EudraVigilance change management

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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) will launch the EudraVigilance system with enhanced functionalities on 22 November 2017.

New requirements

StakeholderRequirement
EMA
  • To advance 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
All stakeholders within the European Union (EU) medicines regulatory network
  • To implement simplified reporting procedure for ICSRs in the EU, with EMA receiving ICSRs from marketing authorisation holders and forwarding the reports to the national competent authorities concerned
  • To report non-serious cases of suspected adverse drug reactions that occur in the EEA to EudraVigilance
  • To use international data standards, including the International Organization for Standardization (ISO)/ICH E2B(R3) data structure for individual case safety reports (ICSRs)

Benefits of the new EudraVigilance system 

The new EudraVigilance system will have several significant benefits, including:

New featureBenefit
  • Enhanced signal-detection and data-analysis tools to support safety monitoring directly by Member States and marketing authorisation holders
  • 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
  • Enhanced scalability of the EudraVigilance system
  • 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
  • Reduced duplication of efforts
  • Marketing authorisation holders no longer have to provide ICSRs to national competent authorities, they have to submit these to EudraVigilance only 
  • Enhanced collaboration between EMA and WHO
  • Member States will no longer need to carry out this task

EudraVigilance stakeholder change management plan (updated)

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 published this updated version of the plan in June 2017:

National competent authorities in the EEA, marketing authorisation holders and sponsors of clinical trials should use this document as a starting point to develop their own internal implementation plans to prepare for the launch of the enhanced EudraVigilance system on 22 November 2017.

 


 

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Testing in preparation for the enhanced EudraVigilance system (new)

It is important for organisations who have already established electronic submission of ICSRs to EudraVigilance to perform the gateway configuration and communication testing with XCOMP (refer to the EU ICSR Implementation Guide) in advance of the launch of the enhanced EudraVigilance system on 22 November 2017.

Organisations that will continue to use established E2B(R2) systems should 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. 

Organisations should refer to the following documents for the preparatory testing:

Organisations should only contact the Agency if they encounter difficulties with the testing.

Organisations preparing for electronic transmissions of ICSRs to EudraVigilance for the first time or performing major upgrades to established systems should consult EudraVigilance: electronic reporting

EudraVigilance go-live strategy (new)

In preparation for the launch of the enhanced EudraVigilance system, EMA's pharmacovigilance business team is preparing a go-live strategy in collaboration with the EudraVigilance Expert Working Group and the Pharmacovigilance Risk Assessment Committee (PRAC).

EMA will publish a EudraVigilance go-live plan in this section in Q4 2017. The plan will include key milestones for stakeholders and will outline aspects such as the scheduled downtime of EudraVigilance prior to 22 November and the reporting arrangements all stakeholders should follow.

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 will be regularly updated and should be consulted as a first reference before contacting the Agency’s service desk. 

Questions and answers on the launch of the EudraVigilance system received from stakeholders

  • The questions and answers below are based on the stakeholder change management plan. They also include detailed documentation on the changes in reporting, downloading and analysis of data. EMA will regularly update information and supporting documentation on this webpage as the system develops. Concerned stakeholders should regularly monitor this webpage for updates.

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What are the technical changes to the EudraVigilance system?

The main technical change to the EudraVigilance system will be the implementation of the new ISO ICSR format for the submission and exchange of ICSRs in line with the applicable ICH E2B(R3) and EU ICSR Implementation Guides. 

To incorporate the new format, EMA will implement several changes in EudraVigilance. These include:

  • adapting the EudraVigilance Gateway, the secure electronic communication tool to exchange ICSRs, to accept ICH E2B(R2) as well as (R3) files;
  • adapting the EudraVigilance database management system (EDBMS) to support the storage and processing of reports submitted with the new ICH ICSR format
  • migrating all existing ICH E2B(R2) ICSR data to the new ICH ICSR format;
  • redesign of EVWEB, the web application for the electronic reporting and management of ICSRs in the ISO ICSR format, using a new technology;
  • introducing new functionalities in the EudraVigilance data analysis system (EVDAS), including the adrreports.eu portal, to support analysis of data and support signal management activities.

In addition, EMA will add the following two new functionalities to the system:

  • EudraVigilance rerouting functionality, which defines the rules for the forwarding of ICSRs to the national competent authority (NCA) where the adverse reaction occurred (rules can be set by NCAs according to their needs and preferences); 
  • ICSR download functionality to enable marketing authorisation holders to download ICSRs concerning their products or ICSRs reported with a substance for which they hold a marketing authorisation in the EEA.

The extended EudraVigilance medicinal product dictionary will no longer be an integral part of EudraVigilance version 8 but will continue to be available as an independent system component.

How will changes to the EudraVigilance affect business processes?

The implementation of the new EudraVigilance system will change the following business processes:

  • Marketing authorisation holders will no longer provide ICSRs to national competent authorities and must submit these to EudraVigilance only.
  • Following the switch to simplified reporting, EMA will submit ICSRs through EudraVigilance to the WHO Uppsala Monitoring Centre, rather than national competent authorities doing this;
  • Marketing authorisation holders will have a legal obligation to monitor the data available in EudraVigilance and inform EMA or national competent authorities of any safety signals identified. EMA will grant marketing authorisation holders access to EVDAS to use signal detection, analytical and reporting functions to the extent necessary to fulfil their obligation.

For more in-depth analysis of the changes to each stakeholder group, see:

All impacted organisations should prepare for the changes in reporting, downloading and analysis of data before the new EudraVigilance system is moved into production.

National competent authorities should plan communication activities at national level to ensure that marketing authorisation holders in their territory are aware of the changes and have systems in place to comply with their obligation to report directly to EudraVigilance, prior to the move to simplified reporting in 2017.

What should national competent authorities do to prepare for the change?

Activities that national competent authorities must and should do are below.

PeopleInformation

Must

  • Staff to undergo training on:
    • Use of the new ICH E2B(R3) format
    • EVDAS
    • GVP Modules VI (revision 2)
    • GVP Modules IX (revision 1)
    • EudraVigilance Access Policy

EudraVigilance training courses

 

Should

  • Undertake training on EVWEB to become familiar with application changes
  • Complete testing of existing systems six to three months prior to the new system going live
  • Consider resource and budget implications associated with the implementation of the ISO ICSR standard and supporting the receipt of ICH E2B(R3) messages, particularly concerning the work of IT system developers

Should

  • Ensure that the transition to simplified reporting to EV is communicated to marketing authorisation holders within their territory
  • Prepare a communication plan to keep local stakeholders informed about the switch to  simplified reporting and the process changes related to signal management
TechnologyProcess

Must

  • Upgrade the local pharmacovigilance system to be able to generate and process ICSRs in the ICH E2B(R3) format
  • Ad interim, install a backwards/forwards conversion tool (where applicable)

Should

  • Prepare internal plans in relation to the implementation of the new EudraVigilance system and the resulting changes in electronic reporting, downloading and analysis of data

 

Must

  • Update existing processes:
    • to receive ICSRs reported by marketing authorisation holders and rerouted by EudraVigilance;
    • to stop sending reports from healthcare professionals and patients to marketing authorisation holders;
    • to stop sending ICSRs to WHO UMC;
    • to start reporting of suspected non-serious adverse reactions to EudraVigilance within 90 days of receipt;
    • to comply with the provisions set out in revision 2 of GVP Module VI;
    • to perform signal detection and validation in line with revision 1 of GVP Module IX and the new EVDAS reports and data outputs;
    • to support the submission of validated signals by marketing authorisation holders.

Should

  • Coordinate the transition to the simplified reporting with the new system's implementation and all stakeholders involved
  • Ad interim during the transition, follow the specific nullification (to indicate that a case is no longer valid) process as outlined in the EU ICSR Implementation Guide

 

What should marketing authorisation holders do to prepare for the change?

Activities that marketing authorisation holders must and should do are below.

PeopleInformation

Must

  • Assign specific users the permission to access EVDAS and register those users line with the EudraVigilance registration process
  • Staff to undergo training on:
    • Use of the new ICH E2B(R3) format
    • EVDAS
    • GVP Modules VI (revision 2)
    • GVP Modules IX (revision 1)
    • EudraVigilance Access Policy

Should

  • Undertake training on EVWEB to become familiar with new functionalities and changes
  • Consider resource implications associated with
    the implementation of the ISO ICSR standard and supporting the receipt of R3 messages as well as the operation of a backwards/forwards conversion tool ad interim and where necessary
  • EMA anticipates that new requirements may necessitate an increase in resources, including:
    • meeting the new signal management requirements using EudraVigilance data and screening electronic reaction monitoring reports;
    • the legal requirement to report non-serious cases in EudraVigilance;
    • the mechanism for searching and downloading ICSRs using the ICSR download functionality; of EudraVigilance to obtain access to ICSRs from national competent authorities in the EEA;
    • training of staff

Must

  • Monitor data available in the system and to inform EMA and national competent authorities about safety signals validated to contain sufficient evidence to necessitate further analysis

Should

  • Prepare a communication plan to inform affiliates, contractual partners and other stakeholders about the changes to take place with the launch of the new EudraVigilance system and related process changes

 

TechnologyProcess

Must

  • Configure, where applicable, the local Gateway to support ICH E2B(R3) messages. It is not necessary to replace the software
  • Ad interim, install a backwards/forwards conversion tool if the ICH E2B(R3) format cannot be processed yet locally
  • Upgrade and move to an ICSR ICH E2B(R3) compliant system

Should

  • Prepare for the electronic transmission format based on the ISO ICSR standard
  • Plan for testing of local pharmacovigilance system adaptations

Must

  • Update existing processes:
    • to download ICSRs from national competent authorities in the EEA using the EudraVigilance ICSR download functionality;
    • to stop sending ICSRs to national competent authorities in the EEA;
    • to start reporting of suspected non-serious adverse reactions to EudraVigilance within 90 days of receipt;
    • start reporting of suspected non-serious adverse reactions to EudraVigilance within 90 days of receipt;
    • to comply with the provisions set out in revision 2 of GVP Module VI;
    • to perform signal detection and validation in line with revision 1 of GVP Module IX and the new EVDAS reports and data outputs;
    • to support the submission of validated signals to national competent authorities in the EEA.

Should:

  • Align reporting of ICSRs (for medicinal products authorised in the EEA) occurring within or outside the EEA so that these reports are transmitted only to EudraVigilance in compliance with the pharmacovigilance legislation
  • Ensure that the transition to simplified reporting is coordinated in line with the guidance and communication provided by EMA and NCAs in EEA Member States
What should sponsors of clinical trials do to prepare for the change?

Activities that sponsors of clinical trials must and should do are below.

PeopleInformation

Should

  • Ensure that users of EVWEB  undertake training to become familiar with the new system
  • Plan training for staff six months prior to the implementation of the new system. This should be followed up by regular refresher trainings, at least three months and two weeks before implementation

Should

  • Consider developing a communication plan to ensure that information on changes is circulated internally and partners and inform IT departments of associated IT change requirements
TechnologyProcess

Should

  • Plan to develop systems to support the ICH E2B(R3) format; submissions of SUSARs will be possible in the E2B(R2) format even after the implementation of the new system
  • Configure, where applicable, the local Gateway to support ICH E2B(R3) messages. It is not necessary to replace the software
  • Ensure that modifications to submission systems are configured and tested well in advance of the planned implementation

Should

  • Continue to report SUSARs for clinical trials authorised under Directive 2001/20/EC in accordance with the currently established process
  • Adapt their processes of reporting in line with the new ICH E2B(R3) format, data elements and business rules if they use EVWEB for SUSAR reporting
  • Adapt their business processes in line with the communication and instructions provided on the dedicated Clinical trials in human medicines webpage of the Agency
How can I be informed about the change?

EMA's communication activities will include:

  • general updates to support stakeholders in preparing for IT and business process changes;
  • targeted communications when reaching project milestones.

For information on when project milestones are expected and the corresponding communication activities planned, see:

 

On the new EudraVigilance database, where can I find detailed information and guidance? (Updated July 2017)

ICH provides the basis for the implementation of the ISO ICSR standard. Relevant documents are downloadable from the ICH Electronic Standards for the Transfer of Regulatory Information (ESTRI) website. They are also listed below.

To complement the ICH E2B(R3) implementation guides, EMA has developed a specific EU ICSR implementation guide and supporting documents, including user guides and training material. These documents provide additional information on specific EU regional requirements not provided for in the ICH documentation. They are progressively published when finalised.

ICH implementation guidance

DocumentationDescription
ICH Implementation guide packageSet of documents including the ICH ICSR implementation guide, backwards and forwards compatibility recommendations and element mapping.
ICH E2B(R3) Questions and answersRelevant for technical E2B questions.

EU implementation guidance

DocumentationDescription
EU ICSR implementation guide Rev.1 updatedGuide describing the additional EU-specific requirements to generate a valid ICSR and message acknowledgment to implement EN ISO ICSR in accordance with ICH E2B(R3).
EU ICSR implementation guide business rules spreadsheets  updatedThese spreadsheets include all the ICH E2B(R3) and EU specific business rules in a format to help system developers.
EU backwards forwards conversion element mapping spreadsheetThis document describes the relationship between EU specific data elements in E2B(R3) and E2B(R2). This document is an addition to the ICH backwards-forwards conversion rules. It covers additional EU-specific rules for the conversion back and forth between E2B(R2) and E2B(R3).
EU BFC conversion v.2.2 updatedThe ICH backwards-forwards conversion tool updated to include additional EU-specific data fields.
EU E2B(R3) code listsThe list of codes for EU-specific data fields.
UCUM units for E2B (R3) v1.0 newThe list of valid UCUM units that can be used in the EU for E2B (R3).
EU reference instancesICH reference instances amended to include EU-specific data fields.
EU E2B (R3) testing files  updatedAdditional example instances to be used for testing E2B(R3) transmissions with the enhanced EudraVigilance system.

Revised EudraVigilance access policy

DocumentationDescription
Revised EudraVigilance access policyThe revised EudraVigilance access policy, which governs the level of access different stakeholder groups have to adverse drug reactions reports.
Overview of comments received on 'Draft revision of EudraVigilance access policy for medicines for human use’The comments received on the draft revision of the EudraVigilance access policy during its public consultation between 4 August and 15 September 2014.

Good pharmacovigilance practice (GVP) guidance

DocumentationDescriptionDate available
Revised GVP Module VIThis module addresses the management and reporting of adverse reactions to medicinal products.Q3 2017
Revised GVP Module IXThis module describes the general guidance and requirements on structures and processes involved in signal management and how they are applied in the setting of the EU pharmacovigilance and regulatory network.Q4 2017
On the current EudraVigilance database, where can I find detailed information and guidance?

EMA makes available guidance documents to help stakeholders with using the current EudraVigilance system before the new system goes into production.

Guidance documents

DocumentationDescription
European Union individual case safety report (ICSR) implementation guide
  • This guidance describes the EU-specific requirements to generate a valid ICSR safety and acknowledgment messages in the international format EN ISO ICSR 27953-2:2011 in accordance with ICH E2B(R3) guidance
  • It should be read in conjunction with the ICH E2B(R3) implementation guide and related materials published on the ICH website
Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)
  • This guidance describes the EU-specific requirements to generate a valid ICSR safety and acknowledgment messages in the ICH E2B(R2) format
  • It should be read in conjunction with the ICH E2B(R2) technical specifications and related materials published on the ICH website
Note for guidance on the Electronic Data Interchange (EDI) of individual case safety reports (ICSRs) and medicinal product reports (MRPs) in pharmacovigilance during the pre- and post-authorisation phase in the European Economic Area (EEA)
  • The guidance specifies the technical requirements and the process of transmission of electronic reports and messages through the EudraVigilance Gateway established at EMA and describes the obligations that EDI partners have to adhere to in this process to assure a successful electronic communication
  • It also describes the implications of electronic reporting with regard to the legal reporting compliance as defined in pharmacovigilance legislation, the evaluation steps and the recovery procedures in the event of a communication failure
List of pharmaceutical dosage forms
  • This spreadsheet provides a list of dosage forms used in the EudraVigilance system

Current EudraVigilance access policy

DocumentationDescription
EudraVigilance access policy for medicines for human useThe EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.
Explanatory note: EudraVigilance access policy for medicines for human useThe explanatory note on the EudraVigilance access policy for medicines for human use published in July 2011
Overview of comments received on draft EudraVigilance access policy and implemented amendmentsThe comments received on the draft EudraVigilance access policy during its public consultation and the implemented amendments published in July 2011
Draft EudraVigilance access policy for medicines for human useThe draft EudraVigilance access policy for medicines for human use published in December 2008

ICH implementation guidance

DocumentationDescription
E2B(R2) ICSR specification and related filesTechnical ICH E2B(R2) ICSR message specification and related files
ICH Harmonised Tripartite Guideline - Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements of Transmission of Individual Case Safety Reports E2B(R2)The document provides details of the data elements for transmission of individual case safety reports by identifying and defining the data elements for the transmission of all types of individual case safety reports, regardless of the source and destination
E2B Implementation Working Group - Questions & Answers (R5)This document provides questions and answers on the conventions for the harmonised interpretation of the ICH E2B(R2) guideline and messaging specifications

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