Extrapolation of results from clinical studies conducted outside Europe to the EU-population - Scientific guideline
Table of contents
This document should be regarded as a reinforcement of the 
ICH E5 to be used when deciding whether certain clinical trials conducted in a specific area of the world would be relevant to the EU setting or if there are reasons to perform additional clinical trials within the EU.
Keywords: Extrapolation, ICH E5, global drug development, bridging studies, foreign clinical data, ethnicity, extrinsic factors
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Draft guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease (PDF/110.94 KB)
Draft: consultation closed
First published: 29/05/2009
Last updated: 29/05/2009
CHMP/EWP/1343/01 Rev. 1 -
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Concept paper on the development of a CHMP guideline on extrapolation results in clinical studies to the EU-population (PDF/37.25 KB)
First published: 24/01/2007
Last updated: 24/01/2007
EMEA/CHMP/EWP/7799/2007