Horizon 2020 research funding

The European Medicines Agency (EMA) provided support to medicine developers that may have been helpful for researchers applying for funding under the European Commission's Horizon 2020 programme in the area of health.

Horizon 2020 was the largest ever European Union (EU) funding programme for research and innovation. It had a budget of nearly €80 billion and ran until 2020.

Academic researchers in the field of medicine development may have been 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 was to enable the development of new, safer and more effective human medicines and interventions.

General advice

EMA encouraged researchers to check the information on eligibility and the application process on the Commission's website.

In addition, as applicants could have been expected to address regulatory aspects in their research proposals, the Agency advised them to familiarise themselves with relevant regulatory procedures and support available from EMA and at national level.

EMA advised applicants to:

EMA's regulatory information and support is relevant at all stages of medicine development.

Horizon 2020 research proposals had to be presented at a mature stage, meaning that they were ready to be implemented. Once funding was offered to successful applicants, they could 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.

Novel methodologies

The regulatory procedure for the qualification of novel methodologies for medicine development was particularly relevant for Horizon 2020 proposals.

Proposals focusing on the development of novel methodologies needed to address relevant regulatory requirements and the acceptability of these methodologies for use in medicine development.

EMA's qualification of novel methodologies provided a voluntary scientific pathway to establish this acceptability. This included, 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 had 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 had also published a guidance document highlighting the major challenges and limitations that could 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.

Scientific advice

Horizon 2020 applicants and grantees could request scientific advice at any stage of development of a medicine or a novel methodology. Incorporating scientific advice from EMA or national regulators could 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.

Protocol assistance is scientific advice for developers of medicines for rare diseases with an orphan designation.

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:

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