Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
AMED Launches Study on Evaluating the Quality and Safety of Nucleic Acid Medicines to Promote Their Development
A group of researchers from the National Institute of Health Sciences (NIHS) and Osaka University has begun studying how to evaluate the quality and safety of nucleic acid medicines to promote their development and increase its efficiency. The group, which…
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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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