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This round is closed. The next round and similar open calls are listed below. Synced from the EU Funding & Tenders Portal on 9 November 2026.
This call is closed. These open or upcoming calls fund the closest work.
Based on projects the EU funded on the same subject in this programme.
FORTIFYFORTIFY - FRAMEWORK FOR OPTIMIZED REGULATION, TRADE SECRETS, AND INTELLECTUAL PROPERTY IN A FEDERATED EUROPEAN HEALTH DATA SPACE
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PROBEPatient Relevant Osteoarthritis endpoints using Big data Evaluation
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IMPROVEFramework to IMPROVE the Integration of Patient Generated Health Data to Facilitate Value Based Healthcare
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MAGNETSMalaria Genomic Epidemiology and Biostatistics Network for Enhancing Talent in Sub-Saharan Africa
HORIZON-JU-GH-EDCTP3-2025-02-FELLOW-01-two-stage · 2026 · Official record ↗
AFRITRACAFRICAN TRAINING NETWORK FOR BIOSTATISTICS, EPIDEMIOLOGY AND INFECTIOUS DISEASE MODELLING
HORIZON-JU-GH-EDCTP3-2025-02-FELLOW-01-two-stage · 2026 · Official record ↗
The PHM HubA Public Health Modelling & Data Science Fellowship Centre of Excellence in West and Central Africa
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SPHERE-AfricaSTRENGTHENING PUBLIC HEALTH EDUCATION IN RESEARCH & EPIDEMIOLOGY IN AFRICA (SPHERE-AFRICA)
HORIZON-JU-GH-EDCTP3-2025-02-FELLOW-01-two-stage · 2026 · Official record ↗
SkincAIrEarly detection and management of SKIN-related negleCted tropical diseases using Artificial Intelligence in sub-saharan afRica (SkincAIr)
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Each one links to its EU funding record and the partners it works with: a starting list for building a consortium.
Through strategic capacity building, digital transformation, and cooperation in SSA, the actions funded under this topic should contribute to the establishment of a resilient and future-ready ethics, regulatory and PV environment.
Applicant consortium
If requested by the applicant consortia, the EDCTP Association may offer technical support for the preparation of their proposal, in particular because of the lump sum nature of the Grant Agreement. The applicant consortia may also decide to include the EDCTP Association as coordinator. In that case, the applicant consortia should contact the EDCTP Association to obtain the estimated amount of the Association’s contribution as well as any other relevant information. The EDCTP Association will timely provide the necessary information to all potential applicants.
Background
Ethics bodies, regulatory agencies, and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) continue to face significant challenges that hinder effective provision of healthcare services, safety reporting and timely regulatory approval for clinical trials, and marketing authorisation of products. These challenges are largely attributed to limited resources, limited training provision and access to mentor expertise, governance constraints, disparities in digital infrastructure, and limited regional and international regulatory alignment. In response, initiatives such as the African Vaccines Regulatory Forum (AVAREF), the African Medicines Regulatory Harmonization (AMRH) Programme and most recently the African Medicines Agency (AMA) have been launched to address these gaps. International bodies, including the World Health Organization (WHO), along with partnerships in SSA, have contributed to bridge the gap by offering technical support, training, and resources to strengthen ethics, regulatory and PV capacities. Public-private partnerships have further supported ethics and regulatory capacity strengthening, safety monitoring systems, including the development and integration of digital health technologies to enhance adverse event monitoring and reporting, and to accelerate the regulatory submission and assessment processes through collaborative or joint reviews.
As per the WHO publication of October 2025[1], eight SSA National Regulatory Authorities (NRAs)—Ghana, Nigeria, South Africa, Tanzania, Rwanda, Senegal, and Zimbabwe—are classified by WHO as Maturity Level 3 (ML3), indicating reasonably established and functioning regulatory systems. Nevertheless, major hurdles remain, such as the lack of harmonised regulatory standards and timelines, underfunded research ethics committees (RECs) and NRAs, disparities in institutional and digital capacity and sustainability of the systems set up. These issues hinder the timely and consistent evaluation of research protocols and/or applications for marketing authorisation for diagnostics, medicines, and vaccines across the region.
Despite the increasing participation of SSA countries in the WHO Programme for International Drug Monitoring (WHO PIDM), PV systems in many SSA countries remain underdeveloped and insufficiently integrated into national healthcare systems. This is reflected on both pre- and post-authorisation safety monitoring, where systems are weakened by poor digital infrastructure, limited laboratory capacity for confirmation of suspected events, weak reporting tools for data capture and interpretation, and a shortage of trained personnel. This limits the region’s ability to ensure effective PV and safety of medicinal products.
Building on the progress made through previous EDCTP initiatives[2], this call aims to scale and sustain these efforts by establishing training, twinning, and innovation networks, leveraging existing networks where applicable that will bolster workforce capacity in ethics, regulatory, and PV and harmonisation of processes and timelines. Central to this approach is the development of a robust digital health ecosystem, which will allow seamless collaboration and enhance the operational efficiency and responsiveness of ethics, regulatory, and PV frameworks through the integration of data-driven technologies and digital infrastructure, including artificial intelligence (AI) when considered appropriate, catalysing the approval and implementation of health solutions in SSA.
Expected Outcomes
Proposals submitted under this topic should aim to deliver results that are contributing to increased regulatory capacity of (national, regional (supranational) or continental) Regulatory Authorities for the clinical trial oversight, registration and marketing authorisation and/or PV functions to operate at WHO maturity level 3 (ML3) as benchmarked against WHO Global Benchmarking Tool[3] for medical products (therapeutics and vaccines) and/or increased research ethics oversight capacity using the WHO Research Ethics Oversight Benchmarking tool[4] including streamlining and coordinating ethics oversight for multi-centre trials for medical products (therapeutics and vaccines) within countries.
In addition, proposals are expected to lead to at least two of the following:
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:
In addition, proposals should address minimum one of the below:
Proposals should ensure capacity building across countries in SSA, including a leadership development program such as training of trainers for ethics capability building, and knowledge sharing across countries in SSA.
Proposals should address how to increase awareness and development of policy on data protection in the context of storage of data when relevant.
Proposals are encouraged to consider capacity strengthening strategies that align with the One Health Approach[5].
Proposals are encouraged to address relevant ethics, legislative and regulatory gaps most pertinent to the SSA countries for strengthening the (digital) platform and to extend the region covered addressing regional/continental needs.
Proposals are encouraged to ensure that ethics and regulatory capacity strengthening are well aligned and progress in parallel.
Applicants should provide methodologies for translating research findings into public health practice and policy guidelines and are encouraged to follow guidance provided in the EDCTP Knowledge Hub Research into Policy Toolkit.
Proposals should engage communities and relevant stakeholders, most notably (local) key opinion leaders, researchers or clinical Investigators, health care professionals, policy makers, public health authorities and end-users.
Out of scope: Capacity building related to Manufacturing activities for pharmaceutical/vaccines products including but not limited to batch release, support for local manufacturing of active pharmaceutical ingredients (APIs) and Technology Transfer, diagnostic production, financing, strategic and policy Support Mechanisms for manufacturing are out of the scope of this topic. However, the scope includes strengthening of NRAs capacity to carry out manufacturers inspections enabling registration and marketing authorization of medical products.
Financial contributions from third parties (e.g., foundations) interested in this scheme are encouraged to contribute to increase the budget, diversity and impact. The purpose of this topic is to fund different regions and varied portfolio of ethics, regulatory and PV projects. The granting authority will therefore base its funding decision relevant to this topic on the ranking of the proposals considering diversity of the geography and topics (Ethics/Regulatory/PV) in the proposals that are graded above the threshold.
Activities such as willingness to enter into technology transfer agreements with their counterparts - including the provision of patents, technical knowledge and know-how, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market to be done in collaboration and coordination, when possible, with the AU-EU Health Partnership’s Manufacturing and Access to Vaccines, medicines and health technologies (MAV+) hub or similar African initiatives are encouraged to be done outside the scope of this topic.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from SSA countries, including active participation of Franco/Lusophone institutions. Collaboration with other international research groups with relevant experience is very much encouraged.
Proposals should include the development or implementation of common indicators (e.g., WHO benchmarking data tools) in assessing the status and functioning of Ethics Committees or Regulatory Authorities towards alignment with global standards.
[1] List of National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4)
[2] EDCTP1-Project-Portfolio-2003-2015.pdf; EDCTP2-Project-Portfolio
[3] WHO | Global Benchmarking Tools
[4] WHO | Benchmarking tool for ethics oversight of health-related research in humans
[5]
1. Admissibility Conditions: Proposal page limit and layout
described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.
2. Eligible Countries
described in Annex B of the Work Programme General Annexes.
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. See the information in the Horizon Europe Programme Guide.
3. Other Eligible Conditions
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:
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:
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:
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.
4. Financial and operational capacity and exclusion
described in Annex C of the Work Programme General Annexes.
5a. Evaluation and award: Award criteria, scoring and thresholds
are described in Annex D of the Work Programme General Annexes.
5b. Evaluation and award: Submission and evaluation processes
Specific conditions related to Scores and weighting
Replacing the scores and weighting section in General Annex D to the Horizon Europe Work Programmes as regards second stage of two-stage evaluations, for Research and Innovation Actions (RIA). Evaluation scores will be awarded for the criteria, and not for the different aspects listed in the table. For full applications, each criterion will be scored out of 5. The threshold for individual criteria 1 (Excellence) and 2 (Impact) will be 4 and for criterion 3 (Quality and Efficiency of the implementation) will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12.
Proposals that pass the individual threshold and the overall threshold will be considered for funding, within the limits of the available call budget. Other proposals will be rejected.
Nota bene: for the CSAs and the first stage of the two-stage evaluation of RIAs, the scores and weighting as indicated in Annex D of the General Annexes of the Horizon Europe work programme 2023/2025 apply.
are described in Annex F of the Work Programme General Annexes and the Online Manual.
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement
described in Annex F of the Work Programme General Annexes.
6. Legal and financial set-up of the grants
Beneficiaries may provide financial support to third parties. The support to third parties can only be provided in the form of grants. The maximum amount to be granted to each third party is EUR 60.000.
The relevant provisions of the Model Grant Agreement will apply.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
described in Annex G of the Work Programme General Annexes.
JU right to object to transfer/exclusive licensing
Global Health EDCTP3 may, up to four (4) years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5 of the Model Grant Agreement. In addition, in accordance with Article 24(3) of Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe and the Model Grant Agreement, the right to object applies also to participants that have not received funding from the JU.
[1] 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.
Information sharing regarding the proposals and the evaluation results
Applicants should be aware that the following information regarding their proposals may be shared with the members of the JU Committee of the EDCTP Association:
1. Following eligibility check of the applications: aggregated country level data i.e. number of applicants, funding requested, organisation type;
2. For successful proposals, following Global Health EDCTP3 Governing Board decision on the call evaluation results: number; acronym; title; duration; role; country; legal name; PIC; legal type; total cost; requested JU contribution;
3. Regarding project information following Grant Agreement (GA) signature: signature date of the GA; number, acronym, title, and duration of projects; role, country, legal name, PIC, legal type, URL, total cost, requested JU contribution, FC received, FC given, and IKOP of participants;
4. Under specific conditions and following Global Health EDCTP3 Governing Board approval of the request of EDCTP Association, for proposals on the reserve list and unsuccessful proposals: number; acronym; title; duration; role; country; legal name; PIC; legal type; total cost; requested JU contribution.
Access to information and involvement of contributing partners
Evaluation
To promote transparency and accountability, Global Health EDCTP3 may invite any contributing partners providing financial contributions under a certain topic to propose one representative as observer to participate in the evaluation process under confidentiality safeguards. This possibility does not apply to contributing partners that are part of a consortium submitting a proposal under the relevant topic.
Documents and information
By applying under any topic, participants consent that the JU reserves the right to share information and documents relevant to their application and where applicable their grant agreement and its implementation with contributing partners as identified and providing financial contributions under the relevant topic. This information and documentation will only be shared under confidentiality safeguards for policy and monitoring purposes. They include:
Global Health EDCTP3 may consult the relevant contributing partners for the purpose of assessing the project reports and deliverables.
Other requirements
For all projects under this topic, if the coordinator is not from a country in SSA, the designation of a scientific project leader with the roles as described in the introduction is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
Annual Work Programme 2026
Global Health EDCTP3 Calls for proposals
Application and evaluation forms and model grant agreement (MGA):
Application form templates — the application form specific to this call is available in the Submission System
Standard application form (HE CSA)
Evaluation form templates — will be used with the necessary adaptations
Standard evaluation form (HE CSA) 
Guidance
HE Programme Guide 
Model Grant Agreements (MGA)
HE MGA 
Lump Sum MGA 
Call-specific instructions 
Detailed budget table (HE LS) 
Information on financial support to third parties (HE) 
Information on clinical studies (HE) 
Guidance: "Lump sums - what do I need to know?"
Additional documents:
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 4. Health
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Programme Guide
HE Framework Programme 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual 
Funding & Tenders Portal Terms and Conditions 
Funding & Tenders Portal Privacy Statement
Confirm the current call documents and submission conditions with the funding authority.
View on EU portal ↗Source: EU Funding & Tenders Portal · synced 2026-11-09
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