国家药监局：助力创新药“中国首发”

Core Insights - China is enhancing support for innovative drugs with new mechanisms and targets across the entire chain of communication, clinical trials, registration, and review processes to facilitate "China's first launch" of innovative drugs [1][2] - By 2025, there is an expectation for a significant increase in the market launch of urgently needed clinical products in the pharmaceutical and medical device sectors [1] Group 1: Pharmaceutical Sector - In 2022, the National Medical Products Administration (NMPA) approved a total of 4,087 drug registration applications, including 76 innovative drugs, marking a historical high [1] - The time gap for domestic and international drug listings has been reduced, with 59 foreign new drugs receiving temporary import approval [1] - A total of 138 children's drugs were approved, and 48 rare disease drugs were granted temporary import approval, addressing medication gaps for special populations [1] Group 2: Medical Device Sector - The NMPA approved 3,402 medical device products in 2022, including 76 innovative medical devices, achieving a new record [1] - The medical device innovation ecosystem is continuously improving, supporting industry upgrades [1][2] - In 2026, the NMPA plans to expedite the market launch of high-end medical devices and allocate more review resources to urgently needed innovative devices and those for rare disease prevention [2] Group 3: Future Initiatives - The NMPA will implement a drug trial data protection system and establish market exclusivity for children's and rare disease medications [2] - There will be a focus on optimizing the review and approval measures for cell and gene therapy drugs [2] - The establishment of a national standardized technical working group for intelligent frontier medical devices is planned to advance standard formulation in key areas such as brain-machine interfaces [2]