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 European medicines 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 strategy 2014–2016 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:
EMA has published an extension to the EU Telematics strategy and implementation roadmap to cover the period 2018–2019:
This will guide ongoing Telematics developments until the European medicines regulatory network develops a new EU Telematics strategy and implementation roadmap for 2020–2025.
The documents 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 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 current HMA eSubmission roadmap was adopted by the EU Telematics Management Board and endorsed by HMA in February 2017. 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.
- European Medicines Agency Master Data Roadmap
- Annex to the European Medicines Agency Master Data Roadmap
This roadmap is aligned with the approach to implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP), known as the ISO IDMP standards.
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 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 European Union DataBoard, the Telematics Enterprise Architecture Board, the Telematics Change Management Board and projects' governance.
EU Telematics governance is supported by the Telematics Office.
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
- Nominations to the EU Telematics governance bodies
- EU Telematics Management Board: Terms of reference
- European Union Network Data Board: Terms of Reference
- Telematics Enterprise Architecture Board: Terms of reference
- IT Directors Group: Terms of reference
- IT Directors Group: List of nominated members
- Adopted terms of reference (ToR) of the Telematics Change Management Board (CMB) and its key user groups
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 PDF image below shows the EU Telematics systems and services currently in operation.