中国食品药品监管Issue(6)：56-71,16.DOI:10.3969/j.issn.1673-5390.2026.06.006
美国FDA药品审评报告模板的演变对审评决策体系建设的启示
Implications of the Evolution of FDA Drug Review Report Templates for the Development of Drug Review Decision-Making Systems
摘要
Abstract
Review report templates serve as an important vehicle linking regulatory decision-making and public trust.Using the data-information-knowledge-wisdom(DIKW)model,this paper reviews and analyzes the evolution of drug review report templates used by the U.S.Food and Drug Administration(FDA),from discipline-specific review report templates to multidisciplinary review report templates,and ultimately to integrated review report templates centered on key scientific issues.The paper further explores the application of artificial intelligence(AI)tools in drug review,with the aim of providing insights for advancing drug review practices in China.关键词
药品审评/透明度/审评报告模板/人工智能/监管科学Key words
drug review/transparency/review report templates/artificial intelligence/regulatory science分类
医药卫生引用本文复制引用
周燕燕,林妍,谭娟,陈晓媛,杨劲..美国FDA药品审评报告模板的演变对审评决策体系建设的启示[J].中国食品药品监管,2026,(6):56-71,16.基金项目
中国药品监督管理研究会课题(2023-Y-Y-008) （2023-Y-Y-008）
中国食品药品国际交流中心委托课题(2024200923、20252002125) （2024200923、20252002125）
