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EUDRANET: European Telecommunication Network in Pharmaceuticals (EMEA)

EUDRANET
    Europe is the world’s largest pharmaceutical producer. For this reason, the pharmaceutical sector is extensively regulated with the dual objective of protecting public health and meeting the demands of the Internal Market. EUDRANET helps pharmaceutical authorities in all stages of their business processes through its successful telecommunications network and blend of network services.

Last update: 02/2004

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What is EUDRANET?
Objectives
How does it work?
Achievements
Who benefits?
The role of IDABC
Technical information
Documentation

What is EUDRANET?

EUDRANET is a European human and veterinary pharmaceuticals telecommunication network offering Information and Communication Technology (ICT) services that allows scientific experts, those working on pharmaceutical business processes and policy makers to have a secure and well structured electronic environment to 'meet', exchange information and work together on a pan-European scale.

Although managed by the European Medicines Evaluation Agency (EMEA), the Eudra 'family' of applications (such as EUDRAVIGILANCE and EudraTrack) comes under the overall responsibility of the Pharmaceuticals and Cosmetics Unit within the European Commission's DG Enterprise. These applications are provided in collaboration with the EMEA and the national authorities responsible for pharmaceuticals, which make 28 organisations in total.

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Objectives

EUDRANET aims to provide appropriate secure services for inter-Administration data interchange and for exchanges between Administrations and industry.

  • One of EUDRANET's main objectives is to enable the electronic exchange of information between the European Commission, EMEA and the national regulatory authorities responsible for pharmaceuticals across the EU Member States. It aims to achieve this through the use of TESTA as its backbone.
  • A second key objective is to provide a service for secure and managed communication over the Internet between European Administrations and pharmaceutical companies. This has been achieved through the implementation of EudraLink, a software tool designed to facilitate the secure transmission of information or documents between the EU Member States, the European Commission and the pharmaceutical industry. Thanks to EudraLink, elements of the marketing authorisation procedures can now be carried out over the Internet. EudraLink seeks to ensure the confidential and rapid granting of these authorisations.
  • Thirdly, EUDRANET exists to host and provide access to Community databases in pharmaceuticals. This includes the European Experts Database and Pharmacovigilance database (EUDRAVIGILANCE).
  • Finally, and most importantly, EUDRANET aims to provide a collaborative group work environment and business cooperation tools such as desktop video conference.

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How does it work?

Resting on the TESTA backbone infrastructure provided by the IDABC Programme, EUDRANET acts as an electronic platform, bringing together a wide range of functions and activities which facilitate collaborative pharmaceutical business processes. These processes include:

  • The submission and evaluation of marketing authorisation applications by pharmaceutical companies;
  • The pharmacovigilance of products on the market to ensure the maintenance of high standards of quality as well as adhering to European national and regional regulations;
  • The dissemination of relevant information to industry, scientific experts and regulators.

The implementation, operation, monitoring, maintenance and development of EUDRANET services enable this efficient collaboration. These consist of:

  • EUDRANET's network services: e-mail, directories, web services, document repositories, cooperative group work, discussion fora, desktop video
  • Conferences, access to common databases and the hosting of public websites (750 functional e-mail addresses).
  • EUDRANET application services: Eudra website of the European Commission in pharmaceuticals (which is also available to the public), the Experts database, functional mailboxes, the EUDRAVIGILANCE database and EudraTrack.
  • Support services: Helpdesk and security - support to Certification Authority and digital signatures.

In addition, EudraLink provides a secure mechanism for document transfer with the pharmaceutical industry. EMEA intends, in the near future, to implement a pilot PKI to ensure authentication and the protection of information exchanges between the pharmaceutical industry, the national regulators and EMEA.

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Achievements

  • Since coming fully online in 1998 EUDRANET has been used on a daily basis by many Community committees (e.g. Committee for Human Medical Products, Committee for Veterinary Medicinal Products) and working groups (ICH M2 ESTRI Working Group) in an increasing number of scientific and regulatory fields. In 2000, it was also extended to Norway and Iceland.
  • EUDRANET has had a profound influence on the way that regulatory business is conducted between national authorities and the EMEA. Many business procedures have now been adapted or converted to the electronic data interchange framework, promoting the rapid and efficient flow of information.
  • The relevant authorities from various Acceding and Candidate Countries have also requested connection to EUDRANET. An implementation plan for this extension has been produced and the legal possibilities are currently being evaluated.

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Who benefits?

Public Administrations: EMEA, EU Regulatory Authorities and the European Commission. EUDRANET has improved the dissemination of information related to medicinal products as well as the transparency of the procedures, thereby enhancing the speed and efficiency of decision-making in this area and strengthening the protection of confidential information.

Businesses: With the use of EudraLink, pharmaceutical companies are now able to transmit information electronically in an entirely secure manner, ensuring the precision and harmonisation of the information transmitted and speeding up authorisation processes. EUDRANET in fact contributes to establishing a regulatory and legislative framework that favours the competitiveness of European industry.

Citizens: Citizens in the EU Member States and Acceding Candidate Countries also benefit from access to the specialised websites supported by EMEA. One of the key aims of the EMEA is to assure a high level of public health protection, notably by making safe, innovative products available to patients as quickly as possible. Citizens now have access to websites whose content has benefited from increased supervision of the market through the strengthening of inspection procedures and of pharmacovigilance.

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The role of IDABC

The IDA Programme has financed EUDRANET over a number of years. In addition, EUDRANET was developed in line with the IDABC Architecture Guidelines and uses the TESTA network as its backbone infrastructure for exchanges between the Administrations. EMEA has taken over the responsibility for managing and providing operational support for EUDRANET since 1st January 2003.

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Technical information

Project start date

1997

Project completion date

2002

Project status

Implementation

IDA budget

2,983,000

Responsible service

European Medicines Evaluation Agency

Project coordinator

David Drakeford

Contact

idabc@ec.europa.eu

Countries involved

All EU Member States, Acceding and Candidate countries

Public website

http://pharmacos.eudra.org/
http://www.emea.europa.eu/

Background documents

COM(2002) 735 final - 10.12.2002

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Documentation:


Global implementation plan
 EUDRANET GIP - April 2000 (PDF)
EnglishPDF[1248 Kb]

 

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