Insights and Assessment on Clinical Trial Oversight Related Functions of National Regulatory Authority for Vaccines
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.
national regulatory authorityclinical trials oversightquality management system
万方数据
维普
