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.

Key activities and developments 201820

EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted the EudraVigilance operational plan from 2018 to 2020. This follows the launch in November 2017 of the new EudraVigilance (human) system with enhanced features for the reporting and analysis of suspected adverse reactions. For more information, see EudraVigilance change management and EudraVigilance training.

The plan describes key activities and developments that will take place between 2018 and 2020 and their impact on EudraVigilance and its stakeholders:

EMA will update the plan and corresponding timelines regularly.

EudraVigilance supports safe and effective use of medicines by facilitating:

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:

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:

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