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In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations
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Consulting of current regulation and policy

NMPA related application for clinical trial and marketing approval

Compliance support from product development to commercialization

Post-market drug safety and risk management

Latest News

REGULATION
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

REGULATION
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