Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Implements GMP Appendix for Investigational Products Used in Clinical Trials On July 1, 2022, the Appendix to GMP for Pharmaceuticals: Investigational Products Used in Clinical Trials comes into effect. The Appendix is a supporting document for China's pharmaceutical GMP, which was revised in 2010 and has been effective since 2011.
Jul 01, 2022
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
European Commission Publishes Draft on Labeling Requirements for IMPs With the application of the EU Clinical Trials Regulation some labelling requirements for IMPs have changed, in particular regarding the expiry date. Now an initiative eliminates the obligation to include an expiry date on the immediate packaging of IMPs in specific circumstances.
Jun 22, 2022
EMA Issues New Guidance Documents for GCP Inspections Following the previously published list of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. The annexes compile specific items that may be verified at the sponsor / CRO / investigator site and clinical laboratories.
Jun 22, 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
Law & Regulation Marketing Approval Clinical Trial Priority Review and Approval NRDL Volume-Based Procurement Medical Insurance Innovative Drug API Rare Disease New DrugThe 15th Rare Disease Day: China's Policy & Market Overview China tries to make rare disease drugs available to more patients via measures like expediting the marketing approval of the drugs and reimbursing part of the medical expenses. Meanwhile, the rare disease treatment market is expanding rapidly.
Mar 04, 2022
Law & Regulation CDE Guideline Reference Listed Drug (RLD) Marketing Approval Clinical Trial Volume-Based Procurement Generic Drug Biosimilar New DrugMonthly Recap: China Pharmaceutical Regulatory Updates | January 2022 1. China Pilots Online Sales of Prescription Drugs in Shenzhen; 2. National Insulin Procurement to Start in May; 3. China NMPA Grants Two Rx-to-OTC Switches; 4. China NMPA Releases the 50th Batch of Reference Listed Drugs; 5. China NMPA Approves 221 Medical Devices; 6. China NMPA Issues Three Industry Standards for Medical Devices; 7. Pharmaceutical Guidelines.
Feb 10, 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
- 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