Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Officially Drops Japanese PI Requirement before Global Trial Entry
Japan’s health ministry on December 25 clarified its position that additional PI studies in Japanese subjects prior to the country’s participation in multiregional clinical trials (MRCTs) are “not needed” as a general rule. The Ministry of Health, Labor and Welfare…
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