Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications China will carry out pre-approval inspections on R&D and manufacturing sites involved in drug registration applications. When necessary, the inspections can extend to relevant API, excipient, packaging material manufacturers, suppliers, and contract organizations.
Dec 24, 2021
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
China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials On Sept. 18, the National Medical Products Administration (NMPA) released the List of Medical Devices Exempted from Clinical Evaluation and the List of In Vitro Diagnostic Reagents Exempted from Clinical Evaluation. Both are scheduled to take effect on Oct. 1, 2021.
Sep 24, 2021
Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.
Apr 12, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021 In Mar. 2021, the Center for Drug Evaluation released a total of seven announcements including contents such as technical requirements for drug research & evaluation. ChemLinked BaiPharm team collected the documents and summarized their keynotes.
Apr 08, 2021
China Rejects Medical Device Registration Applications with Data Authenticity Issues On Jan. 15, 2021, China National Medical Products Administration rejected a company’s medical device registration application because of the data authenticity issue in the clinical trial.
Mar 24, 2021
China CDE to Disclose New Drugs' Technical Review Reports China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
Mar 08, 2021
- China to Initiate Pre-Approval Inspections Based on Risk Levels of Drug Registration Applications
- China Adds 74 Drugs to National Reimbursement Drug List (NRDL)
- Monthly Recap: China Pharmaceutical Regulatory Updates | Nov. 2021
- China's Insulin VBP Saw Average Price Cut of 48.75%
- Monthly Report: New Drug Approvals in China | Nov. 2021