Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators
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 proposals should focus on alternatives to the use of animals for regulatory safety and efficacy testing. Applicants should propose activities that bring together NAM developers and NAM users with European regulators responsible for the safe use of chemicals (e.g. industrial chemicals, pesticides, biocides and cosmetics) and pharmaceuticals in order to inform on NAM solutions available and to encourage the building of a framework on how these NAMs could be most effectively used in the different decision-making contexts. For NAMs applicable to chemical risk assessment, collaboration with existing initiatives such as the Partnership for the Assessment of Risks from Chemicals (PARC) and the ASPIS cluster of projects (Animal-free Safety Assessment of chemicals: Project cluster for Implementation of novel Strategies) is encouraged.
Detailed Call Description
To build such a framework the proposals should address all of the following:
- develop technical and regulatory readiness criteria
- reflect on how to provide mechanisms to support technology transfer, i.e. bringing promising NAMs to the market (including optimisation and transferability assessment)
- discuss how to standardise NAMs and NAM-based strategies via OECD, CEN, ISO, ICH, VICH and other international organisations, as applicable
- provide technical training for Contract Research Organisations (CROs) applying NAMs for regulatory purposes
- promote dialogue (involving companies, regulatory bodies on EU level, including ECHA, EMA and EFSA and Member States authorities) on how to integrate and interpret data from NAMs and facilitate their uptake for safety and efficacy testing of chemicals (including pesticides) and pharmaceuticals, while addressing the lack of reliability and shortcomings of the current tools based on animal procedures
- identify obstacles in EU legislation for the regulatory use of NAMs and propose options/changes in the EU regulatory framework which address these obstacles and facilitate the uptake and use of NAMs
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
100%
EU contribution per project: €2.00 million
Thematic Categories
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- International Organisations
- Large Enterprises
- Legal Entities
- Private Bodies
- Researchers/Research Centers/Institutions
- State-owned Enterprises
Eligibility For Participation Notes
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, legal entities established in the United States of America may exceptionally participate as a beneficiary or affiliated entity, and are eligible to receive Union funding.
Coordinators of projects must be legal entities established in an EU Member State or Associated Country.
The Joint Research Centre (JRC) may participate as member of the consortium selected for funding.
Call Opening Date
Call Closing Date
National Contact Point(s)
Research and Innovation Foundation
29a Andrea Michalakopoulou, 1075 Nicosia,
P.B. 23422, 1683 Nicosia
Telephone: +357 22205000
Fax: +357 22205001
Email: 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
Email: itheodorou@research.org.cy
EU Contact Point
European Commission, Directorate-General for Research and Innovation
https://ec.europa.eu/info/departments/research-and-innovation_en#contact