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

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Current effective version

Reflection paper

Reference numberCHMP/EWP/692702/08
Effective from01/05/2010
KeywordsExtrapolation, ICH E5, global drug development, bridging studies, foreign clinical data, ethnicity, extrinsic factors
DescriptionThis 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.

Document history

First version

Current version

Reflection paper

Draft reflection paper

Concept paper

Published: 30/04/2010

Published: 29/05/2009

Published: 24/01/2007

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