EudraVigilance

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EudraVigilance is the European Union (EU) regulatory network system for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) manages the system on behalf of the EU medicines regulatory network. The revised EU legislation on pharmacovigilance updated the legal framework for reporting and analysing suspected adverse reactions in EudraVigilance, to deliver better health protection. In 2015 EMA launched a project to deliver an enhanced EudraVigilance system in 2017.

EudraVigilance supports the safety monitoring and safe and effective use of medicines by facilitating:

  • the electronic exchange of suspected adverse drug reaction reports, known as individual case safety reports (ICSRs), between EMA, national competent authorities, marketing-authorisation holders and sponsors of clinical trials in the European Economic Area (EEA);
  • the early detection and evaluation of possible safety signals for human medicines;
  • better product labelling.

The system is in full compliance with the specifications of the International Council 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

EMA publishes data from Eudravigilance in the European database of suspected adverse drug reaction reports.

The public website allows users to view the number of serious individual suspected-side-effect cases submitted spontaneously to EudraVigilance for each centrally authorised medicine. Users can sort reports by age group, sex, type of suspected side effect and outcome.

As of October 2014, EMA has also been publishing reports for common drug substances contained in nationally authorised medicines on this public website.

The EudraVigilance access policy governs the level of access different stakeholder groups have to the adverse drug reactions reports. 

Revised EudraVigilance access policy

EMA has revised the EudraVigilance access policy ahead of implementing the new EudraVigilance system in 2017. This revised access policy was adopted by the EMA Management Board in December 2015 and will enter into force six months after the Management Board announces that the EudraVigilance database has achieved full functionality, based on an independent audit report. For more information, see:

Analysis of data

EMA and national competent authorities are currently responsible for regularly analysing EudraVigilance data in order to detect safety signals. Once the new EudraVigilance system is implemented in 2017, marketing-authorisation holders will also be legally obliged to monitor the EudraVigilance data they have access to and to report validated signals to EMA and national competent authorities. 

The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates the safety signals detected in EudraVigilance and may recommend regulatory action as a result.

For more information on how EMA interprets information on reported cases of suspected adverse reactions, see:

Enhancement of the EudraVigilance system

The updated pharmacovigilance legislation brought about significant changes to electronic reporting requirements for suspected adverse reactions in order to support better safety monitoring for medicines and a more efficient system for stakeholders. The new legislation requires:

  • EMA to enhance EudraVigilance to deliver simplified reporting, better quality data and improved searching, analysis and tracking functionalities. These improvements will help to detect new or changing safety issues earlier and to take necessary action sooner;
  • 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;
  • the use of international data standards, including the International Organization for the Standardization ICH E2B(R2) data structure for ICSRs;
  • a change from a national to a centralised system for reporting ICSRs in the EU, with EMA receiving ICSRs and forwarding cases to the national competent authorities concerned;
  • the reporting of non-serious cases of suspected adverse drug reactions to EudraVigilance.

EMA has launched a project to deliver the new EudraVigilance system by 2017. The new system will have several significant benefits, including:

  • improved quality and completeness of the ICSR data allowing better searchability and more efficient data analysis;
  • enhanced scalability of the EudraVigilance system to cope with an expected increased number of ICSRs, due to the new requirement to report non-serious cases to EudraVigilance.
  • improved detection of new or changing safety issues by enhancing signal-detection and data-analysis tools to support safety monitoring directly by Member States and marketing-authorisation holders. This will enable rapid action to protect public health;
  • reduction in duplication of efforts by introducing the centralised reporting of ICSRs to EudraVigilance and the re-routing of ISCRs to Member States. Marketing-authorisation holders will no longer provide ICSRs to national competent authorities and must submit these to EudraVigilance only;
  • enhanced collaboration between EMA and the World Health Organization (WHO), as EMA will provide data to the WHO Uppsala Monitoring Centre directly from Eudravigilance, meaning that individual Member States will 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 implementing in the EudraVigilance system as well as business process changes required to work with the new system:

Concerned national competent authorities, marketing-authorisation holders and sponsors of clinical trials should use this document as a starting point to develop their own internal implementation plans prior to the new system going live in 2017.


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Technical and business process changes: questions and answers

The questions and answers 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.

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

  • configuring EudraVigilance Gateway, the secure electronic communication tool to exchange ICSRs, to accept ICH E2B(R2) and (R3) files.
  • adapting the EudraVigilance database management systemto support the storage of data submitted with the new ISO ICH ICSR format. All existing ICH E2B(R2) ICSR data will be migrated to the new ISO ICH ICSR format;
  • rebuilding the EVWEB reporting application, the web interface tool for the electronic reporting of ICSRs, using a new technology and design to support data entry and visualisation of ICSRs in the ISO ICSR format;
  • introducing new functionalities in the EudraVigilance data analysis system (EVDAS), including the European database of suspected adverse drug reaction reports, the tool to analyse data and support signal management activities. The new functionalities will support marketing-authorisation holders and national competent authorities in fulfilling their pharmacovigilance obligations.

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

  • the EudraVigilance re-routing rules engine to allow national competent authorities to set their re-routing preferences for ICSRs;
  • the 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.

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

How will changes to the EudraVigilance affect business processes?

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 centralised 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 and 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 updated 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 centralised 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:

  • undergo training for data submission in the new format (R3) and for the implementation of the new data analysis tools (EVDAS).

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 new standard and supporting the receipt of R3 messages. This concerns the work of IT system developers in particular.

Should:

  • report EEA non-serious cases to EudraVigilance within 90 days of receipt ;
  • report seriousness of cases at event rather than at case level. This means reporting the seriousness of each individual event separately within a case. If any event within a case is designated as serious, the whole case will be considered serious;
  • review retransmitted nullification requests (a process to indicate that a case is no longer valid). If the request is for a valid reason, the national competent authority should submit a nullification for the case they have previously submitted to EudraVigilance;
  • ensure that transition to centralised reporting is communicated to marketing-authorisation holders within their territory.
TechnologyProcess

Must:

  • upgrade and move to R3 compliant systems (no deadline yet established).
  • introduce configuration changes to support E2B(R3) when using EudraVigilance Gateway. It is not necessary to completely replace the software;
  • implement the new version of the EVWEB application, which will only support E2B(R3).

Should:

  • prepare internal plans for the implementation of the new EudraVigilance system and the resulting changes in reporting, downloading and analysis of data.

Must:

  • update existing processes for rerouting information to marketing-authorisation holders and the WHO.
  • adapt own business processes to screen new aggregated data made available by EMA, including pharmacovigilance and Article 57 data;
  • update existing data analysis processes;
  • implement a new process to support the submission of signals by marketing-authorisation holders.
  • change standards and processes according to E2B R3 and the pharmacovigilance legislation.

Should:

  • be aware of new ICSR submission processes in the EEA:
    • Marketing-authorisation holders will submit ICSRs to EudraVigilance only.
    • EMA will submit cases to the WHO's Uppsala Monitoring Center through EudraVigilance.
  • coordinate the transition to centralised reporting with the new system's implementation.
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 the EVDAS system, EVWEB and the secure area of EudraVigilance;
  • ensure that staff undergo training for data submission in the new format (R3):
    • Gateway users must review EMA guidance on new configuration.
    • EVWEB users must undergo training on new application.

Should:

  • undertake training on EVWEB to become familiar with application changes;
  • consider resource and budget implications associated with the implementation of the new standard and supporting the receipt of R3 messages. EMA foresees that new requirements may necessitate an increase in resources, including:
    • meeting the new signal detection requirement, using EudraVigilance data and screening electronic reaction monitoring reports.
    • the legal requirement to report non-serious cases in EudraVigilance;
    • logging, searching and downloading activities. The mechanism for companies to access adverse drug reaction cases in EudraVigilance is manual.

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:

  • report EEA non-serious cases to EudraVigilance within 90 days of receipt in order to meet reporting obligations;
  • report seriousness of cases at event rather than at case level. This means reporting the seriousness of each individual event separately within a case. If any event within a case is designated as serious, the whole case will be considered serious.
TechnologyProcess

Must:

  • upgrade and move to R3 compliant systems (no deadline yet established);
  • introduce configuration changes to support E2B(R3) when using EudraVigilance Gateway. It is not necessary to completely replace the software;
  • implement the new version of the EVWEB application, which will be updated to only support E2B(R3).
  • have systems in place to accept new E2B R3 format messages as of the second quarter of 2017.

Must:

  • establish a new process to retrieve data from EudraVigilance directly. National competent authorities and EMA will no longer be required to re-route information when centralised reporting comes into effect.
  • discuss and consult on new process for validating signals during the first revision of the good pharmacovigilance practices Module IX on signal management;
  • change current processes in line with the new functionalities in EVDAS to be able to carry out data analysis activities;
  • change business processes for single data submission in EudraVigilance.

Should:

  • submit ICSRs to EudraVigilance only within the EEA;
  • coordinate the transition to centralised reporting with the new system's implementation.
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:

  • be aware that only electronic submissions of suspected unexpected serious adverse reactions (SUSARs) to the EudraVigilance system will be considered as compliant with legal obligations;
  • consider developing a communication plan to ensure that information on changes is circulated internally and inform IT departments of associated IT change requirements.
TechnologyProcess

Should:

  • plan to develop systems to support the new reporting format (R3). However, submission of SUSARs will be possible in the E2B(R2) format even after the implementation of the new system;
  • implement changes to support the processing of E2B(R3) messages, if using an electronic gateway solution configuration;
  • ensure that modifications to submission systems are configured and tested well in advance of the planned implementation.

Should:

  • submit SUSARs through the centralised reporting to EudraVigilance and put in place a set of business rules for the automated forwarding of these SUSARs to the national competent authority requesting them.
    • small organisations unable to create electronic submissions and have no resources to use EVWEB can still report SUSARs directly to national competent authorities. EMA will develop a new standard web-based structured form to help non-commercial sponsors and small organisations to support SUSARs.
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:

What type of training will EMA offer?

EMA will offer targeted training in the form of user manuals, information videos and online and face-to-face meetings. These will explain the modifications to the EudraVigilance system and how to use the system effectively.

EMA has made available a detailed training plan. EMA strongly advises users to familiarise themselves with training available on the use of EudraVigilance and EVDAS.

For more information, see EudraVigilance training.

Where can I find detailed information and guidance on the new EudraVigilance database?

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 ICH implementation guides, EMA has developed a specific EU implementation guidance as well as associated supporting documents, including user guides, training material and guidelines. These documents provide additional information on specific EU regional requirements not provided in the ICH documentation. They are progressively published when finalised.

ICH implementation guidance

DocumentationDescription
ICH Implementation guide packageA set of documents including the ICH ICSR implementation guide, backwards and forwards compatibility recommendations and element mapping.
ICH E2B(R3) Questions and answersA question-and-answer document relevant for technical E2B questions.

EU implementation guidance

DocumentationDescription
EU ICSR Implementation GuideA guide 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 spreadsheetThis spreadsheet includes 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).
Draft EU BFC conversionThe 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.
EU reference instancesICH reference instances amended to include EU-specific data fields.
EU example instancesAdditional example instances to be used for testing E2B(R3) transmissions to the EudraVigilance system.

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 addressees the management and reporting of adverse reactions to medicinal products.To be confirmed
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.To be confirmed

Training materials

DocumentationDescriptionDate available
EVWEB and ICSR download tool training materialTraining material for existing or new users to use EVWEB and ICSR download tool.To be confirmed 
EVDAS training materialTraining material for existing or new users to use the EudraVigilance data analysis system.To be confirmed 
Where can I find detailed information and guidance on the current EudraVigilance database?

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 guideThis 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. This guidance 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. This guidance should be read in conjunction with the ICH E2B(R2) technical specifications and related materials published on the ICH website.

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.

 

Who can I contact for further support?

EMA operates service desks to assist marketing-authorisation holders and national competent authorities in using EudraVigilance in the EEA Member States. The working language of the service desk is English. The working hours are the same as the EMA business hours.

Depending on your type of enquiry, contact:

EudraVigilance Registration

E-mail: eudravigilanceregistration@ema.europa.eu
Tel.: +44 (0) 20 3660 7523

EMA IT Service Desk (For support with EudraVigilance and EMA gateway/webclient)

Tel.: +44 (0)20 3660 8520 (for urgent technical matters)

Ask EMA(For support on Pharmacovigilance, general questions and access to documents)

Detailed guidance on how to submit a query can be found in the EudraVigilance support guide.

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