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.
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 EudraVigilance registration process;
- the EudraVigilance business rules;
- data protection (i.e. legal references to the General Data Protection Regulation (GDPR) and the EU Data Protection Regulation (DPR);
- changes to reporting requirements for clinical trials that will apply after the go-live of the Clinical Trials Information System (CTIS).
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:
-
List item
Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of Administration (RoA) (PDF/148.63 KB)
First published: 03/02/2022
Last updated: 20/05/2022
EMA/580321/2021 Rev.1 -
List item
EudraVigilance: Obtaining EDQM terms from SPOR (PDF/352.13 KB)
First published: 03/02/2022
EMA/580322/2021 -
List item
Announcement of the EMA Management Board - Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology (PDF/203.26 KB)
First published: 15/01/2020
EMA/561671/2019 -
List item
European Union individual case safety report (ICSR) implementation guide (PDF/1.5 MB)
Adopted
First published: 30/04/2014
Last updated: 07/04/2021
Consultation dates: 30/04/2014 to 30/06/2014
EMA/51938/2013 Rev. 2 -
List item
EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (ZIP/308.54 KB)
First published: 11/07/2017
Last updated: 08/07/2022 -
List item
EU reference instances (EDQM revision) (ZIP/30.75 KB)
First published: 07/04/2021
Last updated: 04/06/2021 -
List item
European Union example instances - E2B(R3) testing files (ZIP/155.27 KB)
First published: 27/10/2015
Last updated: 08/07/2022
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.
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:
-
List item
European Union individual case safety report (ICSR) implementation guide (PDF/1.5 MB)
Adopted
First published: 30/04/2014
Last updated: 07/04/2021
Consultation dates: 30/04/2014 to 30/06/2014
EMA/51938/2013 Rev. 2 -
List item
EudraVigilance technical support plan for national competent authorities in the EEA (PDF/164.35 KB)
First published: 26/06/2017
Last updated: 22/09/2017
EMA/288788/2017 v 1.1 -
List item
EudraVigilance checklist for national competent authorities in the EEA (PDF/278.73 KB)
First published: 26/06/2017
Last updated: 26/06/2017
EMA/172253/2017 -
List item
EudraVigilance checklist and technical support plan for marketing authorisation holders and sponsors of clinical trials in the EEA (PDF/342.3 KB)
First published: 26/06/2017
Last updated: 26/06/2017
EMA/306740/2017
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: