Extrapolation of results from clinical studies conducted outside Europe to the EU-population - Scientific guideline

This document should be regarded as a reinforcement of the  ICH: E 5 (R1): Ethnic factors in the acceptability of foreign clinical data - Step 5 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

Current effective version

Reflection paper on the extrapolation of results from clinical studies conducted outside the European Union (EU) to the EU population

AdoptedLegal effective date: 01/05/2010Reference Number: EMEA/CHMP/EWP/692702/2008

Document history

Draft guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Draft: consultation closedReference Number: CHMP/EWP/1343/01 Rev. 1

Concept paper on the development of a CHMP guideline on extrapolation results in clinical studies to the EU-population

Reference Number: EMEA/CHMP/EWP/7799/2007