Last update: 02/2004
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What is EUDRAVIGILANCE?
Objectives
How does it work?
Achievements
Who benefits?
The role of IDABC
Technical information
Documentation
What is EUDRAVIGILANCE?
EUDRAVIGILANCE is the new pan-European data-processing network and database management system for the exchange, processing and evaluation of adverse drug reactions that may result following the use of one or several medicinal products. Particularly it is designed for the electronic transmission of Individual Case Safety Reports (ICSRs) related to medicinal products authorised in the Community plus Iceland, Liechtenstein and Norway.
The reporting of such adverse drug reactions is defined in EU legislation - Council Regulation EEC/2309/93, Directive 75/319/EEC and Commission Regulation 540/95. The ongoing supervision of the safety in use of medicines is described as pharmacovigilance.
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Objectives
The objective of EUDRAVIGILANCE is to support pharmacovigilance activities and responsibilities, which are shared between marketing authorisation holders and Competent Authorities in the EEA such as the Irish Medicines Board in Ireland, the Bundesministerium für Gesundheit und Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin in Germany and the Instituto Nacional da Farmacia e do Medicamento in Portugal. It also aims to improve pharmacovigilance on a European scale, providing more consistent and detailed data and faster access to the relevant information to the above authorities.
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How does it work?
The EUDRAVIGILANCE tool is implemented according to requirements mainly based on Community legislation and the results of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) between the European Union, the United States and Japan.
The ultimate goal is that Competent Authorities of Member States as well as Iceland, Liechtenstein, Norway and pharmaceutical companies extract ICSR data from their locally established pharmacovigilance database and transmit this data electronically in the internationally agreed format to one or many receivers, where the information can be automatically processed and evaluated.
In order to do that, EUDRAVIGILANCE works through the following main functional components:
- The EUDRAVIGILANCE Gateway provides a single point of contact between the parties for the secure transmission of ICSRs in the European Union. It allows the pharmaceutical industry to report to a common reporting point within the European Union from where the transactions are re-routed to the addressed Competent Authorities and the EMEA (and vice-versa);
- The EUDRAVIGILANCE Database Management System (DBMS) is a web-based information system designed to handle the safety report information, such as acknowledgement message exchange, routing and loading mechanisms, query mechanisms, the guided ICSR creation procedure, the user management and security mechanisms. The DBMS is offering currently remote access to administrative and scientific users in the European Commission, the EMEA and the Competent Authorities via the established secure network EUDRANET.
- The EUDRAVIGILANCE Standard Terminology (the internationally agreed medical terminology) is designed to support the classification, retrieval, presentation and communication of medical information, with the main focus on the Medical Dictionary for Regulatory Activities (MedDRA) and a Medicinal Product Dictionary. Strict data standardisation is a precondition for a fully automated data transfer.
The data collected by EUDRAVIGILANCE is currently only accessible to Competent Authorities in the EEA. The new website, accessible by the general public, is intended to provide the user with an overview of the legal and technical requirements for the development and implementation of EUDRAVIGILANCE in the European Union. In addition, the specifications and user guidance for providing the EMEA with structured information on medicinal products authorised within and outside the Community are available online.
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Achievements
- After a pilot phase was started in 1999, the implementation of the electronic transmission of ICSRs in the European Union began in December 2001.
- EUDRAVIGILANCE acts as a central access point to pharmacovigilance data collected from within and outside the EEA, and reported electronically to the EMEA.
- It is a crucial component that for the first time allows all Competent Authorities in the EEA to share data on serious adverse drug reactions.
- It provides the necessary evaluation tools to support the supervision of the use of medicinal products.
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Who benefits?
Citizens: EUDRAVIGILANCE contributes to strengthening the protection of public health at EU- and national levels.
Public Administrations and Businesses: EUDRAVIGILANCE work benefits public administrations and businesses in the EEA. The implementation of the ICH standards by all parties involved, and with the support of EUDRAVIGILANCE, will result in the replacement of paper reporting by a more efficient and rapid electronic exchange of information.
Policy makers: Advanced and coordinated notice of potential problems that may indicate a need for regulatory action by the relevant authorities at European or national level, in particular in relation to public and animal health, will accelerate decision-making and lead to more effective actions.
All stakeholders can concentrate their efforts in providing better supervision of the safety of medicinal products thanks to the more rapid exchange of information and the automated processing of data ensured by EUDRAVIGILANCE.
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The role of IDABC
IDABC co-financed the development of the EUDRAVIGILANCE system which makes use of TESTA to support the connection to the application.
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Technical information
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Documentation: |
Print
EUDRAWATCH GIP - May 2000 (PDF)
