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Grant Analysis

Purpose & Target

The core objective of this grant is to speed up the development of innovative biotechnology-based therapies by supporting their initial clinical research phases. It explicitly targets consortia comprising small and medium-sized enterprises (SMEs), academics, clinicians, and research organizations. - This is a SECTOR-SPECIFIC grant focused on health-related biotechnology. - The geographic scope includes all EU Member States and Associated Countries. - Key filtering criteria for initial screening include a focus on early clinical phases (I, II, or I/II) of biotechnology-derived therapies, prior regulatory approval in the EU for phase I clinical study, and a requirement to demonstrate significant economic potential for the European Single Market. - This grant is part of the recurring Horizon Europe program context.

Financial Structure

The total budget for this topic (HORIZON-HLTH-2025-01-TOOL-05) is 80,000,000.0 EUR.
There are an expected 10 grants to be awarded under this topic.
The minimum EU contribution per project is 4,000,000.0 EUR.
The maximum EU contribution per project is 8,000,000.0 EUR.
The currency for all financial amounts is EUR.
A specific co-financing-like requirement mandates that the 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. This is a distribution requirement, not a matching fund.
Eligible costs are those typically associated with Research and Innovation Actions (RIA) within Horizon Europe, covering activities from pre-clinical to early clinical development.
Whole blood, blood components, and other substances of human origin are explicitly ineligible for funding under this topic's scope.

Eligibility Requirements

Organizational Type and Structure

Eligible applicants must be part of a consortium.
The consortium must be composed of at most 5 legal entities as beneficiaries.
Eligible organization types include: SMEs, academics, clinicians, and research organizations. Larger enterprises are also eligible as part of the consortium.

Financial Requirements

The EU contribution going to small and medium-sized enterprises (SMEs) within the consortium must be 50% or more of the total EU contribution to the project as a whole.

Geographic and Regulatory Requirements

Legal entities must be established in EU Member States or countries associated with the Horizon Europe programme (specific list of Associated Countries detailed in Annex B of the Work Programme General Annexes).
The investigational product proposed for the clinical study must have regulatory approval in the EU already in place for phase I clinical study.

Technical and Scope Requirements

Proposals must include a clinical study, specifically Phase I, II, or I/II, depending on the appropriate stage of development.
If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

Exclusion Criteria

Whole blood, blood components, and other substances of human origin are explicitly not within the scope of this topic.
Entities assessed as “high-risk suppliers” of mobile network communication equipment (and any entities they own or control) are not eligible to participate if the topic is identified as “subject to restrictions for the protection of European communication networks.” (Note: This specific topic does not explicitly state it is subject to these restrictions in the provided text, but it is a general condition mentioned in the broader work programme context.)

Application Process

Application Timeline

The submission session for this topic is now available (planned opening date was 2025-05-22).
The application deadline is 2025-09-16 00:00:00+00.
The project duration should not exceed 4 years.

Application Procedure

Applications follow a single-stage submission procedure.
Proposals must be submitted via the Electronic Submission System.

Required Documentation and Materials

Applicants must use the Standard application form (HE RIA, IA) available in the Submission System.
A dedicated annex for clinical studies must be provided, using the template available in the submission system. This is strongly encouraged given the clinical study component.

Implementation and Reporting Obligations

Legal and financial set-up of the grants, including reporting and monitoring requirements, are described in Annex G of the Work Programme General Annexes.
Proposals should include a clearly defined exploitation plan with a detailed proposed route to commercialization, including strategies for follow-up financing and market authorization.

Application Assistance and Support

Online Manual: Comprehensive guide on procedures from proposal submission to grant management.
Horizon Europe Programme Guide: Detailed guidance on the structure, budget, and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ: Answers to frequently asked questions on submission, evaluation, and grant management.
Research Enquiry Service: For general questions about European research and EU Research Framework Programmes.
National Contact Points (NCPs): Provide guidance, practical information, and assistance on participation in Horizon Europe within specific countries.
Enterprise Europe Network: Offers advice to businesses, especially SMEs, including guidance on EU research funding.
IT Helpdesk: For technical issues related to the Funding & Tenders Portal (e.g., login, submission).
European IPR Helpdesk: Assists with intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: Advise on standardisation in project proposals.
European Charter for Researchers and the Code of Conduct for their recruitment: Provides principles and requirements for researchers, employers, and funders.

Evaluation Criteria

Main Award Criteria

Proposals will be evaluated based on three main criteria: Excellence, Impact, and Implementation.
The threshold for each criterion is 4.
The cumulative threshold for all criteria is 12.

Key Scoring Factors (Indicative)

Relevance and Quality of Clinical Study: Proposals must include a Clinical study (Phase I, II, or I/II) and clearly detail it in the dedicated annex.
Economic Potential: Convincing demonstration of a significant economic potential of the final product(s) for the Single Market.
Exploitation Plan: A clearly defined exploitation plan, which should include:
- Detailed proposed route to commercialization.
- Description of intellectual property ownership.
- Clearly stated benefit for the SME(s) involved.
- An anti-shelving strategy.
- Commercial forecasts for product sales and revenue.
- Strategies for follow-up financing.
- Strategies for market authorization.
- The exploitation strategy should envisage a first deployment in the EU.
Patient Impact: Justification of the patient populations that will benefit directly from the therapies, with preference given to clinical indications where potentially large patient populations could benefit.

Special Considerations

Eligible proposals submitted under this topic and exceeding all evaluation thresholds will be awarded a STEP Seal.

Compliance & Special Requirements

Regulatory and Ethical Compliance

The investigational product must already have regulatory approval in the EU for phase I clinical study in place when applying.
Projects must adhere to ethical, legal, and regulatory considerations in health and care systems, ensuring ethically sound delivery and secure data handling.
Compliance with the EU Financial Regulation 2024/2509 and other relevant Horizon Europe general annexes (e.g., Annex C for financial and operational capacity, Annex D for evaluation criteria, Annex F for submission/evaluation processes, Annex G for legal/financial setup).

Technical and Operational Requirements

If using satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must use Copernicus and/or Galileo/EGNOS.
Proposals must clearly define intellectual property ownership within the exploitation plan.

Strategic and Special Considerations

STEP Seal Award: Proposals that exceed all evaluation thresholds will be awarded a STEP Seal, which aims to boost investments in critical technologies and enhance access to EU funding.
SME Focus: Emphasis on significant involvement of SMEs, with a requirement that at least 50% of the EU contribution goes to SMEs.
Single Market Impact: Projects must demonstrate a significant economic potential of the final product(s) for the European Single Market.
First Deployment in EU: The exploitation strategy should foresee the first deployment of the developed therapies in the EU.
Alignment with EU Strategies: The topic is driven by key Commission policies such as the 'Biotechnology and Biomanufacturing Strategy' and the 'Artificial Intelligence Strategy'. Proposals should align with these broader strategic objectives. This indicates a preference for projects leveraging AI in biotechnology.
Collaboration: Cooperation with relevant European research infrastructures is encouraged.

Grant Details