临床试验期间药物警戒与风险监管制度及体系建设工作进展  

Progress of Pharmacovigilance and Risk Management System During Drug Clinical Trials

作　　者：裴小静[1] 王海学[1] 王涛[1] 

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2021年第1期72-78,共7页China Food & Drug Administration Magazine

摘　　要：药物警戒是临床试验期间风险管理的主要工作内容之一。中国自加入国际人用药品注册技术协调会(ICH)后,开始加快建立和完善临床试验期间的药物警戒工作,包括制订相关法律法规、建立药物警戒系统,为临床试验期间的药物警戒工作奠定了良好基础。本文从药物警戒工作的起源和法律法规的发展,以及风险管控的技术标准体系等方面详细讨论了临床试验期间安全风险的监测、分析、评估和控制,阐述了相关工作实施进展以及对未来安全风险监管工作的思考。Pharmacovigilance is a key part of risk management during drug clinical trials.Since joining the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH),China has been working to improve pharmacovigilance during drug clinical trials,including developing laws and regulations and setting up the electronic system for pharmacovigilance.This paper looks at the origin and development of laws and regulations on pharmacovigilance,and discusses risk monitoring,assessment and control by examining the technical standard system for risk control.This paper also provides an update on the progress of pharmacovigilance activities and offers perspectives on future risk management during drug clinical trials in China.

关 键 词：药物临床试验 药物警戒 风险监管 制度和体系建设 进展 

分 类 号：R951[医药卫生—药学]