Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Disclose Review Reports for Conditionally Cleared Regenerative Therapies Even If Full Approval Bid Dropped
The Ministry of Health, Labor and Welfare (MHLW) has issued new guidance clarifying that review reports for regenerative medicine products cleared under conditional and time-limited approval will be made public even if companies withdraw their applications for full approval. The…
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REGULATORY
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