The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…
REGULATORY
MHLW Revises Safety Guidance on FIH Studies Following Death of Subject
The Pharmaceutical Evaluation Division of the Ministry of Health, Labor and Welfare’s (MHLW) Pharmaceutical Safety and Environmental Health Bureau has reported its revisions of its safety guidance to ensure the safety of first-in-human (FIH) studies in drug development, by adding…
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