EudraVigilance
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area. The European Medicines Agency operates the system on behalf of the European Union medicines regulatory network.
The European EudraVigilance system deals with the:
EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction .
The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions .
