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Telematic systems for the eu pharmaceutical regulatory activity (ETOMEP)

Objective

Specific Objectives

The objectives of the project are:
Define and deliver to the EU pharmaceutical regulatory sector a suite of pilot innovative systems:
- Eudranet2;
- Unified Tracking System;
- Medicine Information Network 1 (Mine1).

These systems will improve the overall efficiency of the EU regulatory process and will contribute to the opening of the EU regulatory environment to CEEC regulatory authorities, the health care professionals, consumers and consumers associations.
Planned Deliverables

Specific deliverables to DGs will cover the following:
- Eudranet2, a pilot telematic service including a VPN (Virtual Private Network) connecting EMEA, DG ENTR, JRC and the National Agencies, a PKI (Public Key Infrastructure) and desktop video-conferencing;
- Unified Tracking System, a pilot telematic application including a common tracking component for the centralised and mutual recognition procedures with customised productivity modules for the EMEA and for the National Agencies, a European Product Index system and a pilot for the MINE system.

Summary of 2001 deliverables
- MINE 1 prototype:
- design and implementation of the web-based application;
- design and functional specification of the final web architecture;
- analysis of existing data harmonisation process;
- set-up of user communities, improvement of the user interface;
- Unified Tracking System (UTS): specification and implementation of the EU standards in the pharmaceutical field, specification and design of the primary tracking system;
- EudraNet: implementation of EudraSafe; configuration of the firewall;
design and initial set-up of the Eudranet 2 laboratory, piloting the VPN, including the certification authority, registration authority and directory services (PKI).

Deliverables 2002
- Complete transfer of activities related to EUDRANET from JRC to EMEA;
- Definition of the new MINE 1 and overall informatics system together with DG ENTR and EMEA;
- Technology transfer of EUDRATRACK activities to be implemented through the support of an external company.
Summary of the project

The proposed activity programme has been prepared following consultation with the EMEA, DG ENTR, pharmaceutical industry and consumer associations, taking into account the R&D nature of the JRC.

Within these guidelines the following research and development activity will be undertaken:
- Communication systems for regulatory tasks, allowing the tracking and analysis of the marketing authorisation of pharmaceuticals for human and veterinary use;
- Crypto-security methods and strategies for ensuring secure access to information on safety and efficacy for consumers and secure transfer of information for the regulatory process;
- Support to the marketing authorisation regulatory processes involving several actors (e.g. evaluators, administrators and decision makers).

These activities foresee the implementation of high quality and trustworthy information management systems and services to support DGs, European agencies, Member State authorities, consumer organisations and industries and, ultimately, the European citizens.

Rationale

While the basic objectives of the Single Market policy in the pharmaceutical regulatory system established in the Council Regulation (EEC) N. 2309/93 have been achieved, some important task have not been undertaken yet. These tasks are related to the EU Health Policy, the Consumer Policy, the Enlargement of the EU to CEEC, the revision of the mandate of the European Medicine Evaluation Agency and to the pressing requirements from industry, consumers and health profession which require a notable upgrade of the current scientific systems currently supporting the implementation and monitoring of the pharmaceutical regulatory policy. In particular these requirements are related to harmonisation and validation of measurements methods, development of information systems delivering official information on the quality, efficacy and safety of medicines and pilot implementations of innovative telematic systems and applications.

Funding Scheme

JRC - Joint Research Centre research

Coordinator

Institute for Health and Consumer Protection
Address

Ispra
Italy