Regulatory science research

The European Medicines Agency plays an important role in the innovation and availability of medicines for human and veterinary use through its support to research activities within the European Union (EU) and beyond. In its role in the EU's regulation of medicines, the Agency is in a unique position to contribute to scientific debate by providing experience and expertise in areas related to medicine development and medicine safety.

The Agency works across a wide number of topics and with a broad range of stakeholders, from research institutes, universities and public-private initiatives to the European Commission and EU Member States. Activities range from acting as the secretariat for multipartner networks to membership of pan-European and international research projects.

All of the Agency's work aims to improve the science and process of medicines regulation to foster the development of medicines for unmet medical needs, and to optimise the surveillance and management of medicines on the EU market.

The Agency's road map to 2015 and work programmes underpin the Agency's activities in this area, as part of its mission to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. As part of this aim, it is important for the Agency to be aware of the latest scientific knowledge and methodologies and to actively support science in relevant areas.

The Agency also supports the overarching aims of the EU framework programme for research and innovation.

Also on this topic

• Regulatory science research needs
• Support to research
• Benefit-risk methodology

Involvement of the Agency in research activities

The Agency has targeted engagement with academia, learned societies and research groups in a range of areas, where they enable the Agency to move forward in its mission. These areas include:

• providing a forum for discussion and debate in the committees and working parties;
• organising scientific workshops;
• participating in scientific conferences in a focused manner;
• providing experts to steering committees of research projects and boards of learned societies;
• establishing and supporting networks of excellence, such as the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA);
• engaging in research initiatives of other European or international health bodies, including the European Centre for Disease Prevention and Control (ECDC), the World Health Organization (WHO) and the United States Food and Drug Administration (FDA);
• performing literature reviews and database studies in relation to the evaluation of medicines;
• analysing in-house data;
• advising on policies and identifying research priorities for public or part-public funding programmes;
• launching in-house initiatives on topics of interest in relation to regulatory science, such as the project on benefit-risk methodology;
• coordinating or actively participating in externally funded or led projects;
• providing for visiting academics as detached national experts.

A list of the current research projects that Agency is participating in is available under research projects.

European Platform for Regulatory Science Research

EMA and the Heads of Medicines Agency intend to launch the European Platform for Regulatory Science Research in 2025.

This platform aims to foster collaboration among academic regulatory science researchers and regulators in Europe and beyond.

Its main objectives are to:

• advance and accelerate regulatory science research;
• increase the quality and impact of research and its outcomes;
• improve regulatory practices, standards, development and use of medicinal products.

Draft concept paper on the European Platform for Regulatory Science Research

Draft: consultation closedConsultation dates: 14/11/2024 to 18/12/2024Reference Number: EMA/530334/2024Summary:

Regulators and developers need high-quality tools to keep pace with scientific and technological advances and particularly to ensure the robust assessment of therapies and outcomes fitting patients’ needs. Research into regulatory science aims to address issues in development and evaluation as well as gaps that hinder regulatory advancement. EMA/HMA are launching the new European Platform for Regulatory Science Research. The platform aims to advance and accelerate regulatory science research, to increase the quality and impact of research and outcomes, thereby improving regulatory practices, standards, development and use of medicines and relevant devices or other technologies. Fostering the exchange and collaboration between researchers from the academic sector and regulators will help the system address gaps and research needs in regulatory science, improve the usefulness of outputs, and support the translation of solutions into the practice of regulators and developers. Please provide comments using this template. The completed comments form should be sent to [e-mail].

Working with the Agency

The Agency may be able to take part in certain research projects in collaboration with external parties, if the projects support the Agency's health mission. The Agency can take part on a number of levels:

• as coordinator of a research project;
• as a participant in research activities;
• with an advisory role.

The Agency bases its decisions on which projects it can take part in on these criteria:

• the applicability and relevance to the Agency's work;
• the added value of contribution from regulators to the project;
• the need for continuing and strengthening collaboration with other institutional and international bodies;
• the quality and soundness of the research proposal;
• confidentiality and access to data;
• conflicts of interest.

The Agency welcomes the sharing of results and data with potential public-health impact by researchers, even before these have been published in a peer-reviewed journal.

Full details of the types of activities that the Agency is involved in, the degree of involvement, funding arrangements and the process for enquiring about embarking upon a research project with the Agency are available in this document:

European Medicines Agency process for engaging in externally funded regulatory sciences and process improvement research activities for public and animal health

Reference Number: EMA/158095/2019Summary:

This document sets out an agency-wide approach to the agency’s engagement in research activities notably in regulatory sciences to support regulatory decision-making and to improve business processes for the benefit of public and animal health.