Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Clarifies Use of Real-World Data in Drug Applications
Japan’s Ministry of Health, Labor and Welfare (MHLW) has clarified cases where real-world data (RWD) can be used in regulatory applications for pharmaceuticals. In a notification issued on February 27, the ministry said RWD could serve as supporting evidence in…
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