• Email
  • Help

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.

Enhancement of EudraVigilance

On 22 November 2017, EMA launched a new and improved version of EudraVigilance (human). The new system has enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders. 

The release follows EMA's Management Board confirmation in May 2017 that the EudraVigilance database delivers full functionality.

For more information, see:

EudraVigilance supports safe and effective use of medicines by facilitating:

  • electronic exchange of individual case safety reports (ICSRs) between EMA, national competent authorities (NCAs), marketing authorisation holders (MAHs) 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 of 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

Security principles and responsibilities

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:

Replacement of the old EudraVigilance website

The EudraVigilance website 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.

Annual reports

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:

How helpful is this page?

Average rating:

 Based on 114 ratings

Add your rating:

See all ratings
31 ratings
17 ratings
18 ratings
16 ratings
32 ratings

Tell us more

Login for registered users



Related content

Related EU legislation

Related documents

External links

Contact point:

For support with questions about pharmacovigilance, access to documents and other general enquiries:Send a question to the European Medicines Agency

For support with using EudraVigilance and EMA gateway/webclient: EMA IT Service Desk, Tel. +44 (0)20 3660 7523