On May 9, 2022, National Medical Products Administration (NMPA) issued for public comments a draft revision (the "Draft Revision") to the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (the "Regulations"). The public comment period ends on June 6, 2022.
The Regulations were last revised and became effective in March 2019. However, the Drug Administration Law of the PRC (the "Drug Administration Law") was substantially revised about six months later in August 2019, officially adopting the marketing authorization holder ("MAH") system that had been piloted for many years in certain provinces and cities. The revised Drug Administration Law has come into effect for more than two years, and the public is eagerly looking forward to the revision of the corresponding implementing regulations. Since the implementation of the MAH system, the NMPA and other authorities have formulated and updated numerous supplementary rules in addition to the Drug Administration Law. These rules are scattered in various separate regulations, notices, announcements, and guiding principles. Per its content, the Draft Revision would add a considerable number of provisions that have not been explained or clarified in the Drug Administration Law and also integrate the scattered rules and principles found in various normative documents of different levels.
