医药导报2026，Vol.45Issue(6)：1027-1034,8.DOI:10.3870/j.issn.1004-0781.2026.06.012
区域协同视角下优化我国药物临床试验监管工作的思考与探索
Reflection and Exploration on the Optimization of Drug Clinical Trial Supervision in China from the Perspective of Regional Coordination
李小芬 1孙搏 2张敏 1李明1
作者信息
- 1. 国家药品监督管理局药品审评检查长三角分中心,上海 201210
- 2. 上海药品审评核查中心,上海 201210
- 折叠
摘要
Abstract
To further improve the quality and regulatory effectiveness of drug clinical trials,this paper systematically re-views the landscape of China's drug registration clinical trial supervision,provides an in-depth analysis of the core regulatory phi-losophyof the United States and the European Union in drug clinical trial regulation,anddraws on their practical experience,and fromthe new perspective of regional coordinative development proposes feasible recommendations across four dimensions-regula-tory mechanisms,scope,inspectors,and tools,to establish a novel collaborative regulatory model.This will provide forward-loo-king theoretical references for refining China's regulatory model for drug clinical trials.关键词
注册核查/药物临床试验/监管科学/风险管理/药品注册Key words
Registration inspection/Drug elinical trial/Regulatory science/Risk management/Drug registration分类
医药卫生引用本文复制引用
李小芬,孙搏,张敏,李明..区域协同视角下优化我国药物临床试验监管工作的思考与探索[J].医药导报,2026,45(6):1027-1034,8.
