European Eudravigilance System
EudraVigilance is the European database 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 system has been operational since December 2001.
Reports are submitted electronically to EudraVigilance by national regulatory authorities, marketing authorisation holders and/or sponsors of clinical trials.
There are two modules for the collection of data within EudraVigilance database:
- The EudraVigilance Clinical Trial Module (EVCTM), designed to receive reports by sponsors on suspected unexpected serious adverse reactions (SUSARs) that occur in the frame of interventional studies;
- The EudraVigilance Post-Authorisation Module (EVPM), designed to receive spontaneous reports from:
- Healthcare professionals and patients ;
- Post-authorisation studies (non-interventional);
- Worldwide scientific literature;
- individual use (compassionate use, Law 648/96, named patient use)
All reports of suspected adverse reactions collected in the National Pharmacovigilance Network (RNF) are regularly submitted to Eudravigilance and vice versa, i.e. from Eudravigilance to RNF, only in relation to Italian reports that do not fall within the framework of clinical trials.
All reports submitted to Eudravigilance are also transferred to the World Health Organisation database (WHO) VigiBase, and are therefore available to all international competent authorities in the field of pharmacovigialnce in a short time period after submission.
Data from spontaneous reports of suspected adverse reactions for individual medicinal products are available in the Eudravigilance database (accessible from related link).
It should be borne in mind that these are suspected adverse reactions, i.e. clinical events observed following the use of a medicinal product, but not necessarily caused by a medicinal product; although these reports constitute a suspect, they remain an important source of information, as they allow the detection of potential warning signals related to the use of medicines and vaccines.
Only in-depth scientific assessments of all available data (derived from reports of suspected adverse reactions, clinical and epidemiological studies, published scientific literature and reports from pharmaceutical companies) can allow to draw conclusions based on risks and benefits and to intervene with regulatory actions to enable the safe use of medicines by patients