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Call key data
Boosting the translation of biotech research into innovative health therapies
Funding Program
Horizon Europe: Cluster 1 - Health
Call number
HORIZON-HLTH-2025-01-TOOL-05
deadlines
Opening
22.05.2025
Deadline
16.09.2025 17:00
Funding rate
100%
Call budget
€ 80,000,000.00
Estimated EU contribution per project
between € 4,000,000.00 and € 8,000,000.00
Link to the call
Link to the submission
Call content
short description
This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Developing and using new tools, technologies and digital solutions for a healthy society”.
Call objectives
The Commission Communication 'Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU' has recently identified research and technology transfer to the market as a major challenge for the biotechnology sector. This topic aims to speed up the development of innovative biotechnology-based therapies by supporting the initial phases of clinical research. SMEs play a key role in the EU's potential to innovate, with most biotechnology-derived drugs in development being progressed by SMEs and small biotech companies. However, transitioning from drug discovery and development stages to approved products requires substantial investment and sufficient resources in different areas (e.g., manufacturing, clinical trial management, regulatory affairs, etc.), with the time needed for clinical development often exceeding 10 years. This topic targets collaborative multidisciplinary consortia of SMEs, academics, clinicians and research organisations bringing together the necessary expertise to launch the clinical development of novel biotechnology-derived therapeutics. Collaboration with the relevant European research infrastructures is encouraged. This topic does not address the full clinical development needed to bring products to market but aims to support the critical transition phase from preclinical to clinical development by supporting the early clinical phases. A non-exhaustive list of biotechnology-derived therapies in scope include monoclonal antibodies, (therapeutic) vaccines, recombinant biomolecules, Advanced Therapy Medicinal Products (ATMPs), nano-based drugs, RNA therapies etc. Whole blood, blood components and other substances of human origin are not within the scope of this topic.
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Expected effects and impacts
Proposals submitted under this topic should include all the following elements:
- A Clinical study either phase I, II or I/II depending on the appropriate stage of development.
- The proposal should convincingly demonstrate a significant economic potential of the final product(s) for the Single Market.
- A clearly defined exploitation plan, with a detailed proposed route to commercialisation, description of the intellectual property ownership and benefit for the SME(s). The plan should include an anti-shelving strategy, commercial forecasts for the product sales & revenue, and strategies for follow-up financing as well as market authorisation. The exploitation strategy should envisage a first deployment in the EU.
- Justification of the patient populations that will benefit directly from the development of the therapies. Clinical indications where potentially large patient populations could benefit will be favoured.
Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.
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Expected results
Proposals under this topic should aim to deliver results directed towards and contributing to all the following expected outcomes:
- Healthcare providers, researchers and patients get faster access to innovative therapies.
- The European Union benefits from more clinical trials being conducted with new biotech therapeutic approaches.
- The competitiveness of small and medium-sized enterprises (SMEs) from the EU and Associated Countries within the health biotech sector is strengthened.
Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Canada, Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), New Zealand (Aotearoa), 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, 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)
Mandatory partnership
Yes
Project Partnership
To be eligible for funding, applicants must be established in one of the following countries:
- the Member States of the European Union, including their outermost regions
- the Overseas Countries and Territories (OCTs) linked to the Member States
- countries associated to Horizon Europe - see list of particpating countries
Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:
- at least one independent legal entity established in a Member State; and
- at least two other independent legal entities, each established in different Member States or Associated Countries.
In addition to the eligibility conditions as described in General Annex B, the consortium must be composed of at most 5 legal entities as beneficiaries.
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.
other eligibility criteria
Specific cases:
- Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
- Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
- Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
- Legal entities created under EU law (EU bodies) including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
- International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
- Joint Research Centre (JRC)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
- Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
- EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
- Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia but whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity. - Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.).In case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.
Additional information
Topics
Relevance for EU Macro-Region
EUSDR - EU Strategy for the Danube Region, EUSBSR - EU Strategy for the Baltic Sea Region, EUSALP - EU Strategy for the Alpine Space, EUSAIR - EU Strategy for the Adriatic and Ionian Region
UN Sustainable Development Goals (UN-SDGs)
project duration
max. 4 years
Additional Information
Applications 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.
Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.
Applications must be complete and contain all parts and mandatory annexes and supporting documents.
The application form will have two parts:
- Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
- Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.
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.
In order to prove that the investigational product is ready for clinical testing, proposals must provide evidence of regulatory approval in the EU already in place for phase I clinical study.
The proposed EU contribution going to small and medium-sized enterprises (SMEs) must be 50% or more of the total EU contribution to the project as a whole.
Call documents
Horizon Europe Work Programme 2025 Cluster 1 - HealthHorizon Europe Work Programme 2025 Cluster 1 - Health(1200kB)
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