The Shanghai Municipal Food and Drug Safety Commission issued a 15th Five-Year
Plan to ensure drug safety and promote high-quality pharmaceutical development,
outlining multiple regulatory reforms. It will deepen clinical-trial review and
approval reforms for innovative drugs and support R&D. The plan calls for
reforming review and approval procedures for supplemental applications for
domestic and overseas chemical drug production and offering front-end support
for major change filings on local chemical drugs. Shanghai will seek pilot
programs for dossier-based review of generics to accelerate first-to-market
generics, streamline post-approval change processes, pilot continuous
manufacturing technologies, and optimize temporary import procedures for
clinically urgent medicines.
