健全药物临床试验期间安全性数据快速报告制度及加强临床试验风险监测管理

Enhancing the system of expedited reporting of safety data during clinical trials of drugs and strengthening the management of clinical trial risk monitoring

药物临床试验期间安全性数据快速报告制度的建立与实施,对于完善我国药物临床试验期间药物警戒相关技术体系和制度建设、加强对于药物临床试验风险监管、保护受试者安全,具有非常重要的意义。本文阐述了我国目前实施药物临床试验期间安全性数据快速报告制度的现状以及对于今后相关工作的思考。

The establishment and implementation of the standards and procedures for expedited reporting of safety data during clinical trials of drugs is of great significance for improving the technical and institutional system of pharmacovigilance during clinical trials of drugs in China,and for strengthening the risk regulation of clinical trials and protecting the safety of subjects.In this paper,we described the current situation of its implementation in China and the thinking of how to improve the future work.