Change management for the launch of the new EudraVigilance system

The updated European Union (EU) pharmacovigilance legislation brought about significant changes to electronic reporting requirements for suspected adverse reactions, to support better safety monitoring for medicines and a more efficient system for stakeholders. To support these changes, the European Medicines Agency (EMA) launched the EudraVigilance system with enhanced functionalities on 22 November 2017.

Current requirements

StakeholderRequirement
EMA
  • To enhance EudraVigilance to deliver simplified reporting, better quality data and improved searching, enhanced analysis and tracking functionalities as well as extended access in particular for marketing authorisation holders
  • To make all individual case safety reports (ICSRs) for suspected adverse reactions that occur in the European Economic Area (EEA) available to the World Health Organisation (WHO) Uppsala Monitoring Centre (UMC) in a timely manner
Marketing authorisation holders
  • To monitor the EudraVigilance data they have access to for safety signals and to report these to EMA and national competent authorities
    EMA and the European Commission have agreed some transitional arrangements in order to streamline the implementation of this new process. For more information, see signal management
All stakeholders within the European Union (EU) medicines regulatory network

Benefits of the new EudraVigilance system

The new EudraVigilance system has several significant benefits, including:

New featureBenefit
  • Better detection of new or changing safety issues, enabling rapid action to protect public health
  • Improved quality and completeness of ICSR data
  • Better searchability and more efficient data analysis
  • Able to support an increased number of ICSRs due to the new requirement to report non-serious cases to EudraVigilance
  • Simplified reporting of ICSRs to EudraVigilance and the rerouting of ICSRs to Member States
  • Enhanced collaboration between EMA and WHO
  • Member States no longer need to carry out this task

EudraVigilance stakeholder change management plan

The detailed change management plan provides stakeholders with information on the technical changes EMA is introducing in the EudraVigilance system as well as business process changes required to work with the new system. EMA first published this document in October 2015 and the latest version of the plan in November 2017:

This provided a starting point for national competent authorities in the EEA, marketing authorisation holders and sponsors of clinical trials to develop their own internal implementation plans to prepare for the launch of the enhanced EudraVigilance system on 22 November 2017.

Eudravigilance high level plan


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Testing for the enhanced EudraVigilance system

EMA advised organisations that had already established electronic submission of ICSRs to EudraVigilance to perform the gateway configuration and communication testing with XCOMP (refer to the PDF iconEU ICSR Implementation Guide ) prior to the new EudraVigilance system launch on 22 November 2017.

Organisations that are continuing to use established E2B(R2) systems were advised to use the E2B(R3) test files available for download from the external compliance testing environment (XCOMP) and test the upload of the files in their local pharmacovigilance/safety system with a backwards-and-forwards conversion solution.

EMA released the following guidance documents to support 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.

EudraVigilance go-live strategy

To enable EMA to release an enhanced Eudravigilance system on 22 November 2017, a downtime period of 10 business days was required. A number of key EudraVigilance functionalities were entirely or partially unavailable from 8 to 21 November 2017. Additional EMA IT systems were also affected during that period.

To facilitate the transition, the EU Regulatory network's pharmacovigilance business team has prepared a EudraVigilance go-live plan and a technical note in consultation with the Pharmacovigilance Risk Assessment Committee (PRAC), the Clinical Trials Facilitation Group (CTFG) and the EudraVigilance Expert Working Group.

The plan outlined a set of detailed, sequenced tasks and activities, which were required prior to the new EudraVigilance production system launch, explained the handling of legacy data resulting from the downtime and described the agreed temporary arrangements with each national competent authority.

The technical note described the IT systems that were affected by the downtime and provided further instructions to competent authorities, applicants, marketing authorisation holders and sponsors of clinical trials.

In addition, a PDF iconCommunications plan for EMA and national competent authorities in the EEA described the EMA communication milestones with national competent authorities in the EEA that were part of the new EudraVigilance system go-live strategy. It identified the stakeholders affected, their needs and interests. Each Member State had the possibility to align its own communication strategy with the one prepared by EMA.

Technical and business process changes: questions and answers

  • The document below addresses questions received from stakeholders in preparation of the launch of the new EudraVigilance system. It summarises questions received through the Agency's service desk and as part of the technical and pharmacovigilance/EudraVigilance support webinars organised by the EMA. The document is regularly updated and should be consulted as a first reference before contacting the Agency's service desk.

PDF iconQuestions and answers on the launch of the EudraVigilance system received from stakeholders (updated 17/08/2018)

The questions and answers below are based on the PDF iconstakeholder change management plan . They also include detailed documentation on the changes in reporting, downloading and analysis of data.

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