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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.