Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Japan to Allow Submissions without Japanese Data If All Requirements Met
Members of a health ministry panel on pharmaceutical regulations on February 8 broadly agreed on a proposal to allow regulatory filings without clinical study data in Japanese patients if all requirements are met, such as the completion of pivotal trials…
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