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European Medicines Agency

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EudraVigilance is the European data-processing network and management system, established at the European Medicines Agency to support the electronic exchange, management and scientific evaluation of Individual Case Safety Reports (ICSRs) related to all medicinal products authorised in the European Economic Area (EEA).

EudraVigilance also incorporates signal detection and data analysis facilities and is therefore regarded as one of the main pillars of the European Risk Management Strategy, which aims to strengthen the conduct of pharmacovigilance in the EEA.

Community legislation is in place to ensure that all stakeholders, including National Competent Authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA collect, collate and exchange adverse drug reactions.

The electronic transmission of ICSRs, based on the results of the International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) remains a priority in the area of pharmacovigilance to make  adverse reaction data exchange and management more efficient.

EVWEB is an Internet-based reporting tool developed by the European Medicines Agency to allow Small and Medium Size Enterprises (SMEs) that hold marketing authorisations in the EEA and sponsors of clinical trials, to report adverse reactions electronically, in full compliance with the internationally agreed standards to the European Medicines Agency and NCAs.