-
NMPA holds meeting to review QMS in vaccine regulation, pharmaceutical manufacturing inspection
The National Medical Products Administration (NMPA) held a meeting on June 9 to conduct the 2024 annual review of the quality management system (QMS) in vaccine regulation and pharmaceutical manufacturing inspection.
-
NMPA Announcement on Further Improvement and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025)
To thoroughly implement the decisions of the CPC Central Committee and the State Council on advancing high-level opening-up, fully carry out the requirements of the Opinions of the General Office of the State Council on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry (GBF [2024] No. 53), continuously deepen the reform of medical device regulation, and promote the high-quality development of the medical device industry, the following adjustments and optimizations are hereby made to certain provisions of the Announcement.
-
NPMA Announcement on Expanding the Implementation Scope of Electronic Common Technical Documents (No.10, 2025)
To accelerate the implementation process of the Electronic Common Technical Document (eCTD) in China and enhance the service capabilities of "Internet + Drug Regulation" applications, the following matters concerning the expansion of the eCTD implementation scope are hereby announced.
- NMPA Announcement on Further Improvement and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025)
- NPMA Announcement on Expanding the Implementation Scope of Electronic Common Technical Documents (No.10, 2025)
- Announcement of the National Medical Products Administration and National Health Commission on Issuing the 2025 Edition of the Pharmacopoeia of the People’s Republic of China (No. 29, 2025)