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

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

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.

Open consultation

Concept paper on the guideline revision on good pharmacogenomic practice

Draft: consultation closed Consultation dates: 09/12/2025 to 31/03/2026 Reference Number: EMA/282050/2025 Summary:

The proposed revised guideline will replace the 'Guideline on good pharmacogenomic practice' (EMA/CHMP/718998/2016). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Document history

Guideline on good pharmacogenomic practice - First version

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

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

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

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

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

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.