EudraVigilance Survival Guide

EudraVigilance is the key organizational construct for the European Economic Area (EEA) and is anchored by a central database containing safety reporting (adverse events) and suspected unexpected serious adverse reactions (SUSARs) for marketed products and investigational drugs in clinical trials. By 4Q2017, EudraVigilance contained “more than 12.45 million safety reports, referring to 7.95 million cases, as well as information on 744,219 medicinal products on the EU market.”¹ Reporting of events in the form of individual case safety reports (ICSRs) as a part of EudraVigilance has been ongoing for several years; however, the requirement to use the EudraVigilance data to determine drug safety is a new regulation on the horizon.