On August 26, 2019, the Drug Control Law of the People’s Republic of China (the “Law”) was revised at the Twelfth Meeting of the Standing Committee of the 13th National People’s Congress following three rounds of review and deliberation. The Law, as revised, will take effect on December 1, 2019. Generally speaking, the Law is a phased summary of the drug regulatory reforms following the issuance of “Circular 44” in 2015, such as the marketing authorization holder (MAH) system and drug review and approval system. The Law also lays a solid foundation for the future development of drug reforms. For example, the Law provides new provisions on online sales of prescription drugs and building a drug traceability system, among others.
