Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Won’t Exclude Software Programs from Conditional Approval Coverage: Official
The Ministry of Health, Labor and Welfare (MHLW) will not exclude software programs such as therapeutic apps and diagnostic imaging software from the scope of products eligible for conditional early approval as long as requirements are met, according to the…
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REGULATORY
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Japan will overhaul its R&D tax credit regime in its FY2026 reform, introducing a new strategic category alongside existing frameworks.…
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