Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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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