On March 30, 2020, China’s State Administration for Market Regulation issued the revised Provisions for Drug Registration ("the Provisions"), which will become effective as of July 1, 2020. The Provisions makes procedural and substantive changes to the 2007 version, highlighting the importance of administrative management of drug registration, encouraging innovation of both innovative drugs and generics, and creating new mode for the classification of innovative drugs and diversified routes for drug marketing authorization. The Provisions also introduces a system of drug correlated assessment and approval for its chemical ingredients and the like, and a liability regime of drug marketing authorization holder.

The Provisions relaxes some requirements: status of others’ patent and the applicant’s non-infringement statement for drug registration are excluded from the submission. The Provisions is silent on a patent linkage system of drugs, which has been proposed in the Draft Provisions and the Sino-US Economic and Trade agreement signed earlier this year, though the Supreme People's Court’s legislative plan for Judicial Interpretations of the year does include the “Provisions on Several Issues Concerning Application of Law in the Adjudication of Drug Patent Linkage Dispute”.

Contributed by: Yue Guan