International scientific guideline: ICH Topic E15 - Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

About this guideline

Overseas effective date: 25 February 2009

Categories: Multidisciplinary | Pharmacogenomics

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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.