FDA与公众的药品安全信息交流指南对我国的启示

Communication to the Public Guidance of FDA's Drug Safety Information and the inspiration to our country

以美国FDA的药品安全信息交流指南的发布背景和主要内容介绍为主线进行分析。FDA药品安全性风险的评估和决策有组织和程序保证,信息交流具有双向性、连续性的特点,重视用药指导信息发布,针对不同目标人群使用不同的发布语言。FDA的经验为我国政府药品安全信息交流制度的建立提供参考和借鉴。

In this article, we described the backgrounds and main contents of FDA＇s Drug Safety Information Guidance communicating to the public, analyzed the characteristics of the Guidance. There are organizational and process assures when FDA reviews drug safety and the risk information, and makes decisions. The risk communication is bidirectional and consecutive, and emphasizes public health advisory information, in different languages for different special populations. All the experiences of FDA are good references for our government.