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NMPA CDE Announcement on Issuing the Technical Guideline for Safety Information Assessment and Reporting in Pediatric Drug Clinical Trials (Interim) ([2025] No. 21)
2025-09-05
In order to standardize the risk monitoring, identification, assessment, and control of safety information in pediatric drug clinical trials, the CDE, under the deployment of the NMPA, has organized the formulation of the Technical Guideline for Safety Information Assessment and Reporting in Pediatric Drug Clinical Trials (Interim).
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Support Anti-Tumor Drug R&D for Kids — SPARK Plan
2025-09-05
The "Support Anti-Tumor Drug R&D for Kids (SPARK Plan)" is a pilot work launched by the CDE to implement the NMPA's principles of "early engagement, tailored guidance, full-process support, and coordinated review". Building upon the "Patient-Centered Action for Rare Diseases Encouragement (CARE Plan)", the SPARK Plan is carried out in the field of pediatric drug development.
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NMPA Announcement on Further Improvement and Optimization of Matters Concerning the Production of Imported Medical Devices in Domestic Enterprises in China (No. 30, 2025)
2025-06-11
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.
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NPMA Announcement on Expanding the Implementation Scope of Electronic Common Technical Documents (No.10, 2025)
2025-06-11
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.
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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)
2025-06-11
According to the Drug Administration Law of the People's Republic of China, the Pharmacopoeia of the People's Republic of China (2025 Edition) (hereinafter referred to as Chinese Pharmacopoeia) has been reviewed and approved by the Plenary Meeting of the Executive Committee of the 12th Chinese Pharmacopoeia Commission.
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NMPA Announcement on Matters Related to the Implementation of the 2025 Edition of the Pharmacopoeia of the People's Republic of China (No. 32, 2025)
2025-06-11
The 2025 Edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the Chinese Pharmacopoeia) has been issued by Announcement No. 29, 2025 of the National Medical Products Administration and the National Health Commission and shall come into force as of October 01, 2025.