Capacity building in medicines development and regulation in Africa—Overview on recent progress
13 affiliations
- 1Roche Products Pty Ltd Johannesburg South Africa
- 2Fundisa African Academy of Medicines Development Cape Town South Africa
- 3Vicore Health Moka Mauritius
- 4Gilead Sciences Pty Ltd Johannesburg South Africa
- 5Department of Pathology Stellenbosch University Cape Town South Africa
- 6Synexa Life Sciences Cape Town South Africa
- 7Tiervlei Trial Centre Cape Town South Africa
- 8Pharmacometrics Africa NPC Cape Town South Africa
- 9Division of Clinical Pharmacology University of Cape Town Cape Town South Africa
- 10Department of Pharmacology and Therapeutics University of Liverpool Liverpool UK
- 11Infectious Diseases Institute Makerere University College of Health Sciences Kampala Uganda
- 12Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South Africa
- 13Institute for Clinical Pharmacology and Toxicology Charité Universitätsmedizin Berlin Berlin Germany
Abstract
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 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.
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 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.
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BibTeX
@article{maluleke2026capacity,
title = {{Capacity building in medicines development and regulation in Africa—Overview on recent progress}},
author = {Tirhani Maluleke and Emile Malan and Michael Reid and Patrick Bouic and Haylene Nell and Goonaseelan Pillai and Catriona Waitt and Bernd Rosenkranz},
journal = {British Journal of Clinical Pharmacology},
year = {2026},
month = aug,
doi = {10.1002/bcp.70770},
url = {https://doi.org/10.1002/bcp.70770},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Capacity building in medicines development and regulation in Africa—Overview on recent progress
AU - Tirhani Maluleke
AU - Emile Malan
AU - Michael Reid
AU - Patrick Bouic
AU - Haylene Nell
AU - Goonaseelan Pillai
AU - Catriona Waitt
AU - Bernd Rosenkranz
PY - 2026
DA - 2026/08/12
JO - British Journal of Clinical Pharmacology
DO - 10.1002/bcp.70770
UR - https://doi.org/10.1002/bcp.70770
AB - 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 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. 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 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.
SN - 0306-5251
SN - 1365-2125
ER -