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

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.