Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Notifies Prefectures of RMP Submissions for Generics
The Ministry of Health, Labor and Welfare (MHLW) called on prefectures in its bulletin on August 26 to inform generic makers that the submission of risk management plans (RMPs) is now required when filing for the approval of generic versions…
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REGULATORY
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