Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
COMMENTARY
Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
Japan is poised to make the most sweeping revision in eight years to the Standards for Biological Raw Materials — a regulation affecting a wide range of products, from pharmaceuticals to regenerative medicines. The revision aims to address outdated requirements,…
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