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

About this guideline

TGA adopted date: 1 June 2014

Categories: Clinical efficacy and safety | General (clinical)

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For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.