Japan's Perspective on Facilitating Drug Development Through Asian Cooperation in Multi-Regional Clinical Trials: Insights From Regulatory Research.

Multi-regional clinical trials (MRCTs) have recently become a popular strategy for novel drug development, contributing to the early access to novel medicines in participating regions by enhancing development efficiency. To further facilitate MRCTs in Asia, the Japanese government has financially supported research activities in Japan for over 15 years that have studied the effect of ethnic factors on drug responses and identified practical challenges in conducting MRCTs in Asia. This mini-review highlights these research outcomes and related articles and presents our perspective on the current situation and future direction of MRCTs to explore opportunities for more collaboration between Japan and other East Asian/South-East Asian countries to facilitate drug development.