EMA gives go-ahead for new Eudravigilance System

The EMA announced on 23rd May that the enhanced EudraVigilance system will be launched on 22 November 2017. See the announcement here.

Users of the system, i.e. marketing authorisation holders and sponsors of clinical trials, should make suitable preparations to ensure that their processes and local IT infrastructure are compatible with the new system and the internationally agreed format.

The announcement also confirmed that the EVWEB XCOMP (test) environment of the new EudraVigilance System is planned to be released by the Agency on 26 June 2017. This will allow testing of the new EVWEB functionalities and the electronic transmission of Individual Case Safety Reports (ICSRs) in E2B(R2) or E2B(R3) format as applicable;

Registered users are reminded to check the validity of their user-IDs and passwords and to contact the EudraVigilance Registration team if user credentials need to be updated or if new users need to be registered; new users that would like to use the EVWEB XCOMP environment as of 26 June 2017, should initiate their registration as soon as possible by following the steps outlined at the dedicated Eudravigilance website. Existing registered users with valid log-in credentials will be automatically migrated to the new EVWEB XCOMP (as of 26 June 2017) and EVWEB production environment (as of 22 November 2017)

The Agency is supporting marketing authorisation holders and sponsors of clinical trials in the EEA through targeted e-learning and face-to-face training, webinars and information days. For further information click here.