解读世界卫生组织药品预认证项目  

Introduction and analysis of WHO's prequalification of medicines programme

作　　者：张宁[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国新药杂志》2014年第6期645-649,659,共6页Chinese Journal of New Drugs

摘　　要：世界卫生组织于2001年启动了药品预认证项目,旨在使更多的患者获得安全有效、质量可控的药物。本文对世界卫生组织药品预认证项目的认证范围、认证程序、认证原则、技术资料要求等进行解读;并在同国内仿制药品注册审评审批现状进行比较的基础上,提出了我国药品审评审批体制中值得借鉴的方面,即有效的引导、系统的培训、明晰的技术指导原则、有效的数据整合管理、系统的质量保证体系。相信随着WHO药品预认证项目的推进,中国制药企业对于预认证项目的了解加深,越来越多的中国制药企业会参与WHO预认证申请。World Health Organization initiated Prequalification of Medicines Programme （PQP） in 2001, aims to make quality priority medicines available to the benefit of those needed. The scope, procedure, assessment rule and requirement for Prequalification of Medicines were introduced and analyzed. Based on the comparison with the current status of medicines regulation in China, the followings were worthy to learn： effective guide, compre- hensive training, vivid guidance, data-integration management and quality assurance system. It＇s believed that more and more Chinese Pharmaceutical manufacturers will join Prequalification of Medicines Programme with more under- standing of PQP.

关 键 词：药品 预认证 世界卫生组织 

分 类 号：R95[医药卫生—药学]