Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors

In recent years, drug development has become dramatically globalized, and global clinical trials (GCTs) are being conducted in both International Conference on Harmonisation (ICH) and non-ICH regions. 1 To ensure the success of global drug development, ethnicity-related factors must be taken into consideration. In this article, the experiences and initiatives of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan are described, and the contours of an effective global drug development strategy are discussed.