药品全生命周期药物警戒体系研究与思考  

Study and Consideration Pharmacovigilance System for Drug Whole Lifecycle

作　　者：王广平 WANG Guangping(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai 200040,China)

机构地区：[1]上海市药品和医疗器械不良反应监测中心,上海200040

出　　处：《中国医药导刊》2022年第7期637-642,共6页Chinese Journal of Medicinal Guide

基　　金：中国药品监督管理研究会2022年度研究课题[项目编号:2022-Y-Y-012;项目名称:药品监管质量管理规范(GRP)体系流程和标准建设路径研究];2020年度浙江省哲学社会科学规划课题[项目编号:20NDJC221YB;项目名称:大数据战略下浙江省药品高质量发展协同共治路径研究]。

摘　　要：当前,药品新业态新商业模式转变和数字化、信息化发展,对药品监管流程和监管方式提出了新的要求,需要采用全生命周期管理思维和数据赋能,以适应药品监管新变化、新趋势和新布局。药品全生命周期药物警戒体系是我国《“十四五”国家药品安全及促进高质量发展规划》《药物警戒质量管理规范》的制度要求,也是国际互认协议中重要制度之一。基于对我国药品全生命周期药物警戒体系的法律政策背景、建设现状和国际互认合规协议等的分析,本研究探讨了药品全生命周期药物警戒的系统思想、业务流程和相关制度文件等,重点分析了药品全生命周期药物警戒体系的霍尔(Hall)三维结构建设框架,并提出了信息化数字化建设、协调机制和质量受权人等相关的制度安排,以期为药品全生命周期药物警戒体系建设提供参考和借鉴。At present,the transformation of pharmaceutical new business models and the development of digitalization and informatization have put forward new requirements for drug supervision processes and methods.It is necessary to adopt whole lifecycle management thinking and data empowerment,which ingratiate to new changes,trends and layouts in drug supervision.The pharmacovigilance system is an important principle in“14th Five-Year Plan”for the National Drug Safety and Promotion of High-Quality Development,and in Good Pharmacovigilance Practice,and is also one of the important principles of the international mutual recognition agreements.Based on the analysis of the legal and policy background,construction status,and the international mutual recognition agreements,the study discussed the systemic thinking,business processes,the related institutional documents of pharmacovigilance system for drug whole lifecycle.Specifically,the study analyzed the Hall Three-Dimensional Structure construction framework of pharmacovigilance system for drug whole lifecycle and proposed the institutional suggestion,such as the digitalization and informatization,coordination mechanism,and the qualified person,which would provide reference for the construction of pharmacovigilance system for drug whole lifecycle.

关 键 词：药品监管 全生命周期 药物警戒 

分 类 号：R951[医药卫生—药学]