EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
EudraVigilance supports safe and effective use of medicines by facilitating:
- electronic exchange of individual case safety reports between EMA, national competent authorities, marketing authorisation holders and sponsors of clinical trials in the EEA;
- early detection and evaluation of possible safety signals;
- better product information for medicines authorised in the EEA.
This electronic reporting is obligatory for marketing authorisation holders and sponsors for clinical trials.
The EudraVigilance system includes:
- a fully automated safety and message-processing mechanism using XML-based messaging;
- a large pharmacovigilance database with query and tracking functions.
It complies with the formats and standards of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
In this section
Registering and reporting
The EudraVigilance system
Release of data
EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports.
The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.
Analysis of data
EMA and national competent authorities are responsible for regularly reviewing and analysing EudraVigilance data to detect safety signals.
The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates the safety signals detected in EudraVigilance and may recommend regulatory action as a result.
For more information on how EMA interprets information on reported cases of suspected adverse reactions, see:
Enhancement of EudraVigilance
EMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. For more information, see:
The Agency will regularly update information and supporting documentation on this section of the website as the system develops. To help stakeholders prepare for the changes, EMA has developed a new training curriculum. For more information, see:
Replacement of the old EudraVigilance website
The EudraVigilance website https://eudravigilance.ema.europa.eu was de-commissioned in July 2016. All public information about EudraVigilance can now be accessed in this section of the EMA corporate website. Registered users will continue to be able to access the EudraVigilance restricted area as usual.
The enhancement of EudraVigilance follows the revised EU legislation on pharmacovigilance, which updated the legal framework for reporting and analysing suspected adverse reactions to improve health protection.
EMA publishes annual reports to provide a summary of the EudraVigilance-related activities the Agency undertakes within the European medicines regulatory network and with stakeholders:
- 2015 annual report on EudraVigilance for the European Parliament, the Council and the Commission
- 2014 annual report on EudraVigilance for the European Parliament, the Council and the Commission
- 2013 annual report on EudraVigilance for the European Parliament, the Council and the Commission
- 2012 - First annual report on EudraVigilance for the European Parliament, the Council and the Commission
- 2011 EudraVigilance Human annual report
- 2011 EudraVigilance Human annual report - Explanatory note
For more information on EMA activities, see Annual reports and work programmes.
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