The European Medicines Agency is responsible for the development, maintenance and coordination of EudraVigilance, a system designed for the reporting of suspected side effects.

Reports submitted to EudraVigilance include suspected side effects of medicines reported during both the pre- and post-authorisation phases. The system allows the detection of signals of suspected side effects that were previously unknown, and of new information on known side effects.

Data collected in EudraVigilance

EudraVigilance Clinical Trials module:

  • suspected unexpected serious adverse reactions (SUSARs) reported by sponsors of interventional clinical trials;

EudraVigilance Post-authorisation module:

Suspected serious and non-serious side effects from:

  • Healthcare professionals' and patients' spontaneous reporting;
  • Post-authorisation studies (non-interventional);
  • Worldwide scientific literature (spontaneous, non-interventional);

EudraVigilance data for authorised medicines are analysed on a regular basis, with a two-week or four-week frequency.
The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates signals from EudraVigilance and may recommend regulatory action as a result.

EudraVigilance is used by medicines regulatory authorities in the EEA, the Agency and pharmaceutical companies with marketing authorisations in the EEA.

The reporting obligations of the various stakeholders are defined in EU legislation, in particular Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC and Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Please refer to the main page of the EudraVigilance website for further information.
Details on the processes for the conduct of pharmacovigilance in the EU can be found in the Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products.

For more information on how the Agency interprets information on reported cases of suspected adverse reactions to medicines, see the Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines.