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Apr 27,2020
Express n° 9 News: PT | No inkling of Patent Linkage System in China’s New PROVISIONS FOR DRUG REGISTRATION
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