Change management for the EudraVigilance system

The European Medicines Agency (EMA) launched an enhanced EudraVigilance system in November 2017, to support the changes to electronic reporting requirements for suspected adverse reactions brought about by the European Union (EU) pharmacovigilance legislation.

EMA continues to provide updates to stakeholders on further changes to the Eudravigilance system.

Guidance on using ISO standard format for individual case safety reports

As of 30 June 2022, EudraVigilance users need to report individual cases of suspected side effects using the ISO ICSR/ICH E2B(R3) format and related ISO standard terminology for pharmaceutical form and route of administration.

Revised guidance on the technical requirements and process for transmitting individual case safety reports (ICSRs) is available below. This helps pharmaceutical companies, sponsors of clinical trials and medicines regulatory authorities in EU Member States prepare to use the new ICSR standard.

The revised guidance also includes updates on:

The new business rules are available in the EudraVigilance test environment (XCOMP). They enable stakeholders to test changes to their own systems.  

For more information, see:

Features of the system

Guidance

A compilation of guidance is available below on the enhanced EudraVigilance system launched in 2017. 

For reference, this includes obsolete guidance on the use of the ICH E2B(R2) format for reporting individual cases of suspected side effects, which was possible until 30 June 2022. 

As of 30 June 2022, EudraVigilance users need to report individual cases of suspected side effects using the ISO ICSR/ICH E2B(R3) format. For more information, see Guidance on using ISO standard format for individual case safety reports.

Testing

Organisations preparing for electronic transmissions of ICSRs to EudraVigilance for the first time or performing major upgrades to established systems (e.g. submission of ICSRs in ICH E2B R3 format) should perform testing with EMA and consult EudraVigilance: electronic reporting for further information.

Guidance is available to support testing:

Guidance provided for 2017 launch

EMA published a question-and-answer document to address questions received from stakeholders in preparation of the launch of the new EudraVigilance system in 2017.


For more information, see:

Topics

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