Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Laws & Regulations CDE Guidance Marketing Approval Clinical Trials Bioequivalence (BE) Post-market Drug Registration New DrugsMonthly 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
- Online Conference | China Drug Regulation and Pharmaceutical Market
- China Cracks Down on Monopolies in Active Pharmaceutical Ingredient Industry
- Monthly Recap: China Pharmaceutical Regulatory Updates | Sept. 2021
- Monthly Report: New Drug Approvals in China | Sept. 2021
- China Chemical Drug Registration Classification