Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies in Japanese subjects prior to later-stage multinational trials as a general rule. The regulator hopes this will help prevent lags…
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