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

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberEMA/CHMP/281371/2013
Effective from01/04/2016
KeywordsPharmacogenomics, pharmacovigilance, biomarkers, genomic variations
DescriptionThis 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..

Document history

First version

Current version

Adopted guideline

Overview of comments

Draft guideline

Concept paper

In operation: 01/04/2016–present

Published: 20/11/2015

Published: 30/01/2014

Published: 15/02/2012

Related content

How helpful is this page?

Average rating:

 Based on 15 ratings

Add your rating:

See all ratings
3 ratings
3 ratings
3 ratings
3 ratings
3 ratings

Tell us more