On 22 November 2017, 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 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.
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-authorisation 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 8 to 21 November 2017.
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 authorisation holders (MAHs). 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 in particular the established process for MAHs and sponsors of clinical trials to notify any emerging safety issues immediately to EU Member States and EMA.
The EudraVigilance go-live plan describes the alternative reporting arrangements for suspected adverse reactions for authorised medicines by national authorities and MAHs in the EEA, and of suspected unexpected serious adverse reactions (SUSARs) for products subject to investigation by sponsors of clinical trials. This plan has been prepared in collaboration with the Pharmacovigilance Risk Assessment Committee (PRAC) and the Clinical Trials Facilitation Group (CTFG).
The Technical Note describes the IT systems, including EudraVigilance, which will be affected by the planned downtime and provides further instructionsto Member States, applicants, MAHs and sponsors of clinical trials.