Eudravigilance

Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.

The system provides individual components performing specific tasks associated with the electronic reporting of adverse drug reactions:

• EV gateway: a hub connecting MAHs, sponsors and NCAs; provides secure messaging.
• EVWEB, EudraVigilance web reporting application: an interface tool for the ‘manual’ creation, sending and view of ICSRs, safety and acknowledgment messages; designed for SMEs without fully ICH-compliant PV systems; allows for auto re-routing of ICSRs to NCAs and export (downloads) of ICSRs for MAHs.
• EDBMS, EudraVigilance database management system: processing and administration of messages and ICSRs, comprising EVPM (post-authorisation module) for ICSRs for authorised EEA medicinal products and EVCTM (clinical trial module) for suspected unexpected serious adverse reactions (SUSARs) from clinical trials. It is the data source for EVDAS.
• EVDAS, EudraVigilance data analysis system: focusses on signal detection and evaluation of ICSRs
• Adreports.eu: publicly accessible portal for search and view of EudraVigilance data for authorised medicinal products.
• XEVMPD, extended EudraVigilance medicinal product dictionary (also known as Article 57 database): supports the EudraVigilance system, containing authorised medicines and investigational medicines being used/used in clinical trials approved in the EEA. Sponsors and MAHs are required to provide and maintain this information.