欧盟对安全性参考信息的要求及启示

Requirements for the reference safety information by European Commission and its implications for China

安全性参考信息的目的是判断可疑且严重不良反应的预期性,是申办者确定是否按照可疑且非预期严重不良反应的要求进行快速报告的重要信息。本文介绍了国际监管机构对安全性参考信息的要求,并详细介绍了欧盟临床试验促进小组发布的安全性参考信息的技术文件,为进一步规范研究者手册等安全性参考文件中安全性参考信息提供了有益的借鉴。

The primary purpose of the reference safety information is to serve as the basis for expectedness assessments of suspected serious adverse reactions by the sponsor for expedited reporting. This paper introduces the international authority requirements for reference safety information, especially the reference safety information-Q&A by Clinical Trials Facilitation and Coordination Group. It is of great value for us to study how to include the reference safety information in reference safety documents in investigator’s brochure.