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ICH topic E 5 (R1) - Questions and answers: Ethnic factors in the acceptability of foreign clinical data

We have adopted this International Scientific Guideline – ICH E5 (R1) Q&As; CPMP/ICH/5746/03 

Last updated

About this guideline

 Adopted by the TGA: 1 June 2014

For information:  June 2006

Note: This document answers questions concerning the issues addressed in ICH Topic E 5 (R1) Ethnic Factors in the Acceptability of Foreign Clinical Data (ICH E5 (R1); CHMP/ICH/289/95)

Categories: ICH | Efficacy

Clinical efficacy and safety | General 

TGA Annotations: Nil

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For more information see International scientific guidelines adopted in Australia.

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