上半年创新药和医疗器械获批数量同比大幅增长

Core Insights - In the first half of this year, China approved 43 innovative drugs and 45 innovative medical devices, representing year-on-year increases of 59% and 87% respectively, indicating that reform policy dividends are transforming into industrial development momentum [1] Regulatory Reforms - Since last year, the National Medical Products Administration (NMPA) has conducted pilot reforms in 11 provincial-level bureaus to optimize the supplementary application process for drugs, reducing the review time for supplementary applications that require inspection from 200 working days to 60 working days [1] - The NMPA is also exploring the completion of clinical trial reviews and approvals for key innovative drugs within 30 working days [1] Product Approvals - In the first half of the year, 70 new pediatric drugs and 21 rare disease drugs were approved [1] Innovation Initiatives - The Ministry of Industry and Information Technology and the NMPA jointly launched an initiative to promote innovation in artificial intelligence medical devices and biomedical materials [1] - The NMPA introduced 10 measures to optimize the full lifecycle supervision to support the innovative development of high-end medical devices, facilitating the market entry of complex and high-difficulty innovative medical devices such as multifocal intraocular lenses and cardiac pulsed field ablation devices [1]