Good pharmacogenomic practice - Scientific guideline

This 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.

Keywords: Pharmacogenomics, good practices, pharmacogenomic analyses, biomarkers, study design, pharmacokinetics, DNA sequencing

Current effective version

Guideline on good pharmacogenomic practice - First version

AdoptedLegal effective date: 01/09/2018Reference Number: EMA/CHMP/718998/2016Summary:

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Document history - First version (current)

Guideline on good pharmacogenomic practice - First version

AdoptedLegal effective date: 01/09/2018Reference Number: EMA/CHMP/718998/2016Summary:

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Draft guideline on good pharmacogenomic practice - First version

Consultation dates: 02/05/2016 to 16/09/2016Draft: consultation closedReference Number: EMA/CHMP/268544/2016Summary:

The aim of this guideline is to lay out the requirements related to the choice of appropriate genomic methodologies during the development and life-cycle of a drug.

Concept paper on good genomics biomarker practices - First version

Consultation dates: 04/08/2014 to 04/11/2014Draft: consultation closedReference Number: EMA/CHMP/PGWP/415990/2014Summary:

Genomic data have become important to evaluate efficacy and safety of a drug for regulatory approval. As a result, genomic information has been increasingly included in drug labels relevant for the benefit/risk evaluation of a drug and consequently as guidance for patient treatment.