Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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