Establishing a European network of Centres of Excellence (CoEs) for Advanced Therapies Medicinal Products (ATMPs)

The Horizon Europe call, HORIZON-HLTH-2026-01-TOOL-07, focuses on establishing a European network of Centres of Excellence (CoEs) dedicated to Advanced Therapy Medicinal Products (ATMPs). The initiative, classified as a Coordination and Support Action (CSA), is designed to enhance Europe's capacity to develop and deploy innovative therapies, including gene therapies, cell therapies, and tissue-engineered products. The call targets existing institutions within vibrant bioclusters and will prioritize collaborative efforts among various stakeholders to address challenges in research, clinical trials, manufacturing, regulations, and market access.

The funding available is €3.9 million as a lump sum grant, allocated to one winning proposal that includes multiple consortium partners. The opportunity opens on February 10, 2026, with a submission deadline on April 16, 2026. Applicants must be based in EU Member States or Associated Countries, but entities from the United States can participate under specific provisions. The primary goal is to consolidate fragmented ATMP infrastructure across Europe, fostering a robust ecosystem that can better serve the innovation landscape.

Expected outcomes include developing a roadmap to make Europe a leader in ATMP research and innovation by 2035, identifying common research challenges, building an advisory board, and creating education and training programs. The network should embody a multi-faceted approach that encapsulates the entire ATMP value chain, from basic research to commercialization.

The proposal must demonstrate a plan for sustaining funding beyond the project period and articulate how it will align with the broader European Life Sciences strategy. Evaluation criteria emphasize excellence, impact, and practical implementation, with a cumulative threshold for success. While no mandatory co-funding is required, leveraging additional financial support is encouraged. Successful proposals might receive a STEP Seal, recognizing their alignment with strategic technology priorities.

In summary, this Horizon Europe initiative seeks to unify efforts across Europe to advance ATMPs, promote innovation, and ultimately improve patient access to cutting-edge treatments, emphasizing its significance in the evolving landscape of European healthcare and industry.

This is a Horizon Europe call, specifically HORIZON-HLTH-2026-01-TOOL-07, aiming to establish a European network of Centres of Excellence (CoEs) for Advanced Therapy Medicinal Products (ATMPs). It falls under Cluster 1 - Health (Single stage - 2026) of the Horizon Europe program. The action type is a HORIZON Coordination and Support Action (CSA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] mechanism. The call is forthcoming with a single-stage deadline model. The planned opening date is 10 February 2026, and the deadline for submission is 16 April 2026, 17:00:00 Brussels time.

The expected outcome is to support activities that enable or contribute to the impacts of "Developing and using new tools, technologies and digital solutions for a healthy society." This includes translating the "Strategy for European Life Sciences" into action, increasing the capacity and coordination of European ATMP infrastructures, boosting the European economy through ATMP innovations, and improving patient access to ATMPs across the EU.

The scope of the call addresses the fragmentation of ATMP centers across Europe, which limits the continent's attractiveness for R&D in this field. The goal is to create a coordinated European network of CoEs for ATMPs, building upon existing centers and aligning their development with national strategies. This network should enhance Europe's capacity to develop, scale up, and deploy ATMPs, making it more attractive for clinical research and supporting the European Life Sciences strategy. The CoEs are expected to support the development and manufacturing of ATMP-related biotechnologies.

Each CoE should be an existing center within a biocluster, benefiting from infrastructure like knowledge transfer support, GMP facilities, and clinical trial capabilities. They should conduct research from discovery to clinical trials and demonstrate leadership in the field. The network should consist of no more than 10 CoEs with complementary expertise.

The network should involve multiple stakeholders, including Member State ministries, regional representatives, funders, regulators, healthcare payers, industry, patient organizations, and policymakers. The European Commission's Joint Research Centre (JRC) can participate, contributing expertise in pre-normative research, standardization, and access to its research infrastructure.

To align with STEP eligibility, proposals should demonstrate contributions to either bringing innovative technologies to the internal market or reducing the Union’s strategic dependencies in advanced therapies.

The proposed projects should have a limited duration (2027-2030) and cover the following activities:

Identify common needs and challenges related to ATMP R&D and develop policy recommendations for clinical trials, manufacturing, logistics, regulatory harmonization, public acceptance, transnational care policies, and coordination with healthcare systems.
Develop a roadmap to make Europe a global leader in ATMP R&I by 2035, including milestones, targets, KPIs, alignment with national R&D plans, and a long-term funding strategy.
Create an advisory board with diverse stakeholders.
Develop common education and training programs for scientists and outreach activities to inform the public and stakeholders.

Proposals should build on previous actions like RESTORE, Join4ATMP, PRECISEEU, and T2EVOLVE, and liaise with partnerships such as the European Partnership on Rare Diseases, the European Partnership for Personalised Medicine, and the Innovative Health Initiative Joint Undertaking.

The admissibility conditions, proposal page limits, and layout are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes and Part B of the Application Form. Eligible countries are listed in Annex B of the Work Programme General Annexes. US legal entities can participate and receive Union funding. Project coordinators must be from an EU Member State or Associated Country. Projects using satellite data must use Copernicus and/or Galileo/EGNOS. The JRC can participate as a beneficiary with zero funding or as an associated partner.

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Eligible proposals exceeding evaluation thresholds will receive a STEP Seal. Award criteria, scoring, and thresholds are in Annex D of the Work Programme General Annexes. The thresholds for each criterion (Excellence, Impact, Implementation) will be 4, with a cumulative threshold of 12. Submission and evaluation processes are in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is also in Annex F.

Eligible costs will be in the form of a lump sum, as defined in the Decision of 7 July 2021. Legal and financial setups are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates, guidance documents, model grant agreements, and other additional documents are available in the Submission System and the Funding & Tenders Portal.

The budget overview lists several topics under the HORIZON-HLTH-2026-01 call, including their respective budgets, action types (RIA, CSA, IA, PPI), opening and deadline dates, contribution amounts, and indicative number of grants.

This funding opportunity aims to create a strong and coordinated European network of Centers of Excellence in the field of Advanced Therapy Medicinal Products. It seeks to consolidate existing expertise, promote innovation, and ultimately improve patient access to these cutting-edge treatments. The EU is investing in this area to become a global leader in ATMP research and innovation, fostering economic growth and addressing strategic dependencies in the healthcare sector. The call encourages collaboration among diverse stakeholders, including research institutions, industry, regulatory bodies, and patient organizations, to develop a roadmap for the future of ATMPs in Europe.

Eligible Applicant Types: The eligible applicant types include multiple stakeholders beyond the research community and/or established academic centres, including Member State ministries, regional representatives, funders, regulators and healthcare payers, industry actors, patient organisations and policymakers. The European Commission's Joint Research Centre (JRC) may participate as a member of the consortium selected for funding, bringing its expertise in pre-normative research, standardisation, regulatory advice and access to its research infrastructure. Coordinators of projects must be legal entities established in an EU Member State or Associated Country. 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. Each potential Centre of Excellence should be an existing centre embedded within a vibrant biocluster (i.e. within proximity to pharmaceutical companies and research institutes).

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant.

Consortium Requirement: A consortium of multiple applicants is required. The proposed European network of Centres of Excellence (CoEs) for ATMPs should include multiple stakeholders.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU Member States and Associated Countries. 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. 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.

Target Sector: The target sector is health, specifically focusing on Advanced Therapy Medicinal Products (ATMPs), biotechnologies, cell and gene therapy platforms, manufacturing infrastructure, and scale-up processes.

Mentioned Countries: United States of America, EU Member States, Associated Countries.

Project Stage: The project stage is focused on building on existing centres and coordinating their further development, suggesting a development and scale-up stage. Each potential CoE should be an existing centre.

Funding Amount: The funding amount is approximately €3,900,000.

Application Type: The application type is a single-stage open call.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process is a single-stage process.

Success Rates: Success rates are not explicitly mentioned, but there is an indicative number of 1 grant.

Co-funding Requirement: Co-funding requirements are not explicitly mentioned.

Summary:

This Horizon Europe call, HORIZON-HLTH-2026-01-TOOL-07, aims to establish a European network of Centres of Excellence (CoEs) for Advanced Therapy Medicinal Products (ATMPs). The goal is to strengthen Europe's capacity to develop, scale up, and deploy these innovative therapies, which include gene therapies, cell therapies, and tissue-engineered products. The call seeks to coordinate existing ATMP centres across the EU, fostering collaboration and addressing challenges related to R&D, clinical trials, manufacturing, regulations, and market access.

The selected project, funded as a HORIZON Coordination and Support Action (CSA) with a lump sum grant of approximately €3.9 million, should identify common needs and challenges in ATMP R&D, develop policy recommendations, create a roadmap for Europe to become a global leader in ATMP R&I by 2035, establish an advisory board, and develop education and training programs. The project should build on previous and ongoing actions and liaise with relevant partnerships.

Eligible applicants include a consortium of multiple stakeholders, such as Member State ministries, regional representatives, funders, regulators, healthcare payers, industry actors, patient organisations, policymakers, and research institutions. The European Commission's Joint Research Centre (JRC) may also participate. Coordinators must be legal entities established in an EU Member State or Associated Country, but legal entities from the United States of America may also participate and receive Union funding. The call opens on 10 February 2026, with a deadline of 16 April 2026.