The European Medicines Agency is responsible for implementing the European Union (EU) Telematics strategy. EU Telematics is the collective name for a joint endeavour in the context of the regulation of medicines for human and veterinary use between the European Commission, the European Medicines Agency and national competent authorities (medicines regulatory authorities in Member States). Together, these make up the EU regulatory network.
EU Telematics aims to put in place and maintain common information-technology (IT) services to implement European pharmaceutical policy and legislation. These services should be cost-effective, efficient and interoperable, helping to optimise support to the EU regulatory network in the regulation of medicines for the protection of human and animal health.
The main objectives of EU Telematics are to:
- support and enable efficient working across the EU regulatory network through:
- facilitation of the best use of available resources;
- improvement of the exchange of information between stakeholders;
- improvement in the quality and extent of harmonised information available in support of the work, to disseminate information to stakeholders and to enhance transparency;
- facilitate and promote partnership across the EU regulatory network in the accomplishment of the joint mission in the course of day-to-day operations;
- establish and execute of projects across the EU regulatory network with demonstrated added value in order to ensure protection of public and animal health.
EU Telematics strategy and implementation
The EU Telematics Management Board agreed a new strategy for the future of EU Telematics which was endorsed by EMA Management Board in June 2014 and by Heads of Medicines Agencies (HMA) in July 2014. The EU Telematics strategy2014-2016 was a result of joint work between the members of the network and has been subject to extensive consultation within the Telematics governance structure.
Following consultation with national competent authorities and industry, an EU Telematics strategy and implementation roadmap 2015-2017 was adopted by the EU Telematics Management Board in June 2015 and endorsed by HMA and the EMA Management Board in summer 2015.
The document describes how the vision and strategy for EU Telematics will be delivered through a related set of projects and programmes that address the IT needs arising from European policies and legislation in the area of pharmaceuticals.
Across all the programmes there are common themes, with overall benefits being:
- Improve efficiency in all regulatory procedures by making best use of IT
- Reduce duplication and cost of developing and maintaining local IT systems
- Optimise value of existing IT systems by improving interoperability of IT systems
- Provide a unified way for Industry to interact with regulators in the EU and reduce cost for Industry
- Increase regulatory quality by facilitating sharing of high quality data within the EU and globally
- Meet timely regulatory compliance
The document is intentionally high-level and provides an overall framework. It will be updated periodically to reflect programme advancements and the changing regulatory environment.
The EU Telematics strategy provides an overall framework within which more detailed strategies are developed in specific areas.
The first of these was an IT and data strategy for veterinary medicines that was adopted by the EU Telematics Management Board in May 2014:
The EU Veterinary Medicinal Product database is the first output from this roadmap, providing a publicly accessible database of authorised veterinary medicinal products. It is under development.
The database was launched in March 2015 containing the information already provided by certain Member States into EudraPharm. It is intended to provide information on all veterinary medicinal products authorised in the EU and the European Economic Area (EEA). All Member States are encouraged to provide their information on authorised veterinary medicinal products for inclusion in the database. The information in the database is provided by regulatory authorities of the Member States and by EMA.
The final HMA eSubmission roadmap was adopted by the EU Telematics Management Board on 1 October 2014. It outlines the common, agreed vision for the objectives on eSubmissions in Europe.
An EMA master data management roadmap has been developed following a series of interviews with various stakeholders and outlines a multi-annual EMA programme, which defines a master data management strategy for the use of medicinal product data related to substance, product, organisation and referential (SPOR) data. The initiative aims to optimise and build on the current data governance, business processes and technology platforms in place at EMA, whilst considering wider stakeholder data requirements.
This roadmap will be the starting point for the creation of the EU SPOR roadmap to be developed by the EU International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) Task Force and submitted for endorsement via the Telematics governance including the EMA Management Board and HMA in the coming months.
- European Medicines Agency Master Data Roadmap
- Annex to the European Medicines Agency Master Data Roadmap
Governance of EU Telematics
EU Telematics is governed by the EU Telematics Management Board, which provides the vision for and strategic oversight of the programme. The Board interacts with both the European Medicines Agency's Management Board and the Heads of Medicines Agencies' Management Group and oversees the activities of the IT Directors Group and its subgroup, the IT Directors Executive Committee.
The IT Directors Group in turn oversees the activities of the Telematics Enterprise Architecture Board and project, maintenance and support teams. EU Telematics governance is supported by the Telematics Project Management Office and secretariat.
Each EU Telematics governance group includes representatives of the European Commission, national competent authorities and the Agency. Most representatives are IT specialists. Industry representatives are also involved in Telematics projects when needed.
Full details of the EU Telematics governance structure are available in:
- The joint EU Telematics governance model
- European Union Network Data Board: Terms of Reference
- Telematics Enterprise Architecture Board: Terms of reference
- Nominations to the EU Telematics governance bodies
- EU Telematics Management Board: Terms of reference
- IT Directors Group: List of nominated members
- IT Directors Group: Terms of reference
EU Telematics governance's ambition is to:
- foster collaboration across the EU regulatory network by setting up and maintaining a coalition of willing partners to develop, implement and maintain common IT services;
- maximise efficiency in communication around the development and operation of IT for the EU regulatory network;
- become a platform for all ongoing IT activities for the EU regulatory network over time.
In achieving this ambition, it intends to promote collaboration in IT development and operations and support well-informed decision-making at the appropriate levels.
Components of EU Telematics
The following systems make up the EU Telematics programme:
- EudraCT: a database containing registrations of clinical trials;
- EudraGMDP: support for regulatory activities in the areas of manufacturing and distribution;
- EudraLink: the European medicines regulatory network’s secure file-transfer system used for exchanging information for regulatory purposes;
- EudraNet: a private electronic network linking the members of the European medicines regulatory network and the Agency;
- EudraPharm: a database of authorised medicinal products;
- EU Veterinary Medicinal Product Database: a database of authorised veterinary medicinal products;
- EudraVigilance: a system monitoring the post-authorisation safety of medicines through safety reports;
- EudraVigilance Veterinary: a network and database management system for the exchange, processing, and evaluation of suspected adverse events related to veterinary medicines;
- European Review System (EURS): a system that enables regulatory authorities in Member States and the Agency to receive, validate and store marketing-authorisation applications and to make them available for review;
- EU Telematics Controlled Terms (EUTCT): a central repository and publication system for controlled term lists used in the European medicines regulatory network;
- Standards for Electronic Submission (eSubmission): electronic marketing-authorisation applications.
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