Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Consults on GMP for Pharmaceutical Packaging Materials On June 2, China NMPA released the draft of Good Manufacturing Practice (GMP) of Pharmaceutical Packaging Materials for public comments. The Packaging GMP specifies basic requirements for the manufacture management and quality control of pharmaceutical packaging materials.
Jun 09, 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
China Implements Guidelines on Immune-related Adverse Event (irADR) in Immuno-oncology In the Guidelines, China CDE proposes the definition of irAE as all levels of adverse drug reactions (ADR) that are confirmed to have causal connections with the immune mechanism.
May 20, 2022
China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports MedDRA is a standardized medical terminology developed by the ICH. China's Guidance is for MAHs to use MedDRA coded terms in post-marketing adverse reaction reports.
May 18, 2022
Law & Regulation MAH Pharmacovigilance Marketing Approval Priority Review and Approval Medical Insurance Innovative Drug Generic Drug Rare Disease Drug Registration New DrugChina Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law Find out the highlights in revised draft of the Regulations for Implementation of the Drug Administration Law: pharmaceutical innovation, acceptance of foreign clinical data, support the development of pediatric and rare disease drugs...
May 13, 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
Beijing IP Court Rules on China's First Drug Patent Linkage Litigation Case China's IP court rules that Wenzhou Haihe Pharma’s generic drug is outside Chugai Pharma's Patent Claim 1 for the brand-name version of Eldecalcitol Soft Capsules.
Apr 24, 2022
- 2021 China CDE Drug Evaluation Report
- Monthly Report: New Drug Approvals in China | June 2022
- China Kicks off the 7th Round of Volume-based Procurement (VBP) of Drugs
- China Emphasizes Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List (NRDL)
- Licensing Deals Involving Chinese Pharma Companies in H1 2022