Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Promote Master Protocol Trials to Boost Efficiency in New Drug Development
The Ministry of Health, Labor and Welfare (MHLW) is discussing how to streamline regulatory procedures for clinical studies using master protocols, which are expected to increase the efficiency of drug development in oncology and other fields. It plans to issue…
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REGULATORY
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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