美国药品上市后监测体系对我国落实企业报告责任的启示  

The Enlightens on Carrying out Reporting Responsibility of Manufactures in China from Reviewing the Post Marketing Surveillance System in US

作　　者：董铎[1] 吴桂芝[1] 王涛[1] 刘佳[1] 熊玮仪[1] 王丹[1] 

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》2017年第10期607-610,共4页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的通过介绍美国药品上市后监测体系,为我国落实企业主体责任提出建议。方法采用文献研究,全面了解美国药品不良事件报告制度、药品不良事件报告系统以及上市后药品不良事件报告检查等监测体系的相关方面。结果美国已建立比较完善的上市后监测体系,包括健全的法律法规、有效的检查机制等确保企业主体责任的落实。结论借鉴美国相关经验,从健全报告要求、报告范围、检查机制等方面促进我国企业报告责任的落实。Objective By introducing the post marketing surveillance system in the United States, it provided advice on carrying out mainl responsibility of manufacturer. Me thods Using literature review,it was showed the US surveillance system included general situation of the adverse event reporting, FDA adverse event reporting system（FAERS） and post marketing adverse drug experience（PADE） reporting inspection. Re s ults FDA has set up advanced post marketing system including systemic legislation and effective investigation mechanism to make manufacturer perform mainl responsibility. Conclus ion FDA provided the example and reference on requirements,scope,and inspection mechanism for carrying out reporting responsibility of manufacturers in China.

关 键 词：美国 上市后监测 药品不良反应监测 生产企业 

分 类 号：R95[医药卫生—药学]