Authored by:Huang Ling, Huang Jianwen, Wang Xinghua (Owen), Xu Jiaxing (Jason), Liu Ning and Fang wei
The Implementation Regulations of the Drug Administration Law (the “Regulations”) are a key set of supporting administrative rules for the PRC Drug Administration Law. The current Regulations were promulgated in 2002 and have only undergone three technical amendments (in 2016, 2019 and 2024). On 16 January 2026, Premier Li Qiang signed a State Council Decree promulgating the revised Implementation Regulations of the Drug Administration Law of the PRC (the “New Regulations”). The New Regulations comprise nine chapters and 89 articles (including general principles, drug R&D and registration, marketing authorization holders, manufacturing, distribution, medical institution drug management, supervision, legal liability and supplementary provisions) and will take effect on 15 May 2026. This is the first comprehensive revision in over two decades, with more than 90% of the provisions amended.