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
Announcement of the National Medical Products Administration on Strengthening the Supervision and Administration of Entrusted Drug Manufacturing (2025)
China, Pharma
Several Opinions of the General Office of the State Council on Improving the Drug Price Formation Mechanism (2026)
China, Pharma
Guiding Opinions on the Standardized Development of Modern Pharmaceutical Logistics (2026)
China, Pharma
Regulations for Work Procedures and Technical Requirements for Drug Registration Testing (2025 Revision)
China, Pharma
Implementation Opinions of the National Medical Products Administration on Promoting the Integration of Artificial Intelligence into Drug Regulation (2026)
China, Pharma
“Primary evaluation” begins phased implementation and applications of new drugs for registration accepted under initial phase – Hong Kong (2026)
China, Corporate
Anti-Monopoly Law of the People’s Republic of China (2022 Amendment)
China, Pharma
Announcement of NMPA on Further Optimizing the Review and Approval of Clinically Urgently Needed Overseas Marketed Drugs (2026)
Other Countries, Pharma
Comprehensive Lifecycle Collaboration Plan for the Promotion of Pharmaceutical and Biotechnology Ventures – South Korea (2026)
China, Corporate
Cybersecurity Law of the People’s Republic of China (2025 Amendment)
China, Corporate
Foreign Trade Law of the People’s Republic of China (2025 Revision)
Other Countries, Pharma
Circular on Prescribing Marketing Authorization of Drugs and Medicinal Materials – Vietnam (2025)
China, Corporate
Labor Law of the People’s Republic of China (2018 Amendment)
China, Pharma
Procedures for Handling Filing-based Post-approval Changes for Drugs Manufactured Outside China (2026)
China, Pharma
Measures for the Supervision of Drug Quality Sampling and Testing (Draft for Public Comment)
China, Corporate
Trademark Law of the People’s Republic of China (2019 Amendment)
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)
Pharm.east
Let’s make the point
Newsletter dedicated to Pharmaceutical Legal and Regulatory news on China and Far East Countries.