Consultation: genomic influence on pharmacovigilance

1 February 2012

As we begin to understand the way genes impact on individual responses to prescribed therapies, current guidelines on the evaluation of medicines for clinical use may need updating.


The European Medicines Agency is seeking comments on its concept paper, which sets out a proposal to develop guidelines on the influences genomic information should have on pharmacovigilence activities.  These include the systematic consideration of the effects of genetic variability in safety monitoring of medicines, the use of biomarkers, the timing of the monitoring of genomic data and the information that should be provided in medicines' product information.

The consultation is open for comments until 15 March 2012. Comments should be sent to using the form for submission of comments.