Aims 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 aims to examine current gaps and evaluate collaborative approaches to strengthening capacity in this field. Methods 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. Results 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. Conclusions 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 standardised competency frameworks such as the WHO Global Competency Framework, and development of centralised systems to monitor capacity-building activities are essential to reduce fragmentation and promote regional collaboration.
