Training and innovation networks for sustained capacity development related to ethics, regulatory, pharmacovigilance, and related digital regulatory p...

The HORIZON-JU-GH-EDCTP3-2026-03-SERP-01 grant opportunity, under the European Union’s Horizon Europe program, has a budget of €15 million aimed at improving ethics, regulatory systems, and pharmacovigilance in sub-Saharan Africa through strategic capacity building and innovation in health systems. This initiative targets the establishment of training networks and innovation partnerships to bolster regulatory capacity, emphasizing digital health solutions and the application of artificial intelligence.

Eligibility is limited to consortiums composed of at least three independent legal entities from different eligible countries, including members from EU Member States, associated countries, and sub-Saharan African nations affiliated with the EDCTP Association. The program specifically emphasizes multi-country collaborations that incorporate at least one entity from both Europe and sub-Saharan Africa, promoting South-North-South partnerships.

The funding will be dispensed as fixed lump sum grants of €1.5 million per project, avoiding traditional cost reimbursement for greater flexibility in project budgeting. The application process features a single-stage submission model, with an opening date of January 14, 2026, and a deadline of September 2, 2026.

Key objectives of the grant include enhancing the regulatory landscape for clinical trials, marketing authorization, and pharmacovigilance, aiming for compliance with WHO Maturity Level 3 standards. Proposals should offer innovative solutions to existing weaknesses in ethics and regulatory frameworks, including digital health infrastructure and the harmonization of regulations across multiple countries.

Expected outcomes include improved oversight capacities, efficient review processes for clinical trials, and enhanced collaboration among regulatory bodies within the region. Co-funding from external sources is encouraged to amplify the reach and impact of the projects, although it is not a formal requirement.

This funding opportunity aligns with the EU's broader commitment to elevating global health research standards in Africa, addressing health security challenges, and fostering equitable partnerships between European and African institutions. Successful proposals will contribute to a more resilient health system capable of managing contemporary health challenges in sub-Saharan Africa.

This is a call for proposals under the Horizon Europe program, specifically targeting the Global Health EDCTP3 Joint Undertaking (JU). The call, HORIZON-JU-GH-EDCTP3-2026-03-SERP-01, aims to establish training and innovation networks for sustained capacity development in ethics, regulatory affairs, pharmacovigilance (PV), and related digital regulatory platforms in sub-Saharan Africa (SSA). The call is structured as a Coordination and Support Action (CSA) and will utilize a HORIZON Lump Sum Grant agreement.

The overall budget allocated for this topic is 15,000,000 EUR, and it is anticipated that approximately 10 grants will be awarded. The call follows a single-stage submission process, with the opening date set for January 14, 2026, and the deadline for submissions on September 2, 2026, at 17:00 Brussels time.

The expected impact of funded actions is the establishment of a resilient and future-ready ethics, regulatory, and PV environment in SSA through strategic capacity building, digital transformation, and cooperation. Applicant consortia can request technical support from the EDCTP Association for proposal preparation, especially considering the lump sum nature of the grant agreement. Consortia may also include the EDCTP Association as a coordinator.

The background highlights the challenges faced by ethics bodies, regulatory agencies, and PV systems in SSA, including limited resources, training, digital infrastructure, and regulatory alignment. Initiatives like AVAREF, AMRH, and AMA have been launched to address these gaps, with support from international bodies like the WHO. Despite progress, hurdles remain, such as a lack of harmonized standards, underfunded committees and agencies, and disparities in capacity.

The expected outcomes of successful proposals include increased regulatory capacity for clinical trial oversight, registration, marketing authorization, and PV functions, aiming for WHO maturity level 3 (ML3) as benchmarked against WHO Global Benchmarking Tool. Increased research ethics oversight capacity using the WHO Research Ethics Oversight Benchmarking tool, 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: Improved digital infrastructure including emerging digital technologies (i.e. AI and/or big data) in SSA for the assessment of clinical trial protocols by RECs and/or regulatory authorities and/or applications for marketing authorisation by regulatory authorities. Availability and accelerated use of digital technologies and data analytics, for real-time safety data monitoring and reporting, and timely PV data sharing across countries in SSA and globally through PIDM, for pre- and post-authorisation PV processes. Greater harmonisation, coordination and streamlining of research ethics processes within countries to allow for efficient processes for ethics review of multi-centre trials. Greater alignment and cooperation across countries in SSA regarding global standards in ethics, regulatory and PV. Greater preparedness for emergency use authorisation [incl. authorisation of Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI)] through implementation of accelerated and harmonised processes.

The scope of proposals should address persistent gaps in ethics, regulatory, and/or PV systems by strengthening existing or building new networks. 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. 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.

In addition, proposals should address minimum one of the below: Building national and/or regional/continental ethics and regulatory capacity to utilise digital technologies, improving the review and approval processes and knowledge of clinical trial applications (including acceleration through parallel ethics and regulatory review), and/or marketing authorisation of medicinal products. Improving integration of PV systems into national health systems by building and utilising digital reporting mechanisms and data sharing across countries in SSA in alignment with international standards: Implementation of collaborative digital platforms for accelerated use of digital reporting mechanisms to support joint reviews and collaboration in PV, enabling more efficient sharing of data on Adverse Drug Reactions (ADRs) from site to national systems and beyond national (e.g., WHO Programme for International Drug Monitoring (PIDM)) and/or Improve safety reporting by improving the quality of the adverse event reports as well as enhancing the geographical coverage of the reported data, and/or Strengthen pre- and post-authorisation PV systems including risk-benefit analysis. Improving regulatory and ethics framework and infrastructure for emergency preparedness: Harmonisation of processes, fostering reliance, implementation and use of digital collaboration platforms to support joint reviews. Establishing continental and global ethics and regulatory peer support and twinning networks. Establishing continental and global regulatory innovation networks working on alternative pathways for licensure and on the vision of “ONE WORLD, ONE DOSSIER”.

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. 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 activities include 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. 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) are encouraged. The granting authority will 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.

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.

The admissibility conditions include adherence to proposal page limits and layout guidelines as 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, with specific provisions for non-EU/non-Associated Countries.

Other eligibility conditions include specific requirements for the Global Health EDCTP3 JU funding, consortium composition, and the designation of a scientific project leader if the coordinator is not established in a country in SSA. The consortium must include at least three independent legal entities from different eligible countries, with at least one from a Member State or associated country that is a member of the EDCTP Association, and at least one from a sub-Saharan African country that is a member of the EDCTP Association.

Financial and operational capacity and exclusion criteria are described in Annex C of the Work Programme General Annexes. The award criteria, scoring, and thresholds are detailed in Annex D of the Work Programme General Annexes. The submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is also outlined in Annex F.

Legal and financial aspects of the grants include the possibility for beneficiaries to provide financial support to third parties, with a maximum amount of EUR 60,000 per third party. Eligible costs will take the form of a lump sum, as defined in the Decision of 7 July 2021. Global Health EDCTP3 retains the right to object to the transfer or exclusive licensing of results for up to four years after the end of the action.

Applicants should be aware that information regarding their proposals may be shared with members of the JU Committee of the EDCTP Association. Global Health EDCTP3 may invite contributing partners to participate in the evaluation process as observers.

For all projects under this topic, if the coordinator is not from a country in SSA, the designation of a scientific project leader is mandatory.

The call provides templates for application forms and evaluation forms, as well as guidance documents such as the HE Programme Guide, Model Grant Agreements, and call-specific instructions.

This funding opportunity aims to strengthen ethics, regulatory, and pharmacovigilance systems in sub-Saharan Africa. It seeks to build capacity through training, innovation networks, and digital transformation, ultimately leading to improved healthcare service delivery, safety reporting, and timely approval of medical products. The program encourages collaboration between European and African institutions, promoting a more resilient and efficient healthcare ecosystem in the region.

Eligible Applicant Types: The eligible applicant types are legal entities. 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), Curacao (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthelemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR); Countries associated to Horizon Europe: 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, 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: Benin, Burkina Faso, Burundi, Cameroon, Cote 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.

Funding Type: The funding type is a grant, specifically a HORIZON JU Coordination and Support Action (HORIZON-JU-CSA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] Model Grant Agreement.

Consortium Requirement: A consortium is required. 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.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes Member States of the European Union and their outermost regions, Overseas Countries and Territories (OCTs) linked to the Member States, Countries associated to Horizon Europe, and the constituent states of the EDCTP Association which are sub-Saharan African countries.

Target Sector: The target sectors are health, digital health, ethics, regulatory affairs, and pharmacovigilance (PV). Specifically, the program targets capacity building in ethics, regulatory systems, and pharmacovigilance in sub-Saharan Africa, with a focus on digital transformation and the use of AI and big data.

Mentioned Countries: 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, Aruba, Bonaire, Curacao, French Polynesia, French Southern and Antarctic Territories, Greenland, New Caledonia, Saba, Saint Barthelemy, Sint Eustatius, Sint Maarten, St. Pierre and Miquelon, Wallis and Futuna Islands, Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Serbia, Republic of Korea, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom, Egypt, Morocco, Benin, Burkina Faso, Burundi, Cameroon, Cote 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.

Project Stage: The project stage is capacity building, focusing on scaling and sustaining existing efforts, establishing training and innovation networks, and developing a robust digital health ecosystem. The projects aim to bring regulatory authorities to WHO maturity level 3 (ML3).

Funding Amount: The funding amount is approximately EUR 2,250,000 per grant for HORIZON-JU-GH-EDCTP3-2026-03-DIGIT-02, with a total budget of EUR 18,000,000, and approximately EUR 1,500,000 per grant for HORIZON-JU-GH-EDCTP3-2026-03-SERP-01, with a total budget of EUR 15,000,000.

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. Financial support to third parties is also possible, up to EUR 60,000 per third party.

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

Success Rates: The indicative number of grants suggests a success rate of approximately 8 out of the total number of applications for HORIZON-JU-GH-EDCTP3-2026-03-DIGIT-02 and 10 out of the total number of applications for HORIZON-JU-GH-EDCTP3-2026-03-SERP-01. The exact success rate will depend on the number of applications received.

Co-funding Requirement: The need for co-funding is not explicitly mentioned, but financial contributions from third parties (e.g., foundations) are encouraged to increase the budget, diversity, and impact of the projects.

This opportunity is a call for proposals under the Horizon Europe program, specifically targeting the Global Health EDCTP3 Joint Undertaking. It aims to strengthen ethics, regulatory, and pharmacovigilance (PV) systems in sub-Saharan Africa (SSA) through strategic capacity building, digital transformation, and cooperation. The call encourages the establishment of training, twinning, and innovation networks to bolster workforce capacity and harmonize processes. A key focus is the development of a robust digital health ecosystem, including the use of AI and big data, to enhance the efficiency and responsiveness of ethics, regulatory, and PV frameworks. The goal is to increase the regulatory capacity of authorities in SSA, enabling them to operate at WHO maturity level 3 (ML3). The call expects proposals to address persistent gaps in ethics, regulatory, and PV systems, improve digital infrastructure, promote data sharing, and enhance emergency preparedness. Research consortia with strong representation from SSA countries, including Franco/Lusophone institutions, are particularly encouraged to apply. The funding will be provided as a lump sum grant, and financial support to third parties is possible.