Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Informs of New Guideline on Exemption from Bioequivalence Studies for Oral Drugs
The Ministry of Health, Labor and Welfare (MHLW) has issued a notification informing of ICH’s guideline on Biopharmaceutics Classification System (BSC)-based Biowaivers, which eliminates the need for bioequivalence studies of oral drugs under certain conditions. Biowaivers eliminate the need for…
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