4. EudraVigilance

1. EudraVigilance

1.2. Reports of suspected ADRs and other information

The reporting of suspected ADRs in a consistent way across the European Economic Area (EEA) is very important. Timely detection and assessment of safety signals from sources such as EudraVigilance complements the benefit-risk-balance evaluation of periodic safety update reviews and the assessment of risk management plans (RMPs) by the PRAC. EudraVigilance is therefore one of the cornerstones of EU pharmacovigilance as it helps to:

  • monitor the benefits and risks of medicines,
  • detect emerging safety signals
  • and decide on and initiate appropriate action.
Within EudraVigilance, signals are identified through regular analyses of reports on such events.

In short, a safety signal can be defined as new information related to a known ADR or any other event, either adverse or beneficial, and potentially causally related to the use of a medicine, that requires further investigation. See also lesson 1 for a detailed definition.

By facilitating electronic exchange of ICSRs between EMA, NCAs, MAHs and sponsors of clinical trials in the EEA, EudraVigilance is instrumental in ensuring the safety of medicines and early detection and evaluation of possible safety signals.