Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
A Japanese health ministry panel on December 3 roughly endorsed an outline of an emergency authorization system that would grant approval for drugs and medical devices based on “presumed efficacy” as long as safety is “confirmed.” The Ministry of Health,…
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