Concept paper on good genomics biomarker practices

  • Email
  • Help

Document details

Download document Concept paper on good genomics biomarker practices
Reference number EMA/CHMP/PGWP/415990/2014
Status draft: consultation open
First published 04/08/2014
Last updated 04/08/2014
Consultation start date 04/08/2014
Consultation end date 04/11/2014
Email address for submissions pgwpsecretariat@ema.europa.eu

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.