ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - Scientific guideline

This document recommends a framework for evaluating the impact of ethnic factors upon a medicine's effect, i.e., its efficacy and safety at a particular dosage and dose regimen. Read together withICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers.

Keywords: Foreign clinical data, regulatory requirements, extrapolation, ethnic factors, bridging study, global development

Current effective version

ICH: E 5 (R1): Ethnic factors in the acceptability of foreign clinical data - Step 5

AdoptedReference Number: CPMP/ICH/289/95Legal effective date: 01/09/1998