Pharmacovigilance and Risk Management Strategies Conference

Under the 2010 Pharmacovigilance Legislation in the EU, the need to conduct signal detection in the Eudravigilance (EV) regulatory database was originally confined to the European Medicines Agency and the Member State Authorities. This situation was amended under the subsequent Implementing Regulation in 2012 to include Marketing Authorisation Holders; a step which led to concerns that this appeared to represent triplication of effort with no ostensible value to public health or patient safety. Following an industry position paper, the GVP guidance for signal management was revised in November 2017 with a 6-month implementation period granted. Importantly a one-year pilot was agreed in June 2017 with EMA and this was limited to the active substances under additional monitoring at the time (288 products), rather than include all products on the EU market at that time. This pilot was subsequently extended to December 2019 and then again to the end of 2021 following discussions with the European Commission. In the interim period, data were collected by multiple companies to assess the effectiveness of EV as an additional signal detection tool over and above existing data courses. This session will discuss the results of the data collected during the pilot, present feedback on the pilot noted by EMA, and highlight subsequent steps that have been agreed through to 2021.