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