Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Mulls “Ultra-Orphan” Drug System; Designation Might Become Possible with Pre-Clinical, Healthy Subject Data
The Ministry of Health, Labor and Welfare (MHLW) is set to begin discussions on bettering its current orphan drug designation system, including the creation of an “ultra-orphan drug” scheme to expedite designation for medicines that treat extremely rare diseases—based possibly…
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REGULATORY
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