The Ministry of Health, Labor and Welfare (MHLW) on September 19 proposed restructuring the Japanese generic industry by restricting the…
REGULATORY
Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
A Japanese health ministry panel on December 3 roughly endorsed an outline of an emergency authorization system that would grant approval for drugs and medical devices based on “presumed efficacy” as long as safety is “confirmed.” The Ministry of Health,…
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