药品生产企业在我国的上市后药品风险监测和控制现状分析  

Analysis of Drug Manufacturer on Post-marketing Drug Risk Monitoring and Management Status in China

作　　者：冯红云[1] 吴桂芝[1] 范燕[1] 董铎[1] FENG Hong-yun;WU Gui-zhi;FAN Yan;DONG Duo(Center for Drug Reevaluation,CFDA,Beijing 100045,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2018年第1期16-19,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的评估现阶段我国药品生产企业对上市后药品安全监测和风险控制现状,为提升我国药品生产企业的上市后药品安全风险的监测和控制能力提供依据。方法对我国药品不良反应监测数据库、相关文献资料以及国家食品药品监督管理总局公开发布的公告进行检索查询,从药品生产企业的药物警戒组织体系建设、药品不良反应/事件报告的收集、风险信号的发现和确认、以及药品风险的控制措施实施等方面进行了描述性分析。结果我国药品生产企业药物警戒组织结构已经基本建成,但报告收集、信号的发现、确定及控制能力有待提高。结论生产企业应该转变管理理念,拓宽工作思路,切实履行药品风险管理的责任。Objective To evaluate the drug manufacturer's abilities on the post-marketing drug safety monitoring and risk control at the present stage in China.Methods China adverse drug reaction(ADR)database,the literatures in domestic bibliographic databases,and the risk management measures in CFDA website were analyzed.Results The pharmcovigilance organizational system of drug manufacturers in China were established almost,but the abilities of ADR reports collecting,discovering and identifying the safety signals,and the implementation of the drug safety risk management measures need to be improved.Conclusion Drug manufacturers in China should change the management philosophy,expand the thinking of work,perform the duty of drug risk management practically.

关 键 词：药品生产企业 上市后 药品风险监测和控制 

分 类 号：R95[医药卫生—药学]