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Février 2001


Esteban Gonzalez- Juarros,
Project Officer d’EudraNet

"EudraNet will consolidate its role as secure communication gateway between agencies and pharmaceutical companies."

by Corinne RADAL

19 february 2001

Lire l'interview en Français
Read it in French


How was born the concept of EudraNet? What is its purpose and objectives ?

The idea of a telecommunication network between European agencies in pharmaceuticals was conceived by DG Industry (now DG Enterprise) and the Joint Research Centre, and dates back to the late eighties in relation

to the Transparency Directive and the ECPHIN project, which aimed to build a database of medical and pricing information for pharmaceuticals with information provided electronically by the national competent authorities (through X25 lines at the time). This pioneer concept was further elaborated in relation to pharmacovigilance and enshrined in the regulation constituting the European Agency and the Community procedures.

Currently, EudraNet supports all Community procedures and collaborative business processes in pharmaceuticals -those carried out between the European Commission, the European Agency and the national agencies, and those others requiring co-operation between regulators and industry-.

It is a central instrument within the Community telematics policy in pharmaceuticals that runs across four lines of action:

  • co-operation between regulatory agencies,
  • collaboration between regulators and industry,
  • dissemination of information to the public,
  • internal business processes.

EudraNet services are structured at three levels: linking, communication and application.

  • The EudraNet infrastructure links the
    regulatory agencies local networks. It is built upon Testa, a network backbone financed by the IDA Programme. It provides secure and reliable electronic communication to competent authorities responsible for medicines for human and veterinary use in Europe.
  • The communication services available within
    EudraNet include secure email (EudraMail), collaborative group work environment (EudraRoom) and secure communication gateway with correspondents over the Internet (EudraSafe).
  • EudraNet is also the platform that hosts and enables the operation of shared databases and tracking systems on specific domains. This is the case of EudraTrack, that registers information on the mutual recognition procedures, Vetmp, that lists veterinary products authorised, and Xeddra, that allows browsing of Meddra, Veddra, ATC, ATC-Vet and other data dictionaries.

There are the ongoing actions to make available common repositories on Individual Case Safety Reports, Medicinal Products and Manufactures.
Equally important, EudraNet hosts the Commission and EMEA Web sites in pharmaceuticals, available through the eudra portal (www.eudra.org).
This has enormously incremented the quantity and quality of regulatory, scientific and administrative information available to the public in pharmaceuticals.


19 february 2001

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EEA : European Economic Area

CPMP : Committee for Proprietary Medicinal Products

CVMP : Committee for Veterinary Medicinal Products

DG : Directorate General

ECPHIN : European Community Pharmaceutical Information Network

JRC : Joint Research Centre

IDA : Interchange of Data between Administrations.

Vetmp : Veterinary Medicinal Products

Meddra : Medical Dictionary for Regulatory Activities

Veddra : Veterinary Dictionary for Regulatory Activities

ATC : Anatomical Therapeutic Chemical

ATC-Vet : Anatomical Therapeutic Chemical vétérinaire

VICH : International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products

EC : European Community

ICH M2 : International Cooperation on Harmonisation  Multi-disciplinary Group 2

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