Better safety monitoring for patients across Europe

The European Medicines Agency (EMA) has launched today a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorisationholders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

The enhancements and expected benefits of the new EudraVigilance are:

  • simplified reporting of individual case safety reports (ICSR) and reduced duplication of efforts, as marketing authorisation holders no longer have to provide these reports to national competent authorities, but can send them directly to EudraVigilance;
  • better detection of new or changing safety issues, enabling rapid action by regulators to protect public health;
  • enhanced interoperability based on the use of the ISO/ICH agreed standard for individual case safety reports;
  • better searchability and more efficient data analysis;
  • increased system capacity to support large volumes of users and reports;
  • more efficient collaboration with the World Health Organization (WHO) as EMA will make the reports of individual cases of suspected adverse reactions within the EEA available to the WHO Uppsala Monitoring CentreExternal link icon (UMC) directly from EudraVigilance; Member States will no longer need to carry out this task.

Together with the launch, further legal obligations will become applicable to the mandatory electronic reporting through EudraVigilance, as stated in the announcement of the EMA Management Board published in May.

The reporting of adverse reactions by patients and healthcare professionals to national competent authorities based on local spontaneous reporting systems will remain unchanged. There will also be no changes to the reporting of suspected unexpected serious adverse reactions during clinical trials until the application of the new Clinical Trial Regulation. Public access to data held in EudraVigilance will be provided through the portalExternal link icon, which includes new features for data retrieval and representation.

The Agency will continue to support national competent authorities, marketing authorisation holders and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face trainings, webinars and information days.