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Policy Interpretation of the Quality Management Specifications for Online Sales of Medical Devices
2025-07-21
With the rapid development of e-commerce, the online medical device sales market in China has experienced explosive growth in recent years. According to statistics, from 2018 to the present, the number of medical device distributors engaged in online sales has increased from 8,717 to over 360,000, while the number of third-party platform enterprises has grown from 77 to 851.
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Policy Interpretation of Provisions on the Experimental Research of Narcotic Drugs and Psychotropic Substances
2025-07-21
To strengthen the safety management of experimental research involving narcotic and psychotropic drugs, the Provisions propose requirements from multiple aspects, including safety management systems and facilities and equipment, entrusted research management, management of experimental researchers, and management of narcotic and psychotropic drugs and active substances.
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Announcement of the National Medical Products Administration (NMPA) on Matters Related to the Administration of the Inventory of Existing Cosmetic Ingredients (IECIC) (No. 61 of 2025)
2025-07-21
To implement the Regulations on Supervision and Administration of Cosmetics, further regulate the administration of cosmetic ingredients, and encourage innovation in raw materials, the following matters concerning the Inventory of Existing Cosmetic Ingredients (hereinafter referred to as the Inventory) are hereby announced.
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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.