个例安全性报告E2B规范的发展

摘要

ICH E2B目前已成为个例安全性报告(Individual Case Safety Report,ICSR)电子化传输的国际指南,被人用药物注册技术要求国际协调会(ICH)国家和非ICH国家的官方和企业界广泛采用.本文介绍了 E2B规范的背景及价值和近年来新发展,并结合我国目前不良反应监测系统的使用现状,讨论了在我国成为ICH成员国的背景下,实施 E2B规范的现实意义.%ICH E2B has now become the standard of ICSR electronic transmission, and is widely used by ICH countries and non-ICH countries' authorities and enterprises. This paper introduces background and value of ICH E2B standard and the progress of E2B standard; discusses the practical significance of implementing E2B standard in the context of China as a member of ICH and the current situation of national adverse drug reaction monitoring system in China.