Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products - Scientific guideline

This document addresses the influence of pharmacogenomics on pharmacovigilance activities. It includes considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Keywords: Pharmacogenomics, pharmacovigilance, biomarkers, genomic variations

Current effective version

Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products

AdoptedReference Number: EMA/CHMP/281371/2013Summary:

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Document history - First version (current)

Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products

AdoptedReference Number: EMA/CHMP/281371/2013Summary:

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Overview of comments received on 'Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products'

Reference Number: EMA/CHMP/610677/2015

Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

Consultation dates: 30/01/2014 to 30/07/2014Draft: consultation closedReference Number: EMA/281371/2013Summary:

This guideline addresses the influence of pharmacogenomics on pharmacovigilance activities, including considerations on how to evaluate the pharmacovigilance related issues for medicinal products with pharmacogenomic associations, and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.

Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products

Consultation dates: 15/02/2012 to 15/05/2012Draft: consultation closedReference Number: EMA/CHMP/917570/2011Summary:

Currently, there is limited information on the utilisation of a genomic biomarker during follow up (post marketing) or on the effect of labelling with genomic information. Therefore, guidance is needed on the evaluation of genomic influences during pharmacovigilance activities in order to inform and improve clinical use of specific treatments. It is considered necessary to produce a guideline on the evaluation of pharmacogenomic specific issues in the conduct of pharmacovigilance. Document has republished with revised consultation dates.