Training and Innovation Networks for Ethics, Regulatory and Pharmacovigilance Capacity

About the call The Global Health EDCTP3 Joint Undertaking has opened a Coordination and Support Action (CSA) call (call reference HORIZON-JU-GH-EDCTP3-2026-03-SERP-01) to build sustained ethics, regulatory and pharmacovigilance (PV) capacity for the evaluation of medical products in sub-Saharan Africa.

The call funds training, twinning and innovation networks that strengthen research ethics committees and regulatory agencies — especially those below WHO Maturity Level 3 — with mentoring and peer support from ML3/ML4 agencies. It also supports the development of digital regulatory platforms and pharmacovigilance systems integrated into national health systems. The aim is to build strong, lasting African institutional capacity for ethical and regulatory oversight of medical products, ensuring that new and existing health technologies can be evaluated safely, efficiently and to international standards.

Why this call matters The safe and ethical evaluation of medical products depends on strong research ethics committees, effective regulatory authorities and functioning pharmacovigilance systems. In many sub-Saharan African countries, these institutions are under-resourced and operate below the maturity levels needed to review clinical trials and market authorisations efficiently. Strengthening these institutions — through structured training, twinning with more mature agencies and digital innovation — is essential to enabling the region to conduct its own research, to participate fully in global product development, and to monitor the safety of medicines once they are in use. This call therefore contributes directly to health security and to public trust in the products on which African health systems depend.

Funding The total indicative budget for this call is EUR 15 million, intended to support up to 10 projects. The funding rate is 100% (lump sum).

Eligibility Consortia must comprise at least three independent legal entities from three different countries, with at least one from an EU Member State or associated country that is a member of the EDCTP Association, and at least one from a sub-Saharan African country member of the Association. This requirement is designed to ensure genuine collaboration between European and African partners and to maximise the transfer of expertise and resources to African institutions.

Expected outcomes - Improved digital infrastructure for clinical trial protocol review and marketing authorisation applications; - Accelerated use of digital technologies and data analytics for real-time safety monitoring and reporting; - Harmonisation of research ethics review across countries; - Stronger alignment with global ethics, regulatory and pharmacovigilance standards.

Who should apply The call is relevant to research ethics committees, regulatory agencies, public health institutes, pharmacovigilance centres, universities and other institutions involved in the ethics and regulatory oversight of medical products in sub-Saharan Africa and Europe. Organisations seeking to strengthen their systems through training, twinning or digital innovation, and mature agencies willing to provide mentoring and peer support, are all encouraged to consider forming a consortium and applying.

How to apply Proposals are submitted via the EU Funding & Tenders Portal. The full topic details, including the call reference HORIZON-JU-GH-EDCTP3-2026-03-SERP-01, are accessible through the application link on this listing. Ensure your consortium meets the minimum eligibility requirements before beginning your application, and allow sufficient time to complete the online submission process.

Deadline The deadline for submission is 2 September 2026 at 17:00 Brussels time.