Programme Category
Programme Name
Programme Description
Horizon Europe is the European Union (EU) funding programme for the period 2021 – 2027, which targets the sectors of research and innovation. The programme’s budget is around € 95.5 billion, of which € 5.4 billion is from NextGenerationEU to stimulate recovery and strengthen the EU’s resilience in the future, and € 4.5 billion is additional aid.
Identifier Code
Call
Summary
The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products). Such combined ATMPs are composed of an ATMP and one or more medical devices or one or more active implantable medical devices, and their cellular or tissue part must either contain viable cells or tissues, or non-viable cells or tissues liable for exerting the primary action on the human body.
Research should focus on advanced stages of clinical development with regulatory work on the Medical Device part completed and safety studies of the combination product in an advanced stage.
Detailed Call Description
Proposals should address all of the following activities:
- Phase 2 clinical trials and above of combined ATMPs focussing on:
- technologies ready to undergo interventional clinical trials in patients/end users assessing the usability and clinical performance, and/or
- technologies that have demonstrable safety/performance profiles and should undergo clinical validation in view of their inclusion into guidelines for specific clinical pathways.
- Delivery of safe and clinically validated combined ATMPs that are compliant with current European regulatory requirements. The related regulatory work should be considered as an essential component and the proposed work should involve consultation/interaction with competent regulatory agencies such as the European Medicines Agency (EMA) or national regulatory agency. Applicants are encouraged to seek regulatory and/or Health Technology Assessment (HTA) advice as appropriate.
The combined ATMPs should be more effective than current state-of-the-art solutions on the European market owing to improved features like personalisation, accuracy, reliability and usability and contribute to long-term sustainability (faster and affordable) of European health systems.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
100%
Contribution per project: between €8,00 and €10,00 million
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Associations
- Large Enterprises
- Legal Entities
- Natual person / Citizen / Individual
- Private Bodies
- Researchers/Research Centers/Institutions
- Semi-governmental organisations
- Small and Medium Enterprises (SMEs)
Eligibility For Participation Notes
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.
- Healthcare providers
- Developers and manufacturers, EU companies
- Patients
Call Opening Date
Call Closing Date
National Contact Point(s)
Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia
P.O.Box 23422, 1683 Nicosia
Telephone: +357 22205000
Email Address: support@research.org.cy
Website: https://www.research.org.cy/en/
Contact Persons:
George Christou
Scientific Officer
Email: gchristou@research.org.cy
Ioannis Theodorou
Scientific Officer
Telephone: +357 22 205 038
Contact Email: itheodorou@research.org.cy
(Publish Date: 08/02/2023-for internal use only)
EU Contact Point
European Commission, Directorate-General for Research and Innovation
https://ec.europa.eu/info/departments/research-and-innovation_en#contact