建立儿童药品市场独占期制度

Core Insights - China is enhancing support for innovative drugs with new mechanisms and targets throughout the entire process from communication, clinical trials, registration, to review and approval, aiming to facilitate "China's first launch" of innovative drugs [1][2] Group 1: Regulatory Developments - The National Medical Products Administration (NMPA) approved a record 4,087 drug registration applications in 2022, including 76 innovative drugs, marking a historical high [2] - The time gap for domestic and international drug listings has been further reduced, with 59 foreign new drugs receiving temporary import approval [2] - A priority review and approval mechanism for pediatric drugs has been continuously promoted, resulting in the approval of 138 pediatric drugs in 2022 [2] Group 2: Focus on Rare Diseases - The temporary import channel for rare disease drugs remains open, with 48 rare disease drugs approved in 2022, effectively filling the medication gap for special populations [2] Group 3: Internationalization of the Pharmaceutical Industry - The internationalization of the pharmaceutical industry is accelerating, with cumulative overseas licensing transactions for innovative drugs exceeding $130 billion, indicating China's transition towards becoming a major exporter of innovative drugs [2] Group 4: Future Initiatives - In 2026, the NMPA plans to implement targeted measures, including the establishment of a drug trial data protection system and a market exclusivity system for pediatric and rare disease drugs [2] - The NMPA will strengthen service support for new mechanism and target innovative drugs across the entire chain, and pilot pre-application services for new generic drugs in selected regions to enhance application quality [2]