Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Sets Up “Moderate-Risk” Post-Approval Change for Shorter Review
The Ministry of Health, Labor and Welfare (MHLW) has introduced a new category of post-approval procedures for “moderate-risk” manufacturing changes for ethical drugs, which would shorten the review period from the current median six months to 40 days. The new…
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