CLINICAL DRUG DEVELOPMENT IN AFRICA: MAPPING THE JOURNEY FROM DRUG DISCOVERY TO REGULATORY APPROVAL AND CLINICAL IMPLEMENTATION - A SYSTEMATIC REVIEW
Abstract
Background: A widening gap exists between Africa's share of the global disease burden and its participation in clinical pharmaceutical research. The continent shoulders approximately one quarter of all disease globally yet contributed fewer than two percent of clinical trials conducted worldwide in 2023. This review systematically examines each phase of pharmaceutical development in Africa, tracing the pathway from compound discovery and preclinical work through regulated human trials, national approval processes, and implementation in clinical settings, with the goal of identifying where progress has been made and where critical deficiencies persist. Methods: Four electronic databases were searched - PubMed/MEDLINE, Scopus, Web of Science, and African Journals Online - covering publications from January 2015 to July 2025. Additional material was obtained from grey literature sources including official WHO documents, the Pan African Clinical Trials Registry, the African Union Commission, AUDA-NEPAD, SAHPRA, and the H3D Centre. Studies were eligible if they provided primary data or evidence synthesis on any phase of drug development, regulatory approval, or clinical implementation in Africa. All methods followed PRISMA 2020 reporting standards. Results: The African pharmaceutical research landscape is dominated by three countries - South Africa, Egypt, and Nigeria - which collectively account for approximately 70% of all trials conducted on the continent. South Africa alone recorded over 4,000 trial initiations. Globally, Africa hosted just 845 of 76,331 newly initiated trials in 2023. The H3D Centre at the University of Cape Town achieved a historic milestone by advancing Africa's first internally developed antimalarial compound into Phase II human testing. The Pan African Clinical Trials Registry accumulated 2,998 registered studies by August 2021. Conclusion: Africa holds substantial and largely unrealised potential as a driver of pharmaceutical innovation. Translating this potential requires coordinated investment in scientific training, laboratory infrastructure, regulatory capacity, and post-approval surveillance. Peer Review History: Received 2 June 2026; Reviewed 7 July 2026; Accepted 4 August; Available online 15 September 2026 Academic Editor: Prof. Dr. Gorkem Dulger, Duzce University, Turkey, gorkemdulger@yandex.com Reviewers: Dr. Taiwo O Elufioye, University of Ibadan, Nigeria, toonitaiwo@yahoo.com Dr. Tamer Elhabibi, Suez Canal University, Egypt, tamer_hassan@pharm.suez.edu.eg