摘要
通过研究国内外药品不良反应监测体系建设的发展规律和现状,分析我国药品不良反应监测体系建设存在的问题,从制度层面探讨加强药品不良反应监测体系建设的思路。药品不良反应监测在我国药品安全监管工作中发挥了重要作用,应从法律法规层级进一步强化药品不良反应监测的制度化管理,建设省级以下药品不良反应监测机构,完善我国药品不良反应监测体系。
Through studying the development laws and the status quo of the adverse drug reaction （ADR） monitoring system at home and abroad, analyzed the problems in the construction of ADR monitoring system and explored the method to strengthen the ADR monitoring system at the institution level. ADR monitoring has played an important role in Chinese drug safety supervision, the institu- tionalization of management for ADR monitoring system should be further strengthened through laws and regulations. The ADR monitoring institution under the provincial level should be constructed to improve the ADR monitoring system.
出处
《中国药物警戒》
2009年第2期74-79,共6页
Chinese Journal of Pharmacovigilance
基金
国家食品药品监督管理局<药品管理法>修订项目
关键词
药品不良反应监测
体系建设
制度
研究
adverse drug reaction （ADR）monitoring
system construction
institution
research
