Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Require RMP Submissions around August for Generics of Blue Letter-Issued Original Drugs
The Ministry of Health, Labor and Welfare (MHLW) will require generic manufacturers to submit risk management plans (RMPs) for generics when flash safety reports are issued to their original products. The MHLW is looking to release a notification regarding generic…
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REGULATORY
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