At a May 28 regular press briefing, the Ministry of Natural Resources published
and explained the Guiding Opinions on Accelerating High-Quality Development of
Marine Drugs and Functional Products. On intellectual property protection, Yu
Jiangyong, deputy director of the Drugs Registration Management Department at
the National Medical Products Administration (NMPA), said the NMPA and the China
National Intellectual Property Administration (CNIPA) have established an
early-resolution mechanism for drug patent disputes. The newly revised
Implementing Regulations of the PRC Drug Administration Law (the Regulations)
further strengthen protection for drug trial data and establish a market
exclusivity-period system for pediatric medicines and drugs for rare diseases.
The Measures for the Protection of Drug Trial Data took effect simultaneously
with the Regulations on May 15, and the Regulations’ specific implementation
documents for the market exclusivity system are currently being intensively
drafted. NMPA said these measures will further bolster IP protection for
innovative drugs and stimulate firms’ innovation momentum in marine drug R&D.
