MAH药物警戒体系中外部报告递交质量管理分析与思考  

Compliance Management of External Reports Submission Quality in MAH Pharmacovigilance System

作　　者：徐建龙 王广平 胡骏 XU Jianlong;WANG Guangping;HU Jun(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12期1162-1167,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]。

摘　　要：我国《药品年度报告管理规定》要求药品上市许可持有人(MAH)落实药品年度报告的主体责任。落实MAH药物警戒外部报告递交合规管理的主体责任,可作为监督检查、风险评估、信用监管等工作的参考资料和研判的科学依据,也可作为地方药品不良反应监测能力建设的评价指标。本研究基于MAH药物警戒体系中的药品年度报告、个例安全性报告(ICSR)、定期安全性更新报告(PSUR)的概述,分析了MAH药物警戒外部报告递交合规管理的相关制度、组织框架和全生命周期药物警戒体系,提出了建立药物警戒能力建设评估指标、推进药物警戒质量受权人制度、加大药物警戒知识培训力度和融入企业数字化转型等外部报告质量体系建设的政策性建议。Regulations for Drug Annual Report requires the marketing authorization holder(MAH) to implement the main responsibility for drug annual reports.It is an important responsibility for the MAH to submit the external pharmacovigilance report for compliance management, which can be used as the reference material and scientific judgment for drug inspection, risk assessment, credit supervision and other work, and also can be used as the evaluation indicator of local adverse drug reaction(ADR) monitoring capacity. Based on overview of the drug annual reports, individual case safety reports(ICSR), and periodic safety update reports(PSUR) in MAH pharmacovigilance system, this study analyzed the relevant institutional regulations, organizational framework about submission compliance management of MAH pharmacovigilance external reports, and the whole life cycle pharmacovigilance system. Then the policy recommendations of pharmacovigilance external reports quality systems were put forward, such as the pharmacovigilance capacity evaluation indicators, pharmacovigilance quality authorized persons system, increasing pharmacovigilance knowledge training, and integrating into digital transformation.

关 键 词：药品上市许可持有人 药物警戒 外部报告 递交质量管理 

分 类 号：R951[医药卫生—药学]