摘要
2022年8月23日,世界卫生组织(WHO)宣布我国第三次通过疫苗国家监管体系(NRA)评估。本次评估采用了最新的全球基准评估工具(GBT),其高度重视监管绩效,主要体现在GBT九个板块均设置了关于监管绩效的主指标和亚指标。本文对GBT九个板块中关于监管绩效的主指标和亚指标进行了概述,并介绍了北京市药品检验研究院在实验室检验和批签发两个板块中建立绩效指标、实施绩效评估的探索和实践,以期为我国疫苗检验和批签发管理工作提供借鉴与参考。
On August 23,2022,China's national vaccine regulatory system passed the third formal assessment of the World Health Organization(WHO).This assessment adopted a brand-new Global Benchmarking Tool(GBT),which attaches great importance to regulatory performance.The GBT includes main indicators and sub-indicators related to regulatory performance in nine functions.This paper summarizes the main indicators and sub-indicators in the nine functions of GBT,and introduces the exploration and practice of establishing performance indicators and implementing performance evaluation in the two functions of Laboratory Testing and NRA Lot Release by the Beijing Institute for Drug Control,aiming to provide valuable insights and references for the management of vaccine testing and lot release in China.
作者
施捷
周荔
赵雨丹
戴红
郭洪祝
SHI Jie;ZHOU Li;ZHAO Yu-dan;DAI Hong;GUO Hong-zhu(Beijing Institute for Drug Control(Beijing Center for Vaccine Control))
出处
《中国食品药品监管》
2023年第7期22-29,共8页
China Food & Drug Administration Magazine
关键词
疫苗
世界卫生组织
国家监管体系
监管绩效
绩效评估
vaccines
World Health Organization
national regulatory authority
regulatory performance
performance evaluation
