美国药品生产企业上市后监测制度研究及启示

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (8): 456-459.

美国药品生产企业上市后监测制度研究及启示

董铎,刘翠丽

国家食品药品监督管理局药品评价中心,北京 100045

收稿日期:2013-06-25 修回日期:2016-03-09 出版日期:2013-08-08 发布日期:2016-03-09
作者简介:董铎,女,副主任药师,博士,药品不良反应监测。

The Revelation of Study on Drug Manufacture Post Marketing Surveillance System in the United States

DONG Duo ,LIU Cui-li

Center For Drug Reevaluation, SFDA, Beijing 100045, China

Received:2013-06-25 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

摘要/Abstract

摘要： 通过对美国药品生产企业上市后监测制度的介绍,全面了解美国药品生产企业不良事件报告概况、强化药品生产企业上市后监测的管理要素以及监管机构内部的协调管理机制,为完善和发展我国药品生产企业不良反应报告和监测制度体系提供借鉴和参考。

关键词: 美国, 药品, 生产企业, 上市后监测, 药物警戒

Abstract: By introducing the system of drug manufacture post marketing surveillance in the United States, it helped to know the general situation of manufacture adverse event reporting, supervision elements to strengthen manufacture post marketing surveillance and the coordination mechanism of internal organizations. It provided the example and reference for perfecting and developing adverse drug reaction reporting and monitoring system of drug manufacture in China.

Key words: the United States, drug, manufacture, post marketing surveillance, pharmacovigilance

中图分类号:

R951

董铎,刘翠丽. 美国药品生产企业上市后监测制度研究及启示[J]. 中国药物警戒, 2013, 10(8): 456-459.

DONG Duo ,LIU Cui-li. The Revelation of Study on Drug Manufacture Post Marketing Surveillance System in the United States [J]. Chinese Journal of Pharmacovigilance, 2013, 10(8): 456-459.

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