Symposium report summarizes stakeholders' views on Phase 1 trials in Japan, clarifying new guidelines 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.
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