Gaining experience and confidence in New Approach Methodologies (NAM) for regulatory safety and efficacy testing – coordinated training and experience exchange for regulators
HORIZON Coordination and Support Actions
Basic Information
- Identifier
- HORIZON-HLTH-2024-IND-06-09
- Programme
- A competitive health-related industry (Single stage - 2024)
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- October 26, 2023
- Deadline
- April 11, 2024
- Deadline Model
- single-stage
- Budget
- €2,000,000
- Min Grant Amount
- €2,000,000
- Max Grant Amount
- €2,000,000
- Expected Number of Grants
- 1
- Keywords
- HORIZON-HLTH-2024-IND-06-09HORIZON-HLTH-2024-IND-06Medical biotechnologyPharmacodynamicsPharmacokineticsPharmacology, pharmacogenomics, drug discovery and design, drug therapyToxicologyTranslational medicine
Description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 6 “Maintaining an innovative, sustainable and globally competitive health industry”. To that end, proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to all of the following expected outcomes:
- European regulators gain state-of-the-art knowledge on different NAMs that are being proposed for the assessment of the safety and efficacy of chemicals and pharmaceuticals;
- European regulators understand better the shortcomings of the current tools based on animal procedures for the assessment of chemicals and pharmaceuticals;
- European regulators collaborate on a framework on how to assess the safety of chemicals based on NAM-data and how to classify the hazardous properties based on such data;
- European regulators collaborate on a similar framework for assessment of safety and efficacy of pharmaceuticals based on NAM-data;
- Citizens benefit from the supply and use of chemicals and pharmaceuticals that have been assessed through NAMs that are better predicting potential effects in humans than the current assessment methods;
- Industry has an improved competitive position with the availability of harmonised and standardised NAM-based assessment tools that are faster and more flexible;
- European Commission and Member States regulators are responding to the societal demand to move away from animal testing.
There is increasing scientific evidence pointing to the limitations of animal testing for safety and efficacy assessment of chemicals and pharmaceuticals. Europe is also experiencing a strong societal demand to move away from animal testing. Scientific progress of the past two decades has produced a number of animal-free New Approach Methodologies (NAMs) that have the potential to be used instead of the animal models that are currently employed for such testing. However, knowledge, experience and confidence on how results from the NAM assays could be used is still lacking among regulators, which could limit the industry’s use of NAMs because of lack of legal certainty when generating safety and health data requested by EU legislation.
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.
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
Proposals should consider involving the JRC to take advantage of its expertise and relevant activities in bridging research and regulatory communities and facilitating uptake of NAMs for regulatory application. In that respect, the JRC is open to collaborate with any successful proposal after its approval.
Destination & Scope
Calls for proposals under this destination are directed towards the Key Strategic Orientation KSO-A ‘Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains’ of Horizon Europe’s Strategic Plan 2021-2024. Research and innovation supported under this destination should contribute to the impact area ‘A competitive and secure data-economy’ and in particular to the following expected impact, set out in the Strategic Plan for the health cluster: ‘EU health industry is innovative, sustainable and globally competitive thanks to improved up-take of breakthrough technologies and innovations, which makes the EU with its Member States more resilient and less dependent from imports with regard to the access to and supply of critical health technologies’. In addition, research and innovation supported under this destination could also contribute to the following impact areas: ‘Industrial leadership in key and emerging technologies that work for people’, ‘High quality digital services for all’, and ‘Good health and high-quality accessible health care’.
The health industry is a key driver for growth and has the capacity to provide health technologies to the benefit of patients and providers of health care services. The relevant value chains involve a broad variety of key players from supply, demand and regulatory sides. In addition, the path of innovation in health is long and complex. The development of novel health technologies is generally associated with uncertainties and market barriers due to expensive and risky development (e.g. high attrition rate in pharmaceutical development), high quality and security requirements (e.g. clinical performance, safety, data privacy and cybersecurity) and market specificities (e.g. strong regulation, pricing and reimbursement issues). In addition, the growing concern about environmental issues is putting more pressure on this industry. Therefore, there is a need for research and innovation integrating various stakeholders to facilitate market access of innovative health technologies (medical technologies, pharmaceuticals, biotechnologies, digital health technologies).
In order to address these challenges, in particular green and digital transitions and proper supply of health technologies and products, destination 6 will focus on research and innovation activities that aim at:
- Facilitating the production of pharmaceuticals in compliance with the objectives of the European Green Deal.
- Developing methodologies, guidelines and standards, assessment studies, and structuring activities adapted to digital solutions and interventions for GDPR compliant translation into health care practice, including inter-operability, cyber-security and data confidentiality.
- Supporting public authorities with better methodologies and interdisciplinary approaches to assess and value new health technologies and interventions.
In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other clusters (under pillar II of Horizon Europe). For instance, with cluster 4 “Digital, Industry and Space” such as on industrial research and innovation infrastructures (pilot plants, testing and simulation facilities, open innovation hubs); additive manufacturing and other production technologies (incl. bio manufacturing); safe, smart and sustainable materials.
Expected Impacts:
Proposals for topics under this destination should set out a credible pathway to contributing to maintaining an innovative, sustainable and globally competitive health industry, and more specifically to one or several of the following expected impacts:
- Health industry in the EU is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and digital technologies, contributing to job creation and economic growth, in particular with small- and medium-sized enterprises (SMEs).
- Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, health care providers, health authorities and regulators ensuring suitability and acceptance of solutions.
- European standards, including for operations involving health data, ensure patient safety and quality of healthcare services as well as effectiveness and interoperability of health innovation and productivity of innovators.
- Citizens, health care providers and health systems benefit from a swift uptake of innovative health technologies and services offering significant improvements in health outcomes, while health industry in the EU benefits from decreased time-to-market.
- Health security in the EU benefits from reliable access to key manufacturing capacity, including timely provision of essential medical supplies of particularly complex or critical supply and distribution chains, such as regards vaccines or medical radioisotopes.
Eligibility & Conditions
General conditions
2. Eligible countries: described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
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.
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes.
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes.
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes.
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme.
Documents
Call documents:
Standard application form (HE CSA) - call-specific application form is available in the Submission System
Standard evaluation form (HE CSA)
HE General MGA v1.0
Information on clinical studies (HE)
Additional documents:
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Programme Guide
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Funding & Tenders Portal Terms and Conditions
Funding & Tenders Portal Privacy Statement
Support & Resources
Online Manual is your guide on the procedures from proposal submission to managing your grant.
Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular.
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CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal.
The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers.
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Latest Updates
CALL UPDATE: FLASH EVALUATION RESULTS
EVALUATION results
Published: 07.12.2022
Deadline: 11.04.2024
Available budget: EUR 2,000,000
We recently informed the applicants about the evaluation results for their proposals.
The results of the evaluation for the topic HORIZON-HLTH-2024-IND-06-09 are as follows:
Number of proposals submitted (including proposals transferred from or to other calls): 4
Number of inadmissible proposals: 0
Number of ineligible proposals: 0
Number of above-threshold proposals: 1
Total budget requested for above-threshold proposals: EUR 1,977,390
Number of proposals retained for funding: 1
Number of proposals in the reserve list: 0
Funding threshold: 14.5
Ranking
Number of proposals with scores lower or equal to 15 and higher or equal to 14: 1
Number of proposals with scores lower than 14 and higher or equal to 13: 0
Number of proposals with scores lower than 13 and higher or equal to 12: 0
Summary of observers’ report:
Two independent observers were asked to assist the European Health and Digital Executive Agency (HaDEA) in the evaluation of proposals submitted to 9 single and two-stage calls (covering 14 topics) with deadline on 11 April 2024, which were discussed during 2.5 weeks of consensus meetings. They followed the evaluation in order to assess and report on the implementation of the evaluation procedures, on the conduct and fairness of the evaluation process and on the application of the evaluation criteria. Based on the analysis conducted, the observers give independent advice for improvement of the evaluation process.
The evaluation process was fully transparent. The rules and guidelines to be followed were clearly communicated by documents provided to experts, by online and on-site briefings and by instructions given and, where necessary, repeated by the moderators. This ensured a fair and transparent procedure. The evaluation was conducted in an extremely fair and professional way, thanks to a thorough and meticulous preparation and to the helpful and competent HaDEA staff involved, including the quality checkers and the assistant team.
The independent observers were impressed by the high quality of the evaluation, and made some further recommendations, for consideration in setting up the rules for the next framework programme. The most important advice is that a higher weight should be assigned to the Excellence criterion. It has at present a weight of 1/3 of the final score. This should be increased, as scientific excellence is the most important factor that determines the quality of a project. Such a change would be in line with international practices.
For questions, please contact the Research Enquiry Service.
Call HORIZON-HLTH-2024-IND-06 has closed on 11 April 2024.
10 proposals have been submitted. The breakdown per topic is:
- HORIZON-HLTH-2024-IND-06-08: 6 proposals
- HORIZON-HLTH-2024-IND-06-09: 4 proposals
Evaluation results are expected to be communicated in July 2024 at the earliest.