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
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 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 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