Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Sets Exceptions to All-Case PMS through Revised Q&A
The Ministry of Health, Labor and Welfare (MHLW) has announced exclusion criteria for all-case post-marketing surveillance (PMS), which has been traditionally often imposed on new medicines as a condition for approval. The move comes as part of efforts to reduce…
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