创新药加速上市，质量如何保障？人民日报调查

Core Viewpoint - The rapid approval of innovative drugs in China has raised questions about how to ensure their quality and safety, with the National Medical Products Administration (NMPA) implementing strict regulations and quality management throughout the drug development and approval process [1][5][8]. Group 1: Innovative Drug Approval - During the "14th Five-Year Plan" period, China approved 210 innovative drugs, with 56 approved in the first eight months of this year, surpassing the total of 48 from the previous year, indicating a rapid growth trend [1][2]. - The NMPA has established four accelerated pathways for innovative drugs, including breakthrough therapy designation and conditional approval, to streamline the approval process from research to market [2][7]. Group 2: Quality Management in Drug Development - The NMPA has set strict regulations for new drug development, requiring confirmation of chemical structures, animal testing, and rigorous clinical trials to ensure safety and efficacy before market release [5][8]. - Companies like Shanghai Junshi Biosciences have successfully launched multiple innovative drugs, focusing on unmet clinical needs and maintaining a robust research and development team to ensure quality [6]. Group 3: Post-Market Surveillance - Continuous post-market surveillance is crucial for maintaining drug quality and safety, with the NMPA requiring drug holders to establish comprehensive quality assurance systems and conduct thorough reviews of production processes [8][9]. - The NMPA has implemented a risk monitoring system for newly launched drugs, enhancing the ability to detect and respond to safety risks promptly [9].