Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Filing within 3 Months of Global Submission Eligible for Sakigake: MHLW
The Ministry of Health, Labor and Welfare (MHLW) on December 22 issued a notification updating its operational rule for the sakigake designation system, clarifying its eligibility requirement pertaining to the timing of regulatory submissions. One of its eligibility criteria, the…
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REGULATORY
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…