Objective:To master the current situation of pharmacovigilance work carried out by marketing authorization holders in the administrative region,and provide reference for inspection and holders to carry out pharmacovigilance work.Methods:Statistical analysis was conducted using Excel on the personnel and resources,quality management and document records,monitoring and reporting,risk identification and assessment,risk control of 30 holders in the administrative region from pharmacovigilance inspections.Results:Although the holder has basically established a pharmacovigilance system,there are still some problems such as insufficient ability to actively collect adverse drug reactions,inadequate pharmacovigilance related training,incomplete content of system and procedural documents,and insufficient risk management capabilities.Conclusions:Holders should strengthen their awareness of self-collection,strengthen pharmacovigilance-related training,complete systems and procedural documents,and enhance risk management capabilities.The supervision department should further strengthen the organization and implementation of pharmacovigilance inspection.
关键词
药品上市许可持有人/药物警戒/药品不良反应/风险管理
Key words
marketing authorization holder/pharmacovigilance/adverse drug reactions/risk managemen
维普
万方数据