Approval for New EudraVigilance system for collection and monitoring of suspected Adverse Reactions


The European Medicines Agency (EMA) will launch 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 version of EudraVigilance will go live on 22 November 2017 (announcement of the EMA Management Board) with enhanced functionalities for reporting and analysing suspected adverse reactions.

The enhancements for reporting and analysing suspected adverse reactions of the new EudraVigilance system will support better safety monitoring of medicines and a more efficient reporting process for stakeholders.

Expected benefits include:

  1. Simplified reporting of individual case safety reports (ICSRs) and the re-routing of ICSRs to Member States as marketing authorisation holders will no longer have to provide these reports to national competent authorities, but directly to EudraVigilance, which will ultimately reduce duplication of efforts. An ICSR provides information on an individual case of a suspected adverse reaction to a medicine;
  2. Better detection of new or changing safety issues, enabling rapid action to protect public health;
  3. Increased transparency based on broader access to reports of suspected adverse reactions by healthcare professionals and general public via the adrreports.eu portal, the public interface of the EudraVigilance database;
  4. Enhanced search and more efficient data analysis capabilities;
  5. Increased system capacity and performance to support large volumes of users and reports (including non-serious adverse reactions originating from the EEA);
  6. 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 Centre (UMC) directly from EudraVigilance; Member States will no longer need to carry out this task.

 

The Agency will 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. Users can trial the new functions of the EudraVigilance system and the internationally agreed format for ICSRs in a test environment as of 26 June 2017. Further information is available on the EudraVigilance training and support webpage.

If you want more info, just click on the links below:

EudraVigilance

EudraVigilance training and support webpage

Clinical Trial Regulation

Announcement of the EMA Management Board