中国食品药品监管Issue(3)：42-47,6.DOI:10.3969/j.issn.1673-5390.2024.03.005
疫苗国家监管体系临床试验监管相关板块的评估与思考
Insights and Assessment on Clinical Trial Oversight Related Functions of National Regulatory Authority for Vaccines
杜娟 1高天睿 2崔孟珣 3蓝恭涛3
作者信息
- 1. 湖南省药品审评与不良反应监测中心
- 2. 国家药品监督管理局食品药品审核查验中心
- 3. 国家药品监督管理局
- 折叠
摘要
Abstract
On August 23,2022,the World Health Organization(WHO)announced that China had passed the assessment of National Regulatory Authority(NRA)for vaccines.The assessment indicators of the NRA for vaccines have significantly increased,with more comprehensive content and stricter standards.This article introduces the requirements of the WHO's Global Benchmarking Tool for clinical trial oversight related functions,and explores the changes and development of clinical trial oversight in recent years,aiming to offer reference for relevant entities to improve practice and oversight of clinical trials.关键词
疫苗国家监管体系/临床试验监管/质量管理体系Key words
national regulatory authority/clinical trials oversight/quality management system分类
医药卫生引用本文复制引用
杜娟,高天睿,崔孟珣,蓝恭涛..疫苗国家监管体系临床试验监管相关板块的评估与思考[J].中国食品药品监管,2024,(3):42-47,6.
