Definition · Plain-language
EudraVigilance
EudraVigilance is the European Medicines Agency’s system for collecting, managing and analysing reports of suspected adverse reactions to medicines that are authorised, or being studied in clinical trials, across the European Economic Area.
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What EudraVigilance is
EudraVigilance is the centralised European information system used to report and evaluate suspected adverse reactions to medicines. It is developed and maintained by the European Medicines Agency on behalf of the EU medicines-regulatory network. The system serves medicines authorised in the European Economic Area and products under study in clinical trials, providing a common database into which national competent authorities and marketing-authorisation holders submit individual case safety reports electronically using internationally agreed standards.
What it is used for
The system supports the electronic exchange of individual case safety reports, the early detection and evaluation of possible safety signals, and continuous monitoring of the benefit-risk balance of medicines. By consolidating reports from across member states into one analysable resource, EudraVigilance helps regulators identify emerging safety issues that might not be visible in any single country’s data. Outputs can inform regulatory decisions such as updates to product information, additional risk-minimisation measures or referrals for fuller scientific review.
How it fits the EU system
EudraVigilance operates within the EU pharmacovigilance legislation, which sets obligations for reporting and analysing adverse reactions. National regulators, marketing-authorisation holders and, through them, healthcare professionals and patients feed information into the network. Selected data are made available publicly through the European database of suspected adverse drug reaction reports. As with all spontaneous-reporting systems, a report describes a suspicion: it does not on its own confirm that the medicine caused the reaction, and report counts do not measure how frequently reactions occur.
Key facts
At a glance
- Definition: EMA system for managing and analysing suspected adverse-reaction reports.
- Operated by: European Medicines Agency (EMA).
- Scope: Medicines authorised or studied in the European Economic Area (EEA).
- Data unit: Individual case safety reports (ICSRs).
- Reporters: National regulators and marketing-authorisation holders.
- Purpose: Signal detection and ongoing benefit-risk monitoring.
Common misconceptions
What people often get wrong
Often heard: EudraVigilance is the European version of FAERS run by the same organisation.
Actually: They are separate systems run by different regulators: EudraVigilance is operated by the EMA for the EEA, while FAERS is operated by the US FDA. They follow international standards but are not the same database.
Often heard: Anything in EudraVigilance is a confirmed side effect of the medicine.
Actually: Reports describe suspected adverse reactions. A report reflects a suspicion of a link, not a confirmed causal relationship, and must be evaluated in context with other data.
Often heard: Only the EMA can put reports into EudraVigilance.
Actually: National competent authorities and marketing-authorisation holders submit reports into the system; the EMA maintains it and coordinates analysis across the network.
Going deeper
