Japan plans to revise its guidelines on the drone delivery of medicines later this month, which would mark the first revision since they were established two years ago. Service providers are closely watching how they will be revised, with calls…
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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