摘要
世界卫生组织资格预认证(WHO PQ)是WHO向联合国儿童基金会提供的一项服务,用于评估候选疫苗的可接受性,为基金会购买符合一定标准的疫苗提供建议。目前已经涵盖4类产品,即疫苗、药品、体外诊断产品及病媒控制产品,其中体外诊断产品资格预认证(PQDx)是针对体外诊断产品的审评机制,为采购合适的诊断试剂提供科学依据。本文重点介绍了WHO PQDx的历史与发展现状,并以此探讨我国体外诊断制造商申请WHO PQDx的机遇与挑战。
The World Health Organization Prequalification(WHO PQ)program,a service provided by the WHO to the United Nations Children's Fund(UNICEF),assesses the acceptability of candidate vaccines and provides recommendations for purchasing vaccines that meet specific criteria.This program currently encompasses four categories of products:vaccines,medicines,in vitro diagnostics,and vector control products.The prequalification of in vitro diagnostic product(PQDx)is a review mechanism specific to in vitro diagnostic products,providing a scientific foundation for the procurement of suitable diagnostic reagents.This article focuses on the history and current status of WHO PQDx,and discusses the opportunities and challenges faced by China’s in vitro diagnostic manufacturers in applying for WHO PQDx.
作者
胡晋君
麻婷婷
刘东来
宋爱京
许四宏
张河战
张辉
HU Jin-jun;MA Ting-ting;LIU Dong-lai;SONG Ai-jing;XU Si-hong;ZHANG He-zhan;ZHANG Hui(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Medical Devices,NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics;National Institutes for Food and Drug Control)
出处
《中国食品药品监管》
2024年第8期12-21,共10页
China Food & Drug Administration Magazine
关键词
世界卫生组织
资格预认证
体外诊断产品
历史
发展现状
World Health Organization
prequalification
in vitro diagnostics
history
development status
