Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW to Draft GL on Use of Real World Data in Application Filings to Promote Development of Drugs for Rare Diseases
The Ministry of Health, Labor and Welfare (MHLW) plans to draft guidelines for using real world data in marketing authorization applications for ethical drugs. The guidelines will cover requirements for using real world data from national patient registries as control…
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REGULATORY
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