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

We have adopted this International Scientific Guideline – ICH E5(R1); CPMP/ICH/289/95

Last updated

16 December 2024

About this guideline

Overseas effective date: September 1998

Note: This should be read together with ICH: E 5 (R1): Questions & answers ethnic factors in the acceptability of foreign clinical data (ICH E5 (R1) Q&As; CHMP/ICH/5746/03)

Categories: ICH | Efficacy

Clinical efficacy and safety | General

TGA Annotations: Nil

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