药品上市许可持有人药物警戒体系构建实证探索

Positive Research of MAH Pharmacovigilance System Construction

本文遵循《药物警戒质量管理规范》的实施要求,从上市许可持有人的具体实践出发,对药物警戒体系建设进行了系统分析,提出了药物警戒组织体系、职能体系、文件体系和保障体系的构建模式,开展了药物警戒关键活动和质量管理活动的实证探索,为上市许可持有人的药物警戒体系构建提供了有价值的实践经验。

This paper studies the MAH PV system construction based on the requirements of cGVP,systemically analyzes the system construction with the specific practice of MAH,puts forward the construction pathway of organization system,function system,file system,support system of PV,and conducts positive research of key activities&quality management in MAH PV system construction,which provides valuable practical experience for MAH PV system construction.