Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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 of 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 Releases Second Batch of 17 Encouraged Generic Drugs China officially issued the Second Batch of 17 Encouraged Generic Drugs, which could benefit from preferential policy support in terms of priority review and approval, clinical trials and critical generic technology researches in China.
Mar 26, 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 Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
- In Light of the 14th Rare Disease Day, How Is China Doing on Rare Disease Drugs?
- China to Carry out National Insulin Procurement
- Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021
- China's 2021 Two Sessions: What Can We Expect for the Medical and Health Sectors?
- China Launches Medical Device Master File System