The European Medicines Agency (EMA) plans to launch a new version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area.

The new system will have enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders, according to the EMA.

The change-over from the current to the new version of EudraVigilance requires the transfer of more than 11 million individual case safety reports from the post-authorization phase and clinical trials as well as associated information. To allow the accurate transfer of such a large volume of data, some functionalities of the system will be entirely or partially unavailable for a period of ten working days, from November 8 to 21, 2017, according to the EMA.

The planned EudraVigilance downtime period will not affect the direct reporting of side effects by patients and healthcare professionals to national authorities in the European Union (EU) member states or to marketing authorization holders (MAHs), according to the EMA. Similarly, the publicly accessible European database of suspected adverse drug reaction reports will remain live.

Alternative reporting arrangements are being put in place to ensure that important processes can continue during the downtime. These include the established process for MAHs and sponsors of clinical trials to notify any emerging safety issues immediately to EU member states and the EMA.

Source: European Medicines Agency