Good pharmacogenomic practice

Current effective versionAdopted guideline
Adopted guideline enters into effect 01/09/2018
Reference numberEMA/CHMP/718998/2016
Published19/03/2018
KeywordsPharmacogenomics, good practices, pharmacogenomic analyses, biomarkers, study design, pharmacokinetics, DNA sequencing
DescriptionThis document describes requirements related to the choice of appropriate genomic methodologies during the development and the life-cycle of a drug. It discusses the principles for a robust clinical genomic dataset. It also highlights the key scientific and technological aspects for the determination and interpretation of the genomic biomarker data and their translation into clinical practice.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline



PDF iconConcept paper

Published: 19/03/2018
Effective from: 01/09/2018

Published: 02/05/2016



Published: 04/08/2014


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