Public consultation opens on EMA’s draft guide on monitoring of medical literature

The European Medicines Agency has released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, for a two-month public consultation, on which stakeholders are invited to comment, no later than July 27.

The European Union's pharmacovigilance legislation has given the EMA responsibility for the monitoring of scientific and medical literature for a defined list of active substances used in medicines.

A key objective of this initiative is to improve safety monitoring of medicines through better quality of safety information from the literature entered into EudraVigilance, the EU pharmacovigilance database. In addition, it provides a service and reduces costs for industry by relieving companies holding authorizations for the monitored substances from having to enter the literature cases into EudraVigilance.