采用文献、访谈调研的方法,综合分析国内外药品安全预警相关的监管工作现状,探讨我国药品安全预警系统的构建模式。国内外药品安全预警特点差异明显,各有侧重。建议建立并完善我国药品安全预警系统,实时监测药品安全隐患。 By means of literature review and interviews, this paper comprehensively analyzes the current regulatory status of drug safety early warning at home and abroad and discusses the construction mode of early warning system of drug safety in our country. Differences in the characteristics of early warning of drug safety at home and abroad are obvious, each with its own focus. It is suggested to establish and perfect the early warning system of drug safety in our country and monitor the hidden dangers of drugs in real time.