日本接受境外临床试验数据历程简介

An overview of acceptability of foreign clinical data in Japan

日本是最早提出种族差异概念和接受境外临床试验数据的亚洲国家之一。自1998年ICH E5《接受国外临床试验数据的种族因素指南》发布后,日本主要接受附加桥接研究的境外临床试验数据。2007年随着日本发布《国际临床试验基本原则》,国际临床试验数量快速增长,日本从桥接研究逐步转向国际临床试验策略。本文介绍了日本接受境外临床试验数据的发展历程,以期为业界参考。

Japan is one of the first Asian countries to propose the concept of ethnic differences and to accept foreign clinical data. After the adoption of ICH E5 in 1998, Japan mainly accepted foreign clinical data through the bridging strategy;after the publication of the "Basic Principles of International Clinical Trials" in 2007, global clinical trials grew rapidly in Japan. Currently, Japan has shifted from bridging strategy to global clinical trials strategy. This article discusses Japan’s experiences with the acceptance of foreign clinical data, in order to provide reference for the research and development of new drugs in China.