Capacity building in medicines development and regulation in Africa-Overview on recent progress.

Authors

Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz

Published in

British journal of clinical pharmacology. Aug 12, 2026. Epub Aug 12, 2026.

Abstract

Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity-building efforts and a shortage of skilled professionals in medicines development and regulatory science. This review explores existing gaps and assesses collaborative approaches to enhancing capacity in this field. It further marks 10 years of sustained contribution by the Fundisa African Academy of Medicines Development towards its advancement.
A narrative review was conducted to assess capacity-building initiatives in medicines development and regulation across Africa. Particular focus was placed on the contributions of the Fundisa African Academy of Medicines Development, in collaboration with partners including academia, clinical research sites, industry and regulatory authorities.
Capacity-building efforts across the continent remain heterogeneous and are often implemented in a fragmented manner. Collaborative initiatives, such as those led by the Fundisa African Academy of Medicines Development and its partners, illustrate the potential to mitigate these gaps through accredited training, targeted skills development and experiential learning programmes. Such initiatives support the strengthening of competencies along the entire medicines development continuum, spanning drug discovery, clinical research and regulatory and health economic evaluation.
Sustainable capacity strengthening in Africa requires coordinated, context-specific approaches that address the full health research value chain, from investigators to regulatory assessors. Integration of digital health platforms as force multipliers, adoption of standardized competency frameworks such as the WHO Global Competency Framework and development of centralized systems to monitor capacity-building activities are essential to reduce fragmentation and promote regional collaboration.

PMID:
42584193
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.

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