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...read more