Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
Japanese PI trials are not required as a rule before joining multi-regional clinical trials (MRCTs), and whether they are needed will continue to be determined scientifically—not simply based on procedural timelines, a senior regulatory official said on August 4. Yosuke…
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