EudraVigilance

The European EudraVigilance system deals with the:

• Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2B specifications):
  • EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs).
  • EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.
• Early detection of possible safety signals from marketed drugs for human use.^[1]
• Continuous monitoring and evaluation of potential safety issues in relation to reported adverse reactions.
• Decision-making process, based on a broader knowledge of the adverse reaction profile of drugs.

EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports.

The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.

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