关于改进我国药品风险沟通的研究

Improvement of drug risk communication in China

文中通过研究国际药品注册协调委员会(ICH)的质量风险管理Q9(Quality Risk Management)中的风险沟通内涵和美国食品药品监督管理局(FDA)发布的系列风险沟通指南,分析了FDA风险沟通的特点,指出了我国药品风险沟通中存在的问题。借鉴美国的经验,就我国药品风险沟通的建设从科学性、针对性、互动性和时效性方面提出了建议。

Research on Quality Risk Management of ICH,the guidelines issued by FDA,has been done in the article.The features of drug risk communication of FDA have been analyzed.Some problems in the risk communication in China are pointed out.Learning from the experience of drug risk communication of FDA,we provided advices for the construction of drug risk communication in China,in the scientific,targeted,interactive and timely aspects.