Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Implements the Newly Released Good Pharmacovigilance Practice The Chinese GVP applies to Marketing Authorization Holders’s pharmacovigilance activities about medicinal products and drug registration applicants with authorization to carry out clinical trials.
May 28, 2021
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2021 In Apr. 2021, China National Medical Products Administration (NMPA) and its subordinate body Center for Drug Evaluations (CDE) published a series of regulations on medical products, including pediatric medicine and biosimilars.
May 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 Launches Medical Device Master File System On Mar. 12, 2021, China National Medical Products Administration (NMPA) announced guidance on filing medical device master files (MAFs), which specified content, format and procedures of this new MAF system. The announcement took effect on the same day.
Mar 26, 2021
China's 2021 Two Sessions: What Can We Expect for the Medical and Health Sectors? Chinese Premier Li Keqiang pointed out nine major objectives in the medical and health sectors in 2021 in the Government Work Report on March 5th.
Mar 15, 2021
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 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