支持创新药和医疗器械发展 激发研发活力呵护百姓健康

Group 1: Industry Transformation - China has transitioned from being viewed as a low-cost supplier of raw materials in the global pharmaceutical industry to becoming a significant source of drug innovation [1] - 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 with enhanced innovation and global competitiveness [1] - The National Medical Products Administration (NMPA) has implemented reforms to accelerate drug review and approval processes, establishing mechanisms to expedite the market entry of innovative drugs [1] Group 2: Regulatory Support and Innovation - The NMPA has introduced four expedited pathways for drug approval, including breakthrough therapy designation and priority review, significantly reducing the average review time for innovative drugs [1] - In 2024, the average review time for innovative drug applications is projected to be 225 working days, with priority-reviewed drugs taking only 162 working days [1] - Recent approvals of innovative medical devices, such as single-use pressure monitoring catheters and aortic stent systems, reflect the NMPA's commitment to supporting high-end medical device innovation [2] Group 3: Global Market Engagement - China's pharmaceutical industry has become the second-largest market globally, attracting increased investment and interest from foreign pharmaceutical companies [3] - The country is now participating in the global launch of new drugs, with examples like the global first launch of certain monoclonal antibodies in China, allowing local patients to access the latest treatments sooner [2] - Despite progress, there is a recognition of the need for more original innovative drugs and foundational research in the life sciences to enhance China's source innovation capabilities [3]