Horizon 2020 research funding
The European Medicines Agency (EMA) provides support to medicine developers that may be helpful for researchers applying for funding under the European Commission's Horizon 2020 programme in the area of health.
Horizon 2020 is the largest ever European Union (EU) funding programme for research and innovation. It has a budget of nearly €80 billion and will run until 2020.
Academic researchers in the field of medicine development may be eligible for funding under the 'Health, demographic change and wellbeing' thematic area of the Horion 2020 work programme running from 2018-20.
One of the aims of the work programme is to enable the development of new, safer and more effective human medicines and interventions.
EMA encourages researchers to check the information on eligibility and the application process on the Commission's website.
In addition, as applicants may be expected to address regulatory aspects in their research proposals, the Agency advises them to familiarise themselves with relevant regulatory procedures and support available from EMA and at national level.
EMA advises applicants to:
- ensure that their proposals incorporate scientific advice and follow relevant scientific guidelines;
- contact EMA or regulators at national level when appropriate;
- check relevant submission timelines and deadlines;
- familiarise themselves with fees and fee exemptions for relevant procedures;
- incorporate regulatory input throughout their project and at all stages of the medicine development process.
EMA's regulatory information and support is relevant at all stages of medicine development.
Horizon 2020 research porposals should be presented at a mature stage, meaning that they are ready to be implemented. Once funding is offered to successful applicants, they can only make minor changes to their proposals during the grant agreement preparation and project implementation phases. For more information, see European Commission: H2020 grant preparation manual.
The regulatory procedure for the qualification of novel methodologies for medicine development is particularly relevant for Horizon 2020 proposals.
Proposals focusing on the development of novel methodologies should address relevant regulatory requirements and the acceptability of these methodologies for use in medicine development.
EMA's qualification of novel methodologies provides a voluntary scientific pathway to establish this acceptability. This includes, for example, the validation of biomarkers, clinical outcome assessments, statistical or imaging methods, new animal models, innovative clinical trial methodologies and 'big data' approaches.
EMA has published guidance to applicants for the qualification of novel methodologies, including information on procedural timeframe, fees and a dedicated contact point:
To provide further help to applicants, EMA has also published a guidance document highlighting the major challenges and limitations that can compromise a successful qualification process:
EMA engages in early regulatory dialogue with medicines developers via the Innovation Task Force (ITF), a multidisciplinary group that includes scientific, regulatory and legal expertise. The ITF focuses on innovative aspects in medicines development.
Horizon 2020 applicants and grantees can request scientific advice at any stage of development of a medicine or a novel methodology. Incorporating scientific advice from EMA or national regulators can substantially strengthen the scientific quality and the potential impact of their research proposals.
Scientific advice procedures provide regulatory guidance on the appropriate tests and studies during the development of a medicine. This provides medicines developers an opportunity to discuss the appropriateness of proposed approaches that are not satisfactorily addressed by available guidelines.
EMA's Committee for Medicinal Products for Human Use (CHMP) provides scientific advice and protocol assistance for human medicines, on the recommendation of the Scientific Advice Working Party (SAWP). National regulators also provide scientific advice.
For more information and submission deadlines, see: