Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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