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, Pharma
Regulations on Inspection of Exported Drugs and Management of Export Certificates for Pharmaceutical Manufacturers (2025)
China, Pharma
Notice of the Shanghai Municipal Medical Products Administration on Issuing the Guiding Opinions on Modern Drug Logistics in Shanghai
China, Pharma
Draft for Opinions on Regulations on the Quality Management of Drug Clinical Trials (2025)
China, Pharma
Case of an Antimonopoly Administrative Penalty Involving a Horizontal Monopolistic Agreement on the API Camphor (2025)
China, Pharma
Notice on Issuing the Key Tasks for Correcting Unhealthy Practices in the Field of Pharmaceutical Procurement and Medical Services in 2025
Other Countries
Early Consideration on Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original Biopharmaceuticals (2025)
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)
China, Pharma
Regulations on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (2025)
China, Corporate
Foreign Investment Law of the People’s Republic of China (2019)
China, Corporate
Patent Law of the People’s Republic of China (2020 Amendment)
China, Corporate
Customs Law of the People’s Republic of China (2021 Amendment)
China, Pharma
Administrative Measures for the Import of Drugs (2012 Amendment)
China, Medical Devices, Pharma
Announcement of the National Medical Products Administration, Ministry of Finance, and State Administration for Market Regulation on Rewards for Internal Informants Reporting Issues Concerning the Quality and Safety of Medicinal Products and Medical Devices (2025)
China, Corporate
Personal Information Protection Law of the People’s Republic of China (2021)
China, Medical Devices
Rules for the Classification of Medical Devices (2015)
China, Corporate
Company Law of the People’s Republic of China (2023)
Other Countries
Regarding the Study and Research on Drugs for the Purpose of Providing Information to Support Drug Registration and Approval- Thailand (2025)
Other Countries
Innovation in AI-based Medical Technologies for National Health Improvement – South Korea (2024)
China, Pharma
The Department of Health establishes Preparatory Office for Hong Kong Centre for Medical Products Regulation (2024)
China, Corporate
Anti-Monopoly Guidelines for the Pharmaceutical Sector by the State Council Anti-Monopoly and Anti-Unfair Competition Commission (2025)
Pharm.east
Let’s make the point
Newsletter dedicated to Pharmaceutical Legal and Regulatory news on China and Far East Countries.