Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Generic Drug Makers Required to Improve Package Inserts by Adding Information from Clinical Studies: MHLW Notification
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on April 13 requiring generic drug makers to further improve their package inserts by providing information comparable to that provided for original drugs in the pharmacokinetics and other sections.…
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REGULATORY
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