VTN PH-MD Deepening the Reform of Drug and Medical Device Regulation

This document, issued by the General Office of the State Council, delineates China’s strategic framework for reforming its pharmaceutical and medical device regulatory systems, with the aim of promoting high-quality development and fostering innovation.

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KOR MD-CS Deepening the Reform of Drug and Medical Device Regulation

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CHN CO-PH Deepening the Reform of Drug and Medical Device Regulation

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TLD CS-CO Deepening the Reform of Drug and Medical Device Regulation

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VTN CS-PH Deepening the Reform of Drug and Medical Device Regulation

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KOR CO-MD Deepening the Reform of Drug and Medical Device Regulation

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JPN CS Deepening the Reform of Drug and Medical Device Regulation

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CHN MD-PH Deepening the Reform of Drug and Medical Device Regulation

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Regulations

VTN PH-MD Deepening the Reform of Drug and Medical Device Regulation

KOR MD-CS Deepening the Reform of Drug and Medical Device Regulation

CHN CO-PH Deepening the Reform of Drug and Medical Device Regulation

TLD CS-CO Deepening the Reform of Drug and Medical Device Regulation

VTN CS-PH Deepening the Reform of Drug and Medical Device Regulation

KOR CO-MD Deepening the Reform of Drug and Medical Device Regulation

JPN CS Deepening the Reform of Drug and Medical Device Regulation

CHN MD-PH Deepening the Reform of Drug and Medical Device Regulation

Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (2025)

Foreign Investment Law of the People's Republic of China (2019)

Patent Law of the People's Republic of China (2020 Amendment)

Customs Law of the People's Republic of China (2021 Amendment)

Administrative Measures for the Import of Drugs (2012 Amendment)

Announcement for Market Regulation on Rewards for Internal Informants Reporting Issues Concerning the Quality and Safety of Medicinal Products and Medical Devices (2025)

Personal Information Protection Law of the People's Republic of China (2021)

Rules for the Classification of Medical Devices (2015)

Company Law of the People's Republic of China (2023)

Regarding the Study and Research on Drugs for the Purpose of Providing Information to Support Drug Registration and Approval- Thailand (2025)

Innovation in AI-based Medical Technologies for National Health Improvement - South Korea (2024)

The Department of Health establishes Preparatory Office for Hong Kong Centre for Medical Products Regulation (2024)

Anti-Monopoly Guidelines for the Pharmaceutical Sector by the State Council Anti-Monopoly and Anti-Unfair Competition Commission (2025)

Basic Principles Concerning Japanese Data in Cases Where Confirmatory Clinical Trials for Pharmaceuticals Used in Rare Diseases Have Been Conducted Exclusively Outside Japan (2024)

Data Security Law of the People's Republic of China (2021)

Technical Review Guidelines for Cybersecurity of Medical Devices - Second Edition (2020)

The General Office of the State Council's Opinions on Deepening the Reform of Drug and Medical Device Regulation and Promoting the High-Quality Development of the Pharmaceutical Industry (2024)

Draft for Opinions on Guidelines for the Determination of Medical Advertisements (2025)

Notice by the China National Medical Products Administration of Issuing the Pilot Work Plan for Optimizing the Review and Approval of Clinical Trials of Innovative Drugs (2024)

Administrative Provisions on Instructions for Use and Labels of Medical Devices (2014)

Notice on Issuing the Pilot Work Plan for Expanding in the Field of Wholly Foreign-owned Hospitals (2024)

Guidance on Therapeutic Product Registration in Singapore (2025)

Drug Administration Law of the People's Republic of China (2019 Revision)

Measures for the Drug Administration Registration (2020)

Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (2024 Revision)

Announcement of the National Medical Products Administration on Further Enhancing the Issuance of Drug Manufacturing Licenses (2025)

Announcement on Rewards for Internal Informants Reporting Issues Concerning the Quality and Safety of Medicinal Products and Medical Devices (2025)

Announcement of the National Medical Products Administration Regarding Matters Related to the Importation of Commercial-Scale Batches of Drugs Already Marketed Abroad Prior to Approval in China (2025)

Notice of the National Medical Insurance Administration and the National Health Commission on Issuing Several Measures to Support the High-Quality Development of Innovative Drugs (2025)

Announcement by the State Administration for Market Regulation on the Publication of the Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (2025)

The General Office of the State Council’s Notice on Printing and Distributing the Key Tasks for Deepening the Reform of the Medical and Health System in 2024

Announcement of the National Medical Products Administration and the National Intellectual Property Administration of Issuance of the Implementation Measures for the Mechanism for Early Settlement of Medicinal Product Patent Disputes (2021)

Announcement of the National Medical Products Administration on Issuing the Measures for the Administration of Medicinal Product Recalls (2022)

Notice by the National Healthcare Security Administration and the National Health Commission on Improving the Mechanism for Centralized Pharmaceutical Procurement and its Implementation (2024)

Provisional Regulation on the Administration of Designated Domestic Responsible Person by Overseas Drug Marketing Authorization Holders (2024)

Regulations on the Supervision and Administration of Medical Devices (2024 Revision)

Measures for the Supervision and Administration of Medical Device Production (2022)

Measures for the Administration of Registration and Recordation of Medical Devices (2021)

Announcement of the Center for Medical Device Evaluation of the National Medical Products Administration on Matters Concerning Further Enhancing Support for Innovative Medical Devices (2025)

Measures for the Administration of Inspection and Supervision of the Imported Medical Instruments (2007)

Announcement on Further Adjustments and Optimizations for the Production of Imported Medical Device Products by Domestic Enterprises in China (2025)

Regulation on the Supervision and Administration of Medical Devices (2024)

Measures for the Supervision and Administration of Production and Distribution of Cosmetics (2021)

Regulation on the Supervision and Administration of Cosmetics (2020)

Measures for the Administration of the Registration and Recordation of Cosmetics (2021)

Provisions for the Administration of Cosmetic Registration and Recordation (2021)

National Medical Products Administration Releases the 2024 Annual Report on National Cosmetic Sampling Inspection (2025)

Product Quality Law of the People's Republic of China (2018 Amendment)