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.

China, Corporate

Opinions of the Supreme People’s Court on the Adjudication of Disputes Involving Artificial Intelligence in Accordance with the Law

China, Pharma

Notice of the National Healthcare Security Administration on Piloting a System for the Preliminary Establishment of Medical Service Pricing Items for Advanced New Technologies and Products

Pharma, China

Announcement of the National Medical Products Administration on Further Strengthening Digital Drug Traceability Management

China, Pharma

Announcement of the National Medical Products Administration and the General Administration of Customs on Matters Concerning the Pilot Implementation of Electronic Customs Clearance for Imported Medicinal Products at Beijing Ports

China, Corporate

Implementing Opinions of the Ministry of Commerce and Seven Other Departments on Accelerating the Development of AI Plus Consumption

China, Medical Devices

Notice of the National Medical Products Administration on Issuing the Inspection Guidelines for Good Manufacturing Practice for Medical Devices

China, Pharma

Notice of the Ministry of Industry and Information Technology and Nine Other Departments on Issuing the 15th Five-Year Plan for the development of the Pharmaceutical Industry

China, Corporate

Interim Measures for the Administration of Anthropomorphic AI Interactive Services

China, Pharma

“Xianrui Plan” for Cell and Gene Therapy Medicinal Products (Draft for Comments)

China, Pharma

NMPA Conducts Management Review of the Quality Management Systems for Vaccine Regulatory Oversight and Drug GMP Compliance Supervision

China, Corporate

Provisions of the State Council on Outbound Investment

China, Pharma

Notice on Further Improving Policy Interpretation for the Alignment and Implementation of the Guidelines for the Establishment of Medical Service Pricing Items

China, Pharma

Notice on Ensuring the Priority Provision and Use of Essential Medicines

China, Pharma

Administrative Provisions on Changes to the Registered Entities of Chemical Active Pharmaceutical Ingredients (Draft for Comments)

China, Medical Devices, Pharma

Notice of the National Healthcare Security Administration on Issuing the 15th Five-Year Plan for Universal Healthcare Security

China, Corporate

Measures for the Administration of Priority Examination of Patents

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

Pharm.east

Let’s make the point

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