4. EudraVigilance

1. EudraVigilance

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EudraVigilance (EV) is a centralised European Union (EU) system for managing and analysing information on suspected adverse reactions (ADR) to a medicine. It is the tool that the EMA and NCAs use for the monitoring of the safety of all medicines authorised or being studied in clinical trials in the European Economic Area (EEA). It was created and is operated by the European Medicines Agency and has been in use since December 2001.

The EudraVigilance system includes a fully automated safety and message-processing mechanism and a large centralised pharmacovigilance database with query and tracking functions, which serves the early detection of potential safety signals and their evaluation. EudraVigilance also incorporates the Medical Dictionary for Regulatory Activities (MedDRA).

• EudraVigilance is composed of the following main system components supporting functions:
• Data processing and management system components
• EudraVigilance Gateway, a data-processing network for the secure electronic exchange of ADR data.

• EudraVigilance Post-Authorisation Module (EVPM) for collection of Individual Case Safety Reports (ICSRs) (a document providing information related to an individual case of a suspected adverse reaction due to a medicine) related to all medicinal products authorised in the EEA (Regulation (EC) No 726/2004 and Directive 2001/83/EC). The following ICSR types are collected in EVPM: “Spontaneous Report”, “Report from Study” with study type: “Individual patient use” (e.g., ‘compassionate use’ or ‘named patient basis’) and “Other studies”, “Other” (e.g., pharmacoepidemiology, pharmacoeconomics, intensive monitoring) and “Not available to sender (unknown)”;

• EudraVigilance Clinical Trial Module (EVCTM) for collection of ICSRs of Suspected Unexpected Serious Adverse Reactions (SUSARs) (Directive 2001/20/EC and Regulation (EU) No 536/2014 on clinical trials). The following ICSR types are collected in EVCTM: “Report from Study” with study type: “Clinical Trials” (interventional studies).

• eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD), reference source for coding

Note: EVPM and EVCTM can be accessed by registered users through EVWEB, a web interface with a set of functionalities to aid the creation, electronic reporting of and access to ICSRs. EVWEB includes the ICSR Export Manager, which permits the download of ICSRs in the internationally agreed format.

Data analysis and signal detection component

Adrreports.eu portal