EudraVigilance

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EudraVigilance is a web-based information system designed to manage information on reports of suspected adverse drug reactions. The European Medicines Agency (EMA) 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.

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 have been included in EudraVigilance since October 2014.

Analysis of data

EudraVigilance data are analysed regularly. EMA maintains a list of all medicines authorised through the Agency detailing the frequency of their monitoring:

The  Pharmacovigilance Risk Assessment Committee (PRAC) evaluates 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.

Enhancements based on the pharmacovigilance legislation

The new pharmacovigilance legislation brought about significant changes to electronic reporting requirements for suspected adverse reactions in order to deliver better health protection. The new legislation obliges:

  • EMA to enhance EudraVigilance through simplified reporting, better quality data and improved searching, analysis and tracking functionalities. These improvements help new or changing safety issues to be detected and action taken sooner;
  • marketing-authorisation holders to monitor Eudravigilance data they have access to.

These changes help to achieve:

  • compliance with international data standards, including future compatibility with the ISO-IDMP standards, as well as backwards and forwards conversion tools for E2B(R2)/(R3) messages;
  • improved performance and scalability to cope with foreseen increase in users and volume of data;
  • simplified reporting for marketing-authorisation holders.

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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