Regulations

The Regulations section of Health Law Asia offers curated translations of pharmaceutical, medical device, and cosmetics regulations across China and the Far East.

Our legal team provides commentary on new laws and regulations, NMPA guidelines, CSAR updates, and ASEAN regulatory harmonization, helping companies and institutions stay compliant with evolving healthcare standards.

Stay informed with practical updates designed for compliance officers, regulatory professionals, and legal departments operating in Asia’s most dynamic healthcare markets.

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.

See attachment

KOR MD-CS 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.

See attachment

CHN CO-PH 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.

See attachment

TLD CS-CO 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.

See attachment

VTN CS-PH 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.

See attachment

KOR CO-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.

See attachment

JPN CS 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.

See attachment

CHN MD-PH 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.

See attachment

Pharma, Other Countries

Regulatory Guidance on GCP compliance inspection framework - Singapore (2026)

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China, Pharma

Notice of the General Office of the National Health Commission on Strengthening the Administration of Continuous Medication for Residents (2026)

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China, Pharma

Notice of the General Office of the National Health Commission on Launching the Action Plan for Promoting Rational Medication Use among Older Adults (2026–2030)

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China, Pharma

Notice of the State Council on Issuing the National Health Plan for the 15th Five-Year Plan Period (2026)

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China, Pharma

Technical Guideline on the Scope and Classification of Gene Therapy Medicinal Products (2026 Edition)

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Pharma, Other Countries

Notification of the Procedures for Submission of Applications and GDP Inspection for the Year 2026 - Thailand (2025)

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China, Pharma

Announcement of the 12th National Centralized Volume-Based Procurement of Pharmaceuticals (2026)

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China, Pharma

Announcement of the National Medical Products Administration on Matters Concerning the Application of the Priority Review and Approval Procedures for Drug Marketing Authorization of Chemical Active Pharmaceutical Ingredients (2026)

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China, Pharma

Interpretation of Announcement on 2026 Medical Insurance Drug Catalog Preliminary Review Results

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China, Pharma

Procedures for the Review and Approval of Applications for Conditional Marketing Authorization of Pharmaceutical Products (2026)

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China, Pharma

Guiding Principles for the Development of Appropriate Pharmaceutical Packaging Specifications (2026)

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China, Corporate

Guiding Opinions of the General Office of the State Council on Strengthening Supervision, Preventing Risks, and Promoting the High-Quality Development of Private Investment Funds (2026)

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China, Pharma

Announcement of the National Medical Products Administration on Issuing the Good Clinical Practice for Drug Trials (2026)

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China, Pharma

Notice of the General Affairs Department of the National Medical Products Administration on Ensuring the Proper Implementation of Work Related to the Segmented Manufacturing of Biological Products (2026)

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China, Pharma

Notice of the General Office of the National Medical Products Administration on Issuing the Compliance Guidelines for the Online Retail Sale of Prescription Drugs (2026)

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China, Pharma

Implementation Measures for Drug Trial Data Protection (2026)

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Pharma, Other Countries

Policy on the Handling of Pharmaceutical Patents in Relation to the Approval Review under the Pharmaceuticals and Medical Devices Act and the National Health Insurance Price Listing of Medical-use Generic Drugs and Biosimilars - Japan (2025)

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China, Pharma

Measures for the Administration of Medical Representatives (2026)

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China, Pharma

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

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China, Pharma

The Supreme People's Procuratorate Releases Six Typical Cases on Deepening the Public Interest Litigation for Food and Drug Safety Procuratorial Supervision

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Pharma, Other Countries

Regulations Regarding Clinical Drug - Vietnam (2025)

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China, Pharma

Announcement of the National Medical Products Administration on Strengthening the Supervision and Administration of Entrusted Drug Manufacturing (2025)

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China, Pharma

Several Opinions of the General Office of the State Council on Improving the Drug Price Formation Mechanism (2026)

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China, Pharma

Guiding Opinions on the Standardized Development of Modern Pharmaceutical Logistics (2026)

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China, Pharma

Regulations for Work Procedures and Technical Requirements for Drug Registration Testing (2025 Revision)

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China, Pharma

Implementation Opinions of the National Medical Products Administration on Promoting the Integration of Artificial Intelligence into Drug Regulation (2026)

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China, Pharma

"Primary evaluation" begins phased implementation and applications of new drugs for registration accepted under initial phase - Hong Kong (2026)

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China, Corporate

Anti-Monopoly Law of the People's Republic of China (2022 Amendment)

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China, Pharma

Announcement of NMPA on Further Optimizing the Review and Approval of Clinically Urgently Needed Overseas Marketed Drugs (2026)

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Pharma, Other Countries

Comprehensive Lifecycle Collaboration Plan for the Promotion of Pharmaceutical and Biotechnology Ventures - South Korea (2026)

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China, Corporate

Cybersecurity Law of the People's Republic of China (2025 Amendment)

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China, Corporate

Foreign Trade Law of the People's Republic of China (2025 Revision)

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Pharma, Other Countries

Circular on Prescribing Marketing Authorization of Drugs and Medicinal Materials - Vietnam (2025)

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China, Corporate

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

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China, Pharma

Procedures for Handling Filing-based Post-approval Changes for Drugs Manufactured Outside China (2026)

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China, Pharma

Measures for the Supervision of Drug Quality Sampling and Testing (Draft for Public Comment)

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China, Corporate

Trademark Law of the People's Republic of China (2019 Amendment)

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China, Pharma

Regulations on Inspection of Exported Drugs and Management of Export Certificates for Pharmaceutical Manufacturers (2025)

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China, Pharma

Notice of the Shanghai Municipal Medical Products Administration on Issuing the Guiding Opinions on Modern Drug Logistics in Shanghai

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China, Pharma

Draft for Opinions on Regulations on the Quality Management of Drug Clinical Trials (2025)

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China, Pharma

Case of an Antimonopoly Administrative Penalty Involving a Horizontal Monopolistic Agreement on the API Camphor (2025)

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China, Pharma

Notice on Issuing the Key Tasks for Correcting Unhealthy Practices in the Field of Pharmaceutical Procurement and Medical Services in 2025

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Other Countries

Early Consideration on Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original Biopharmaceuticals (2025)

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China, Corporate

Notice by the General Office of the State Council Regarding Implementing the Standards for Domestic Products and Relevant Policies in Government Procurement (2025)

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China, Pharma

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

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China, Corporate

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

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China, Corporate

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

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China, Corporate

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

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China, Pharma

Administrative Measures for the Import of Drugs (2012 Amendment)

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China, Medical Devices, Pharma

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

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China, Corporate

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

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China, Medical Devices

Rules for the Classification of Medical Devices (2015)

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China, Corporate

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

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Other Countries

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

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Other Countries

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

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China, Pharma

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

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China, Corporate

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

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Other Countries

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

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China, Corporate

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

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China, Medical Devices

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

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China, Medical Devices, Pharma

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)

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China, Pharma

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)

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China, Medical Devices

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

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China

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

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Other Countries

Guidance on Therapeutic Product Registration in Singapore (2025)

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China, Pharma

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

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China, Pharma

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

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China, Pharma

Measures for the Drug Administration Registration (2020)

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China, Pharma

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

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China, Pharma

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

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China, Pharma

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)

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China, Pharma

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)

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China, Corporate

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

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China, Pharma

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

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China, Pharma

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

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China, Pharma

Announcement of the National Medical Products Administration and the National Intellectual Property Administration on Issuing the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (2021)

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China, Pharma

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

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China, Pharma

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

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China, Medical Devices

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

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China, Medical Devices

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

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China, Medical Devices

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

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China, Medical Devices

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

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China, Medical Devices

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)

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China, Medical Devices

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

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China, Medical Devices

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

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China, Cosmetics

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

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China, Cosmetics

Regulation on the Supervision and Administration of Cosmetics (2020)

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China, Cosmetics

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

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China, Cosmetics

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

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China, Cosmetics

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

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China, Cosmetics

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

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