国家药监局：“十五五”大力支持生物制造产业创新发展

Core Insights - The National Medical Products Administration (NMPA) is focusing on supporting the innovative development of the biomanufacturing industry during the 14th Five-Year Plan period, transitioning from "follow-up innovation" to "systematic innovation" and from "scale-speed growth" to "quality-efficiency growth" [1] - In 2025, China approved 76 innovative drugs, showcasing its leading position in global R&D applications, with a trend towards complex frontier technologies, diversified innovation entities, and internationalized regulatory standards [1] - The medical device sector is also experiencing strong innovation, with 76 innovative medical devices approved in 2025, a 17% year-on-year increase, and a significant rise in priority approvals [1] Industry Developments - In 2026, the NMPA plans to strengthen drug safety risk management by enhancing risk prevention mechanisms and regulatory oversight across the entire drug clinical trial chain [2] - The focus will be on encouraging innovation while managing risks, particularly in the development of urgently needed drugs and the implementation of drug trial data protection systems [2] - The NMPA aims to improve the quality and efficiency of generic drug evaluations and strengthen post-marketing management of generic drugs [2] Regulatory Enhancements - The NMPA will enhance supervision of online drug sales and improve the drug information traceability system to increase risk management efficiency [2] - Specific attention will be given to new drug targets, AI-driven drug development, and cell and gene therapies, with expedited approval channels to accelerate the market entry of new and effective drugs [2]