美国药品不良反应监测体系简介及对我国的启示

A Brief Introduction of the ADR Supervision System of FDA and Its Enlightenment to China

通过查阅资料和文献,从法律法规、组织机构、信息系统三方面介绍美国食品药品监督管理局的药品不良反应监测现状,为我国的药品不良反应监测工作提供建议。我国应进一步完善法律法规体系、组织机构和信息系统,提高药品不良反应监测水平。

This paper introduced the status quo of the ADR monitoring system of FDA including laws and regulations, organizations and information system based on literature review so as to provide a reference for the ADR supervision in China. It was suggested that further efforts should be made in China to improve the law and regulation system, organization and information system so that the ADR monitoring level can be raised.