EudraVigilance
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.
