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Call key data
Clinical trials of combined Advanced Therapy Medicinal Products (ATMPs)
|Funding Program||Horizon Europe - Cluster 1 - Destination 5: Unlocking the full potential of new tools, technologies and digital solutions for a healthy society|
|Call budget||€ 50,000,000.00|
|Estimated EU contribution per project||between € 8,000,000.00 and € 10,000,000.00|
|Link to the call||ec.europa.eu|
|Link to the submission||ec.europa.eu|
The subjects of this topic are combined ATMPs (Advanced Therapy Medicinal Products) according to the definition of the ATMP-regulation (EU 1394/2007, Article 2d). 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.
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.
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.
Proposals should address all of the following activities:
The topic invites proposals that include innovative treatments for any medical condition excluding rare diseases that are ready to be assessed for clinical efficacy (performance and clinical benefit) in a specific indication on a big number of patient cohorts; already existing market solutions are not in the scope of this topic.
Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors and any other non-health related individual attributes should be taken into consideration. SME participation is strongly encouraged.
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.
|Expected effects and impacts|
|Regions / countries for funding||EU Member States, Overseas Countries and Territories (OCT)|
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Island (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), Morocco (المغرب), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
|eligible entities||EU Body, Education and training institution, International organization, Natural Person, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)|
To be eligible for funding, applicants must be established in one of the following countries:
Applications may be submitted by one or more legal entities, which may be established in a Member State, Associated Country or, in exceptional cases and if provided for in the specific call conditions, in another third country.
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.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
Digitalisation, Digital Society, ICT,
Health, Social Services, Sports
|Relevance for EU Macro-Region||EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region|
|UN Sustainable Development Goals (UN-SDGs)|
All proposals must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Proposals must be complete and contain all parts and mandatory annexes and supporting documents, e.g. plan for the exploitation and dissemination of the results including communication activities, etc.
The application form will have two parts:
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 45 pages.
The award criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
The rules for the legal and financial set-up of the grant agreements are described in General Annex G. The following exceptions apply: In order to optimise synergies and increase the impact of the projects, all projects selected for funding from this topic will form a cluster and be required to participate in common networking and joint activities (and in determining modalities for their implementation and the specific responsibilities of projects). Depending on the scope of proposals selected for funding, these activities may include:
|Call documents|| HE-Work Programme 2023-2024, Cluster 1, Destination 5 (481kB)
|Contact||National Contact Points for Horizon Europe |
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