Descrição

HORIZON-JU-GH-EDCTP3-2026-03-SERP-01

Expected Impact

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.

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:

1. 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.
2. 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.
3. Greater harmonisation, coordination and streamlining of research ethics processes within countries to allow for efficient processes for ethics review of multi-centre trials.
4. Greater alignment and cooperation across countries in SSA regarding global standards in ethics, regulatory and PV.
5. 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.

[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