摘要
制药企业应按照中国法规要求上报产品相关不良反应,但目前在监管部门收集的药品不良反应报告数据库中,来自企业的报告比例很小。本文介绍了外资企业在国内通过建立不良反应收集系统,以增加收集不良反应报告的力度的方法。
To comply with regulation in China, pharmaceutical enterprise should report their products ADR to local authority. However, among the cases in local authority＇s database, the portion of report from enterprise is very small. This article introduces how to enhance the ADR reporting in international enterprise by establishing ADR collection system in China.
出处
《中国药物警戒》
2009年第11期698-699,共2页
Chinese Journal of Pharmacovigilance
关键词
药品不良反应
报告收集系统
质量控制
adverse drug reaction
report collection system
quality control
