Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Issues Safety Guidance for First-in-Human Trials
The Ministry of Health, Labor and Welfare (MHLW) has drawn up, for the first time, “Guidance for Ensuring Safety in First-in-Human Clinical Trials.” Preparations for first-in-human trials are already underway at five hospitals selected by the MHLW. The new Guidance…
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REGULATORY
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