The History and Status of the World Health Organization Pre-Qualification of In Vitro Diagnostics
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.
World Health Organizationprequalificationin vitro diagnosticshistorydevelopment status
万方数据
维普
