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Grant Analysis

Purpose & Target

The core objective of this grant is to optimize the manufacturing processes for Advanced Therapy Medicinal Products (ATMPs), such as cell and gene therapies. This aims to accelerate access to these innovative treatments for healthcare providers, researchers, and patients. It targets academic and industrial developers, manufacturers, and companies in the health biotechnology sector. - Target recipient type: Broadly, legal entities, including academic institutions, industrial developers, and manufacturers. SMEs are strongly encouraged. - Target recipient size: Not explicitly restricted by size, but SMEs are encouraged. - This grant is SECTOR-SPECIFIC. - Geographic scope: Organisations established in EU Member States, Associated Countries, and the United States are eligible. International collaboration is generally open, but legal entities from China are excluded from Innovation Actions. - Key filtering criteria: Focus on ATMP manufacturing optimization, specific scope requirements, and consortium format. - Grant frequency: Part of the Horizon Europe 2025 Work Programme, suggesting it's an annual call as part of a recurring framework program.

Financial Structure

Funding for this topic (HORIZON-HLTH-2025-01-IND-01) will be provided as a lump sum contribution.
Minimum grant amount per project: EUR 6,000,000.
Maximum grant amount per project: EUR 8,000,000.
Total budget for this specific topic in 2025: EUR 40,000,000 (expected to fund 5 projects).
Currency: EUR.
Eligible costs: Lump sum is determined based on estimated direct and indirect project costs. It covers categories such as personnel, subcontracting, purchase costs (travel, equipment, other goods/services), and other specific costs.
Ineligible costs: Costs that would be ineligible under standard Horizon Europe rules should not be included in the lump sum estimation.
Indirect costs: A 25% flat rate for indirect costs is included in the calculation of the lump sum contribution.
Co-financing: The total estimated costs of the action must be greater than the estimated Union contribution, ensuring compliance with co-financing principles.
Payment schedule: Lump sum contributions are paid per work package, contingent upon the proper implementation of the work package activities as described in the grant agreement. Payments do NOT depend on actual costs incurred.
Financial reporting: Minimal; focus is on technical implementation and fulfillment of work package conditions. Beneficiaries are not required to document costs incurred for the action to the granting authority, but must adhere to national accounting practices.
A percentage (between 5% and 8%) of the total lump sum is retained as a contribution to the Mutual Insurance Mechanism.

Eligibility Requirements

Organizational Type & Structure

Eligible: Any legal entity that can participate in Horizon Europe, including academic institutions, industrial entities, and public bodies (like the JRC).
SMEs are strongly encouraged to participate.
A consortium is required, as it is an Innovation Action.
Legal entities established in the United States of America are eligible to receive Union funding.

Geographic Requirements

Eligible countries: EU Member States, Associated Countries, and the United States.
All topics are open to international collaboration, unless specifically excluded.

Exclusion Criteria

Legal entities established in China are NOT eligible to participate in Innovation Actions (like this one) in any capacity.
Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and any entities they own or control) are NOT eligible to participate as beneficiaries, affiliated entities, or associated partners.

Application Process

Application Procedure

This call operates on a single-stage submission process.
Applications must be submitted through the electronic submission system on the Funding & Tenders Portal.

Application Timeline

Planned Opening Date: 2025-05-22
Submission Deadline: 2025-09-16 00:00:00+00 (Brussels time)

Required Documentation and Materials

Standard application form (HE RIA, IA) – specific to this call and available in the Submission System.
Detailed budget table (HE LS) – required for lump sum grants.
For proposals including clinical studies, a dedicated annex using the provided template must be completed.

Support and Guidance

Online Manual: Provides guidance on proposal submission, evaluation, and grant management.
Horizon Europe Programme Guide: Detailed guidance on the structure, budget, and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ: Answers to common questions.
National Contact Points (NCPs): Guidance, practical information, and assistance on participation in Horizon Europe.
Enterprise Europe Network (EEN): Advice for businesses, especially SMEs, on EU research funding.
IT Helpdesk: For technical issues related to the Portal.
European IPR Helpdesk: Assistance on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: Advice on standardisation in project proposals.
Partner Search: Tool to find partner organisations for proposals.

Post-Award Requirements

Implementation of the action will be monitored based on technical progress and fulfillment of work package conditions.
Progress tracking mechanisms will focus on technical implementation, research integrity, dissemination, exploitation of results, IP management, and gender equality.

Evaluation Criteria

Proposals will be evaluated based on three main criteria: Excellence

Quality of the proposed research and innovation activities.
Soundness of the methodology.

Impact

Credibility of the pathway to achieve the expected impacts of the 'Maintaining an innovative, sustainable, and competitive EU health industry' destination.
Contribution to fostering a more competitive and sustainable European health industry, ensuring leadership in breakthrough health technologies, and strategic autonomy in essential medical supplies.
Ability to facilitate swift uptake of innovative health technologies and services, providing evidence and guidelines for stakeholders and policymakers.
Potential for increased health security in Europe and Associated Countries through reliable access to key manufacturing capacity.

Quality and Efficiency of the Implementation

Quality and effectiveness of the work plan, including the appropriateness of the allocation of tasks and resources.
Appropriateness of the management structures and procedures.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact), and 4 (Implementation). The cumulative threshold will be 12.
Experts with financial knowledge will check the budget estimate against benchmarks to ensure resources and lump sum shares align with activities and expected outputs.

Compliance & Special Requirements

Regulatory Compliance

Projects must consider and assess the regulatory validity and utility of developed processes, engaging with regulators in a timely manner.
Alignment with the EU regulatory context for Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) is important.
Support for the Pharmaceutical Strategy for Europe is expected.

Environmental Standards

Proposals should promote green and sustainable industrial production and aim to minimize environmental impact.

Data Protection and Security

When integrating digital or AI solutions, proposals must consider security and data protection requirements (e.g., cybersecurity).

Intellectual Property

The management of intellectual property is an important aspect of grant implementation and may be subject to checks.

Ethical Standards

Compliance with ethical standards and research integrity principles is required and will be a focus for checks.

Special Considerations

Innovation Action (IA): The grant focuses on activities closer to market uptake, building on established (though unoptimized) manufacturing processes.
Lump Sum Funding: Payments are based on completion of work packages, simplifying financial reporting but requiring clear work package definitions and deliverables.
SME Engagement: Strong encouragement for small and medium-sized enterprises (SMEs) to participate, and a commitment for first deployment of results in the EU is expected.
Collaboration: Proposals are encouraged to liaise with the Coordination and Support Action (CSA) project JOIN4ATMP for complementarities and synergies.
JRC Involvement: The Joint Research Centre (JRC) may participate in consortia and may collaborate with successful proposals, offering expertise in research-to-regulation interface and pre-normative science.

Grant Details