|
Février
2001
Eudranet
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
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
|
 |
|
| Lexique |
|
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
|
|
