Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Setting “Presumed Efficacy” Criteria Would Be Difficult; Xocova Decision Reasonable: PMDA Chief
Japan’s new emergency approval system was applied for the first time in 2022 after it was deemed possible to reasonably “presume” efficacy, but it would be difficult to establish clearcut criteria for such presumption, Yasuhiro Fujiwara, chief executive of the…
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