Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
The International Council for Harmonization’s (ICH) S9 Guideline (Nonclinical Evaluation for Anticancer Pharmaceuticals) will apply to drugs that are intended to treat cancer in patients with serious and life threatening malignancies, and it will not determine the thresholds of seriousness…
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REGULATORY
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