The Global Health EDCTP3 Joint Undertaking (GH EDCTP3) builds on the first and second European and Developing Countries Clinical Trials Partnership programmes. This new joint undertaking (JU) is a partnership between the EU and the EDCTP Association, whose members are several European and African countries. The partnership will deliver new solutions for reducing the burden of infectious diseases in SSA and strengthen research capacities to prepare and respond to re-emerging infectious diseases in this region and across the world.

Proposals submitted under this topic should address persistent gaps in ethics, regulatory and/or PV systems evaluating medical products (therapeutics and vaccines) by strengthening existing and/or building new networks:

1. Proposals should address the capability to provide scientific advice, enhancement of knowledge on assessing complex innovative clinical trial applications (included but not limited to platform trials) and/or assessing marketing authorisation files, and/or PV capabilities including AI and big data as appropriate, strengthening capacity for ethics committees and/or regulatory agencies that did not reach ML3 for the corresponding areas as defined in the WHO Global Benchmarking Tool, while benefitting from mentoring/peer support by ML3/ML4 agencies as part of the consortium.
2. Proposals should establish and strengthen training and twinning networks or a regional regulatory authority dedicated to training ethicists and regulators to ensure sustainable capacity for Ethics Committees, and/or Regulatory Authorities and/or PV across countries in SSA in alignment with international standards.

Expected EU contribution per project €1.500.000 (Number of proposals -10)

• Health
• Research, Technological Development and Innovation

• Legal Entities
• Other Beneficiaries
• Private Bodies
• Researchers/Research Centers/Institutions

The conditions are described in General Annex B except for the specific conditions for the Global Health EDCTP3 JU funding as regards entities eligible for funding and consortium composition, the specific rule for countries where the coordinator may be established and the obligation to designate a scientific project leader as below.

Specific conditions replacing the relevant sections in General Annex B to the Horizon Europe Work Programmes

A. Entities eligible for funding

This section applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA).

To become a beneficiary, legal entities must be eligible for funding. 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: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
• The Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR);
• Countries associated to Horizon Europe[[The list is correct at the time of adoption of this work programme. Please see the Horizon Europe List of Participating Countries on the Funding & Tenders Portal for up-to-date information on the current list and on the position for Associated Countries: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf]]: Albania, Armenia, Bosnia and Herzegovina, Canada (associated to Pillar II ‘Global Challenges and European Industrial Competitiveness’, including for the institutionalised European partnerships, and for award procedures implementing Union budget for the year 2024 and onwards), Faroe Islands, Georgia, Iceland, Israel, Kosovo[[This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.]], Moldova, Montenegro, New Zealand (associated to Pillar II ‘Global Challenges and European Industrial Competitiveness’ as from the Work Programmes 2023 onwards, including for the institutionalised European partnerships), North Macedonia, Norway, Serbia, Republic of Korea (Pillar II only), Switzerland, Tunisia, Turkey, Ukraine, United Kingdom;
• Until association agreements start producing legal effects either through provisional application or their entry into force, transitional arrangements apply. The transitional arrangements apply, at the time of the adoption of this Work Programme, with regard to the following countries and legal entities established in these countries, with which association negotiations are being processed or where association is imminent): Egypt, Morocco, .
• The following countries which are constituent states of the EDCTP Association[[The list is correct at the time of adoption of this work programme. For an update, please check the EDCTP Association website www.edctp.org.]]: Benin, Burkina Faso, Burundi, Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Eswatini, Gabon, The Gambia, Ghana, Guinea-Bissau, Guinea-Conakry, Kenya, Liberia, Malawi, Mali, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Senegal, Sierra Leone, Somalia, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.

Legal entities which are established in countries not listed above (including in low-and middle-income countries that are not members of the EDCTP Association) will be eligible for funding if provided for in the specific call topic conditions, or if their participation is considered essential for implementing the action by the granting authority.

B. Consortium composition

Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of Global Health EDCTP3, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes as beneficiaries:

• At least three legal entities independent from each other and each established in a different country, where legal entities are eligible to receive funding;
• At least one independent legal entity established in a Member State, or in an associated country to Horizon Europe that is a member of the EDCTP Association; and
• At least one independent legal entity established in a sub-Saharan African country that is a member of the EDCTP Association.

This condition applies to both Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA).

For the two CSA (2) topics under call HORIZON-JU-GH-EDCTP3-2026-03 in case the applicant consortia opt for including the EDCTP Association as coordinator, the EDCTP Association must not be counted as one of the three independent legal entities necessary to ensure the eligibility of the consortium composition.

Specific cases:

Affiliated entities — Affiliated entities are eligible for funding under the same conditions as beneficiaries.

Associated partners — Entities not eligible for funding and therefore not able to participate as beneficiaries or affiliated entities (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.

International organisations – International European research organisations are eligible to receive funding. Other international organisations are not eligible to receive funding unless their participation is considered essential for implementing the action by the granting authority. International organisations with headquarters in a Member State or associated country are eligible to receive funding when provided for in the specific call conditions.

Specific rules regarding legal entities that may be the coordinator of an indirect action

In accordance with Article 110(2) of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[[Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014, p. 17–119.]], where entities established in a third country without an agreement to protect the financial interests of the Union participate with funding in an indirect action, the coordinator of the indirect action must be established in a Member State or associated country, or South Africa.

Scientific project leader

If the coordinator is not established in a country in SSA (please see previous paragraph), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described below is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity. The scientific project leader oversees the project scientific governance and leadership. For this purpose, proposals must include a work package where the details of scientific project leadership are laid down. The scientific project leader should indicatively perform the following tasks:

• During the call for proposals and selection process, coordinate meetings on and drafting of the full project proposal.
• Work with the coordinator and other beneficiaries on the drafting and negotiation of the consortium agreement and other legal agreements among the beneficiaries.
• Act as the key contact point for the Global Health EDCTP3 JU regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, without prejudice to the tasks entrusted directly to the coordinator as per the Model Grant Agreement.
• Support and collaborate with the coordinator on its monitoring activities and the adoption of appropriate internal measures, to ensure that beneficiaries are fulfilling their obligations regarding budget, timeline, deliverables, and scientific quality.
• Review the action’s deliverables and reports before their submission by the coordinator.
• Lead the work packages(s) related to the tasks of scientific project leadership.

Annex 1 to the grant agreement and the consortium agreement should address the relationship of the scientific project leader with the coordinator regarding their respective tasks, for example sharing of the information received from or sent to Global Health EDCTP3 on all issues of interest for the proper scientific management of the action.

The applicant consortia may opt for including in their proposal the EDCTP Association as coordinator.

In such a case, the eligible costs of the EDCTP Association in the actions funded under this topic will not be reimbursed by the JU and may be used as a basis for in-kind contributions to operational activities (IKOP). The in-kind contribution of the EDCTP Association will cover the coordination activities of the project. In case applicant consortia decides to include the Association as coordinator, they should contact the EDCTP Association in order to inform the Association on their decision and obtain the estimated amount of the Association’s contribution as well as any other relevant information. The EDCTP Association will timely provide the information to all potential applicants.

The EDCTP Association must not be counted as one of the three independent legal entities necessary to ensure the eligibility of the consortium composition, as requested in the Call conditions, “Specific conditions to Global Health EDCTP3 JU – B. Consortium composition”.

described in Annex B of the Work Programme General Annexes.

EDCTP – Europe Office
Postal and visiting address: Anna van Saksenlaan 51, 2593 HW The Hague, The Netherlands
Telephone: +31 70 344 0880

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• GH EDCTP3 - WP 2026 (Global Health EDCTP3 Work Programme 2026
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