The European Medicines Agency (EMA) is committed to maintaining a strong working relationship with European academics and researchers. Collaboration between the Agency and academia is necessary for the Agency to be prepared for future challenges and opportunities offered by advances in science and technology. The Agency has targeted engagement with academia, learned societies and research groups in a range of areas.
EMA provides regulatory and scientific support to foster development of new and innovative medicines, from the early phases in the laboratory all the way to the patient.
EMA achieves it through the following resources:
- Innovation Task Force
- EU Innovation Network
- SME Office
- PRIME scheme
- Qualification advice on novel methodologies
- Scientific advice / protocol assistance
EMA can provide protocol assistance free of charge to academic organisations developing orphan medicines, as of 19 June 2020. EMA offers this incentive to further encourage the development of medicines for rare diseases.
For more information, see Fees payable to the European Medicines Agency.
For more information on how the Agency supports medicine developers, see EMA tools available to medicine’s developers from the academic sector.
Regulatory Science to 2025
EMA's Regulatory Science Strategy Plan to 2025 aims to develop strong engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.
EMA seeks the expert input of healthcare professionals (i.e. academics, researchers, clinicians) and patients in its work through several channels, including:
- as members and experts of its scientific committees, working parties and scientific advisory groups;
- in the preparation of scientific guidelines;
- as seconded national experts;
- as visiting experts;
- as participants in the Agency's conferences, workshops and public consultations;
- as prescribers and handlers of the medicines that the Agency evaluates.
If the Agency needs expert input to help with a particular activity or piece of work, other collaboration opportunities may arise. Such collaborations are non-remunerated and exclude any direct involvement in the authorisation and supervision of human or veterinary medicines.
How to get involved as an expert
All experts need to complete certain forms before their involvement in specific EMA activities, in particular those related to the assessment of medicines. These include:
- the declaration-of-interests and confidentiality-agreement form: EMA has a robust conflicts of interests policy to ensure that experts participating in the Agency's activities have no interests in the pharmaceutical industry that could affect their impartiality. As part of this policy, all patient and consumer representatives working with the Agency must complete a public declaration of interests and confidentiality form;
- the expert-nomination form and e-curriculum vitae (e-CV): all experts need to complete a nomination form and electronic curriculum vitae.
For more guidance on filling in the forms, please see the Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae.
Programme for young researchers
EMA encourages young researchers/professionals interested in EMA's work to explore the ten-month traineeship programme. This is an opportunity for recent graduates to learn new skills and get a valuable work experience.
How to learn more about EMA activities
EMA provides several training resources in the format of videos, presentation slides and related documents, for those interested in learning more about the Agency activities.
EMA is involved in a number of research projects with academia, learned societies and research groups, as part of its mission to foster scientific excellence in the evaluation and supervision of medicines. EMA believes that performing research following the regulatory standards brings public health benefits.
The research projects are mostly funded by Horizon 2020, the largest ever European Union (EU) funding programme for research and innovation. The Agency provides support to medicine developers and researchers applying for funding and engages in externally funded projects either as consortium member or as part of an advisory board.
The Agency also supports other H2020 initiatives, including Marie Skłodowska-Curie actions (MSCA), giving the opportunity to host visiting students in the framework of the related project.
EMA is involved in other research projects, that are part of the Innovative Medicines Initiative.
For more details on EMA involvement in externally funded projects, including funding arrangements and the process for enquiring about the Agency involvement, see European Medicines Agency process for engaging in externally funded regulatory sciences and process improvement research activities for public and animal health.
For more information on EMA's approach to contributing to research:
The EMA Management Board adopted a framework for collaboration between EMA and academia in March 2017. This aims to:
- raise awareness of EMA's role within the European medicines regulatory network;
- promote and further develop regulatory support for translating academic research into novel methodologies and medicines;
- ensure that the best scientific expertise and academic research is available to inform regulatory decision-making;
- collaborate on areas of research on regulatory science, such as novel approaches, endpoints and methodologies.
EMA published the framework and the action plan in April 2017:
- Framework for collaboration between EMA and academia
- Annex I - Framework for collaboration between EMA and academia: action plan
This framework is in line with EMA's overarching framework for stakeholder relations management, which the EMA Management Board adopted in June 2016.