Programme Category
Programme Name
Programme Description
The European Defence Fund (EDF) is the Commission’s initiative to support collaborative defence research and development, and to foster an innovative and competitive defence industrial base.
Identifier Code
Call
Summary
This topic has opened under the call ”Defence medical countermeasures” (EDF-2021-MCBRN-D).
Proposals should focus on innovation and development of medical countermeasures (MCMs) against Chemical, Biological, Radiological and Nuclear (CBRN) threats as well as their integration into armed forces. Proposals may also provide for analysis of the relevance and feasibility of novel MCMs and related technology, mapping of CBRN MCM capacities across EU, as well as options for ensuring EU’s access and availability of MCMs. MCMs may include any medicines or medical devices that are aimed at combating CBRN threats. This extends both to countermeasures that prevent or treat the threat.
Detailed Call Description
The proposals must cover the following activities, not excluding possible upstream and downstream activities eligible for development actions if deemed useful to reach the objectives:
- Studies, such as feasibility studies to explore the feasibility of new or improved technologies, products, processes, services and solutions.
- The design of a defence product, tangible or intangible component or technology as well as the definition of the technical specifications on which such design has been developed which may include partial tests for risk reduction in an industrial or representative environment.
Integrating knowledge, testing, qualification, and certification of MCMs, as defined below, are desirable. Given that they concern CBRN MCMs, these activities are specific and should be understood, e.g. for immunotherapies, as:
- Integrating knowledge:
- choice of pharmacological target, antigen, or physiological process; target or antibody validation; elucidation of mechanism of action.
- development of industrial production under GMP conditions; demonstration of the stability of MCMs (GMP) in bulk and distributed form (ICH Stability testing of new drug substances and drug products).
- Studies: In vitro assays, in aerosol particles, in vivo proof of concept studies, and mapping of defence industrial CBRN MCM capacities.
- Design: Preclinical trials (DRS, safety, efficacy) on relevant animal models, quality control tests, validation of industrial production process under GMP conditions. Pivotal efficacy studies on animal models as close as possible to humans (authorisation under exceptional circumstances).
- Testing: phase I clinical trial with most advanced MCM candidates.
- Qualification: finalisation of a dossier for marketing authorisation.
- Certification: New drug application (NDA) delivered by the regulatory authority (EMA) or early access programme.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
100%
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Central Government
- International Organisations
- Large Enterprises
- Private Bodies
- Researchers/Research Centers/Institutions
- Small and Medium Enterprises (SMEs)
- State-owned Enterprises
Eligibility For Participation Notes
The action shall be carried out by legal entities cooperating within a consortium of at least three eligible legal entities which are established in at least three different Member States or associated countries. At least three of those eligible legal entities established in at least two different Member States or associated countries shall not, during the entire period in which the action is carried out, be controlled, directly or indirectly, by the same legal entity and shall not control each other.
The admissibility and eligibility conditions are described under Article 9 and Article 10(4) of the EDF regulation.
Call Opening Date
Call Closing Date
National Contact Point(s)
Ministry of Defense
172-174 Strovolos Avenue, 2048 Strovolos, Nicosia,
website: https://mod.gov.cy/
Telephone: 22 807500
Email: defence@mod.gov.cy
Department of Research and Innovation
Phones: 22 807755, 22 807754
Email: research.innovation@mod.gov.cy
(Publish Date: 29/09/2021-for internal use only)
EU Contact Point
European Directorate-General for Defence Industry and Space (DEFIS)
https://ec.europa.eu/info/departments/defence-industry-and-space_en