pharmacovigilance Practices (GVP) for public comments. Stakeholders could submit feedback to NMPA before Dec. 18, 2020.
Mar 08, 2021
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