www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500160232&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc

Guidelines & Recommendations

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

Policy recommendations on using genomic big data for health, by Dr Philippa Brice, PHG Foundation, Feb 17

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

• Email
• Help

Document details

Download document	Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products
Reference number	EMA/281371/2013
Status	draft: consultation open
First published	30/01/2014
Last updated	30/01/2014
Consultation start date	30/01/2014
Consultation end date	30/07/2014
Email address for submissions	PGWPSecretariat@ema.europa.eu

Summary

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.