The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Unveils Planned Framework for Conditional Early Approval Scheme
The Ministry of Health, Labor and Welfare (MHLW) on September 28 presented a planned framework for an envisioned “conditional early approval system,” which would apply to treatments for serious diseases for which confirmatory clinical studies are difficult to conduct. Under…
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