支持创新药和医疗器械发展，激发研发活力呵护百姓健康

Core Insights - China has transitioned from being a low-cost supplier of raw materials in the global pharmaceutical industry to becoming a significant source of drug innovation [1][2] - The "14th Five-Year Plan" emphasizes support for the development of innovative drugs and medical devices, indicating a robust growth trajectory for China's pharmaceutical industry [1] - Recent reforms in drug review and approval processes have accelerated the innovation and market entry of new drugs, with average review times significantly reduced [1][2] Group 1: Drug Innovation and Approval - The National Medical Products Administration (NMPA) has established expedited pathways for innovative drugs, including breakthrough therapy designations and priority reviews, resulting in an average review time of 225 working days for innovative drug applications in 2024 [1] - The average review time for priority-reviewed innovative drugs is only 162 working days, showcasing a marked improvement in approval speed [1] - The NMPA's support for clinical value-oriented drug innovation is evident through the establishment of various fast-track approval channels [1] Group 2: Medical Device Innovation - In November, the NMPA approved three innovative medical devices, reflecting a commitment to enhancing the regulatory framework for high-end medical devices [2] - The NMPA's 2025 announcement outlines ten measures to support the innovation of high-end medical devices, including optimizing special approval processes and improving standard systems [2] - China's drug review technical requirements are now fully aligned with international standards, allowing for synchronized drug submissions both domestically and internationally [2] Group 3: Market Dynamics and International Collaboration - The Chinese pharmaceutical market has grown to become the second largest in the world, attracting increased investment and interest from foreign pharmaceutical companies [3] - Despite the growth, there is a noted lack of original innovative drugs with new targets and mechanisms, indicating a need for enhanced foundational research and core technology development [3] - The NMPA emphasizes the importance of a collaborative approach among various sectors to boost original innovation capabilities in the biopharmaceutical industry [3]