Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
Japan has started weighing the introduction of a withdrawal rule for its conditional approval system, which grants regulatory clearance with strings attached when PIII confirmatory trials are not feasible due to small patient populations or other such reasons. The Ministry…
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