Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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.
Feb 24, 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | July 2021
- China Drug Evaluation Report 2020-Reform of Drug Review & Approval System
- Monthly Report: New Drug Approvals in China | Aug. 2021
- Monthly Recap: China Pharmaceutical Regulatory Updates | Aug. 2021
- China to Exempt Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials