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.

Other Countries

Regarding the Provision of Information for the Proper Use of Over-the-Counter Drugs and Other Medicinal Products, and the Implementation of Adverse Reaction Reporting for Suspected Cases of Dependence (Request for Dissemination)

China

Measures for Cyberspace Security Supervision and Inspection by Public Security Organs

China

Notice of the General Affairs Department of the National Data Administration onIssuing the Guidelines for Data Property Rights Registration (Trial)

China

Medical Security Law of the People’s Republic of China

Other Countries, Pharma

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

China, Pharma

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

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)

China, Pharma

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

China, Pharma

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

Other Countries, Pharma

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

China, Pharma

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

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)

China, Pharma

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

China, Pharma

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

China, Pharma

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

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)

China, Pharma

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

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)

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)

China, Pharma

Implementation Measures for Drug Trial Data Protection (2026)

Pharm.east

Let’s make the point

Newsletter dedicated to Pharmaceutical Legal and Regulatory news on China and Far East Countries.