EudraVigilance

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EudraVigilance is a web-based information system designed to manage information on safety reports. The European Medicines Agency launched EudraVigilance in December 2001. Since then, it has extended the system to allow commercial and non-commercial sponsors to report suspected unexpected serious adverse reactions (SUSARs) occurring during clinical trials electronically.

The system is in full compliance with the specifications of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It includes:

  • a fully automated safety and message processing mechanism using XML-based messaging;
  • a large reference pharmacovigilance database incorporating an extensive query and tracking and tracing capability.

Release of data

Data from EudraVigilance are published in the European database of suspected adverse drug reaction reports.

This website allows users to view the total number of individual suspected-side-effect reports submitted to EudraVigilance for each centrally authorised medicine. Users can sort these reports by age group, sex, type of suspected side effect and outcome.

Reports for common drug substances used in nationally authorised medicines will be published during 2014. 

Analysis of data

EudraVigilance data are analysed at least every month. For some medicines this is done more frequently, at least every two weeks. A list of all medicines authorised through the Agency detailing the frequency of their monitoring is available:

The Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC) evaluate signals from EudraVigilance and may recommend regulatory action as a result. For more information on how the Agency interprets information on reported cases of suspected adverse reactions to medicines, see the guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines.

Table of contents


Access policy

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Document(s) Language Status First published Last updated Effective Date
EudraVigilance access policy for medicines for human use (English only) adopted 08/07/2011 23/08/2011 08/07/2011
Explanatory note: EudraVigilance access policy for medicines for human use (English only)   08/07/2011    
Overview of comments received on draft EudraVigilance access policy and implemented amendments (English only)   08/07/2011    
Draft EudraVigilance access policy for medicines for human use (English only) draft 18/12/2008    

Guidance

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