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 Add Company-Driven Route to “Specific-Use Drug” Designations
Japan’s health ministry will introduce a new pathway from May 2026 allowing drug makers to ask the Pharmaceuticals and Medical Devices Agency (PMDA) to assess whether a product qualifies as a “drug for specific use.” “Drugs for specific use” is…
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REGULATORY
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