International scientific guideline: ICH Topic E 5 (R1) - Note for guidance on ethnic factors in the acceptability of foreign clinical data

About this guideline

Overseas effective date: 1 May 2000

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.