EudraVigilance, the European Union’s central system for collecting and analysing adverse drug reaction reports, has undergone major updates in 2024. These changes aim to improve the quality of the data managed and the operational efficiency of the system, making it an even more reliable support for pharmacovigilance activities. Calin Lungu, CEO of DDCS, spoke about it during the European Pharmacovigilance Congress. Here is what emerged.

Main changes to EudraVigilance

Among the most notable changes introduced, a new information notice on EVWEB stands out, which clarifies the implications of the nullification of an Individual Case Safety Report (ICSR). The system now specifies that:

  1. Nullification always concerns the entire ICSR, not individual versions;
  2. Once an ICSR is nullified, it is not possible to send subsequent follow-ups for that case;
  3. In case of an error in the selection of the EV module, the report must not be nullified, but corrected and resubmitted to the correct module.

This measure was introduced to avoid common errors, providing clear instructions to users and improving data management.

Another innovation is the addition of a new business rule, which rejects amendment reports submitted without a previous version registered in the system. This rule was necessary to address a widespread problem: some companies mistakenly used amendment reports to resubmit cases rejected by EudraVigilance. This practice stemmed from a misinterpretation of the function of amendment reports, often confused with changes to a case without new data or changes to the starting date of Day 0. Now, rejected reports must be corrected and resubmitted, rather than treated as amendments.

Performance improvements

In addition to the new features, EudraVigilance has seen an overall improvement in its performance, including:

  • Significant reduction in disconnections during use;
  • Faster times for receiving acknowledgments;
  • Increased availability of the system, which can now also be used outside EMA working hours.

These improvements reflect EMA’s commitment to making EudraVigilance an increasingly stable and reliable tool for pharmacovigilance professionals.