Eudranet

Esteban Gonzalez- Juarros,
Project Officer d’EudraNet

"EudraNet va renforce son rôle de portail de communication sécurisée entre les agences et les firmes pharmaceutiques.""

by Corinne RADAL

19 february 2001
following and end (3/3)

How did pharmaceutical firms receive EudraNet? Do they use it and how ?

Pharmaceutical companies consider EudraNet as a relevant element to facilitate the operation of regulatory procedures, from marketing application to product supervision. While full applications will be submitted electronically on physical media such as CD-ROM or DVD, other submissions such as variations and responses to requests for additional information may be transmitted by means of EudraSafe and made available to concerned member states over EudraNet. We plan to notify electronically by means of EudraSafe to the sponsors the authorisation of medicinal products carried out through the centralised procedure.

Companies are using EudraSafe to electronically transmit Individual Case Safety Reports in the context of the Joint Pharmacovigilance Pilot, and the EudraVigilance pharmacovigilance system is available to Members States through EudraNet.

The Commission and EMEA web sites in pharmaceuticals are hosted and made available to companies and the public through EudraNet. The steady increase in the number of visitors demonstrate the relevant of the regulatory, scientific and administrative information published from these sites including Community legislation, guidelines, centrally authorised products, contacts, studies and documents for consultation. 

Do you think that the electronic submission of marketing authorisations will be a standard procedure in Europe ?

Within the ICH M2 Expert Working Group, regulators and industry from EU, US and Japan collaborate on the definition of the guideline for the electronic Common Technical Document.

This action is supported in Europe by the eSubmission working group composed of delegates from the European and national agencies. The eCTD guideline must be complemented regionally to cope with the non-harmonised parts of the dossier, such as Module 1.

As a result, companies will be able to submit applications electronically with comparable contents and formats to the competent authorities of the ICH regions.

How do you consider the future of EudraNet? Have you already thought about new developments ?

EudraNet constitutes a model of technical infrastructure and organisational framework supporting co-operation between governments in Europe and collaboration between the European public sector, as a whole, and industry. The need to easily and rapidly communicate and share information in order to keep mutually informed and collaboratively take decisions will become even more apparent after the enlargement.

I envisage the EudraNet model being implemented in other market sectors.

EudraNet will certainly expand geographically. Nowadays it covers the countries of the European Union, plus Norway and Iceland. Soon, Liechtenstein will also be connected. The authorities from the Central and Eastern European countries have often indicated that EudraNet is a key tool to facilitate the enlargement and the operation of Community procedures in an enlarged EU. An operational plan for the extension of EudraNet to these countries has been prepared and is ready to be applied.

The increasing number of users and usage of the network will soon make necessary an upgrade of the bandwidth. This upgrade will be done taking into account the new applications that are being introduced and the new services that have already been tested and, very especially, desktop videoconference.

EudraNet will consolidate its role as secure communication gateway between agencies and pharmaceutical companies. I foresee that, for every medicinal product, early in the process of research, a secure communication channel between one professional from the company and one officer from the reference agency will be established, allowing secure, fast and trackable communication all along the life cycle of the product.

Give your opinion.

19 february 2001