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
维普
万方数据