中国食品药品监管Issue(2)：44-49,6.DOI:10.3969/j.issn.1673-5390.2025.02.004
研究者视角:优化临床试验审评审批机制的机遇与挑战
Investigator Perspectives:Opportunities and Challenges in Optimizing the Clinical Trial Application Review and Approval Mechanism
摘要
Abstract
In July 2024,the National Medical Products Administration(NMPA)launched a pilot program to optimize the clinical trial review and approval process for innovative drugs,significantly shortening the approval timeline for Category 1 drug applications and improving R&D efficiency.This paper,from the investigator perspective,analyzes domestic and international clinical trial review and approval systems,evaluates the implementation of pilot program,and explores its opportunities and challenges for clinical research institutions,ethics committees,and investigators.The pilot program requires these stakeholders to assume greater responsibilities in innovative drug development,necessitating stronger collaboration between institutions and ethics committees,optimize risk management mechanisms,and a more central role for investigators in early-phase clinical trials.A multi-party,coordinated approach will be key to ensuring scientific,standardized,and efficient implementation of the pilot program and clinical trials,ultimately supporting the internationalization of China's drug regulatory framework and accelerating innovative drug development.关键词
优化审评审批/研究者视角/风险管理/创新药/临床试验Key words
optimized review and approval/investigator perspective/risk management/innovative drugs/clinical trials分类
医药卫生引用本文复制引用
严钰茸,曹钰然,曹国英,武晓捷,何金杰,张菁..研究者视角:优化临床试验审评审批机制的机遇与挑战[J].中国食品药品监管,2025,(2):44-49,6.基金项目
科技部"重大新药创制"科技重大专项(2017ZX09304005) （2017ZX09304005）
