中国食品药品监管Issue(2)：136-141,6.DOI:10.3969/j.issn.1673-5390.2025.02.014
基于风险防控的药物临床试验机构监督检查关注点分析
Risk Based Analysis of Supervision and Inspection Concerns in Drug Clinical Trial Institutions
王健 1冯巧巧 1李超 1张建永 1申洪泮1
作者信息
摘要
Abstract
Objective:This article aims to analyze the key concerns in the supervision and inspection of drug clinical trial institutions,propose risk prevention and control measures,and provide technical support for scientific drug regulation.Methods:In regulatory practice,the Measures for Supervision and Inspection of Drug Clinical Trial Institutions(Trial)and the Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions(Trial)were applied.Based on these,the supervision and inspection concerns were sorted and analyzed,relevant risk points identified,risk warnings clarified,and control measures proposed.Results and Conclusion:Risk-based supervision and inspection of drug clinical trial institutions is an important means of scientific drug regulation.It plays a positive role in improving inspection efficiency,utilizing regulatory resources more effectively,and enhancing the level of drug clinical research.关键词
药物临床试验机构/监督检查/风险防控/备案管理/主要研究者Key words
drug clinical trial institutions/supervision and inspection/risk prevention and control/filing management/principal investigator分类
医药卫生引用本文复制引用
王健,冯巧巧,李超,张建永,申洪泮..基于风险防控的药物临床试验机构监督检查关注点分析[J].中国食品药品监管,2025,(2):136-141,6.
