Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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MHLW Eyes 2 Year Transition for Electronic Data Submissions for New Drugs, Biosimilars
Japan’s health ministry plans to require drug makers to file patient-by-patient electronic data for their PII/PIII clinical studies when they seek regulatory approval for new drugs and biosimilars, beginning sometime in FY2016, but it will set a transition period of…
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