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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Introduces Revised Medical Devices Supervision and Administration Regulations
On January 7, 2025, China's National Medical Products Administration (NMPA) officially released the Medical Devices Supervision and Administration Regulations (Hereinafter referred to as the 2025 version), replacing the 2017 version.
Jan 22, 2025
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | December 2024
Check out the latest pharma regulatory updates in China: 1. China Releases Several Lists of Reference Listed Drugs (RLDs); 2. China NMPA Grants One Rx-to-OTC Switch; 3. China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP); 4. China Authorizes 5 Drugs for Inclusion in the CARE Plan...
Jan 22, 2025
POLICY
China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP)
China's National Joint Drug Procurement Office has unveiled the results of the 10th round of the Volume-Based Drug Procurement (VBP). The implementation of the selected drugs will commence in April 2025, with the specific start dates depending on provincial notifications.
Jan 22, 2025
REGULATION
China Issues Appendices to GMP for Pharmaceutical Excipients and Packaging Materials
On January 2, 2025, China's National Medical Products Administration (NMPA) released two appendices to the Good Manufacturing Practice for Pharmaceutical Products (2010 Revision), specifically targeting pharmaceutical excipients and packaging materials respectively. These appendices will come into effect on January 1, 2026. Before this date, manufacturers of pharmaceutical excipients and packaging materials must upgrade their facilities and enhance their quality management systems to fully comply with the new requirements.
Jan 03, 2025
REGULATION
Law & Regulation
Reference Listed Drug (RLD)
NRDL
Volume-based Procurement
Rare Disease
Drug Registration
China
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2024
Check out the latest pharma regulatory updates in China: 1. China CDE Solicits Public Comments on the 88th RLD Lists; 2. China Strengthens Oversight of Contract Drug Manufacturing; 3. China Standardizes Qualifications of and Requirements for Domestic Responsible Persons Designated by Overseas MAHs; 4. China Launches the 10th Round of Volume-Based Drug Procurement (VBP)
Dec 12, 2024
POLICY
China Launches the 10th Round of Volume-Based Drug Procurement (VBP)
On November 22, 2024, the China National Joint Drug Procurement Office launched the 10th round of volume-based procurement (VBP), involving 62 drugs. Eligible suppliers must provide basic information by 12:00 PM on December 2 and submit their application dossiers by 10:00 AM on December 12.
Nov 27, 2024
REGULATION
China Standardizes Requirements for Domestic Responsible Persons Designated by Overseas MAHs
On November 14, 2024, China's National Medical Products Administration (NMPA) issued the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAH) of Drugs.
Nov 19, 2024
Most Popular
- China Issues Appendices to GMP for Pharmaceutical Excipients and Packaging Materials
- Monthly Report: New Drug Approvals in China | December 2024
- China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP)
- Monthly Recap: China Pharmaceutical Regulatory Updates | December 2024
- China Introduces Revised Medical Devices Supervision and Administration Regulations
