摘要
我国的《药品不良反应报告和监测管理办法》强制要求药品生产企业内部建立药品不良反应报告和监测管理制度。通过分析企业建立报告制度的现状,借鉴欧盟的相关政策要求,探讨改进我国企业落实该报告制度的方法及政府监管方式。
Rules on adverse drug reaction reporting and monitoring in China require that pharmaceutical manufacturers should establish a management system for monitoring and reporting adverse drug reacdons（ADR）. Through observing the present situation of companies＇establishment and implementation of their standard operation procedures and ADk reporting structures, as well as analyzing relevant EU laws, this article discussed ways to improve our country enterprise to implement the reporting system and the mode of government supervision.
出处
《中国药物警戒》
2014年第1期8-11,共4页
Chinese Journal of Pharmacovigilance
关键词
药品生产企业
药品不良反应报告和监测
管理制度
pharmaceutical manufacturers
adverse drug reaction reporting and monitoring
management system
