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 Eyes Emergency Approval System Based on “Presumed” Efficacy
The Ministry of Health, Labor and Welfare (MHLW) plans to propose an emergency authorization system that would grant approval for products with a good benefit-risk balance based on their “presumed efficacy” as long as their safety is “confirmed.” According to…
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