A Brief Discussion on the Indicators of the Vigilance Function in WHO's Assessment of the National Regulatory Authority for Vaccines
In 2022,China successfully passed WHO's assessment of the national regulatory authority(NRA)for vaccines for the third time,achieving Maturity Level 3.This indicates that China has a stable,well-functioning,and integrated regulatory system to ensure the quality,safety,and effectiveness of vaccines,earning the trust and reliance of WHO and other international organizations and countries.In this paper,WHO global benchmarking tool(GBT)and the indicators of function vigilance are introduced.It also summarizes the comments and suggestions of WHO assessment experts regarding China's vaccine pharmacovigilance system,aiming to provide a reference for further development of China's vaccine vigilance system.
vaccinenational regulatory authorityWorld Health Organizationglobal benchmarking toolpharmacovigilance
万方数据
维普
