Symposium Report: Stakeholders' Perspectives on Phase 1 Trials in Japanese Prior to Multi-Regional Clinical Trials and Future Pathways.

A new guideline clarifying basic principles for conducting a phase 1 trial in Japanese prior to multi-regional clinical trials was issued in December 2023 to streamline global drug development and accelerate access to novel drugs. To foster a shared understanding of the guideline and discuss future pathways, the regulatory agency and industry jointly organized a public symposium. This report summarizes the proceedings of the symposium.