疫苗国家监管体系评估临床试验监管板块要求及对监管工作的启示  

Insights and Suggestions on Assessment of Clinical Trial Oversight Function of National Regulatory System for Vaccines

作　　者：殷霄 苏瑶 陈维 高晨燕[1] 王海学[1] YIN Xiao;SU Yao;CHEN Wei;GAO Chen-yan;WANG Hai-xue(Center for Drug Evaluation,National Medical Products Administration)

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》2023年第5期8-17,共10页China Food & Drug Administration Magazine

摘　　要：疫苗国家监管体系(NRA)评估是疫苗预认证工作的重要组成部分,是对国家监管能力评估的关键手段。我国疫苗监管体系于2022年第三次通过世界卫生组织(WHO)评估,达到3级成熟度水平。本文主要介绍了NRA评估内容及在评估中使用的全球基准评估工具,重点阐述其中临床试验监管(CT)板块的指标设置和评价要求等,并结合第三次NRA评估情况简述近年来我国临床试验监管工作的开展和完善情况,此外,还根据CT板块评估要求进一步分析了目前临床试验监管方面尚待改进的问题。The WHO's assessment of the national regulatory system for vaccines is an important part of vaccine prequalification and a key means of assessing national regulatory capacity.China's vaccine regulatory system reached level 3 maturity in the third WHO assessment in 2022.This article introduces the content of NRA assessment and the benchmarking tools used in the evaluation,focusing on the indicator setting and assessment requirements of the clinical trial oversight functions.It also describes the development and improvement of China's clinical trial regulatory system in recent years based on the third NRA evaluation,and further analyzes the issues that still need improvement in clinical trial supervision according to the requirements of the clinical trial oversight functions.

关 键 词：疫苗 国家监管体系评估 全球基准评估工具 临床试验监管 

分 类 号：R95[医药卫生—药学]