Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China CFDI 2021 Drug Inspection Overview In 2021, China CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections.
Jun 30, 2022
Law & Regulation CDE Guideline Pharmacopoeia Reference Listed Drug (RLD) MAH Marketing Approval CMC Clinical Trial Generic Drug Cell Therapy Gene Therapy Drug RegistrationMonthly Recap: China Pharmaceutical Regulatory Updates | May 2022 Check out the May updates on pharma regulations in China: NMPA publishes MedDRA Coding Guidance for ADR Reports...
Jun 08, 2022
China Specifies GMP Regulations on Investigational Products Used in Clinical Trials On May 27, China NMPA released the Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Drugs Used in Clinical Trials, which will take effect on July 1, 2022.
Jun 06, 2022
Law & Regulation CDE Guideline Reference Listed Drug (RLD) MAH Pharmacovigilance Marketing Approval CMC Bioequivalence (BE) Post-market Generic Drug Biosimilar Cancer New DrugMonthly Recap: China Pharmaceutical Regulatory Updates | April 2022 Check out China's pharmaceutical regulation updates April 2022: China NMPA releases Pharmacovigilance Inspection Guidelines...
May 05, 2022
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 Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- Generic Drug Application (ANDA) in China
- Monthly Report: New Drug Approvals in China | April 2022
- China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
- Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022