{
  "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.\n\nMethods: 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.\n\nResults: 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.\n\nConclusions: 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.",
  "abstract_shown": true,
  "affiliations": [
    "Roche Products Pty Ltd Johannesburg South Africa",
    "Fundisa African Academy of Medicines Development Cape Town South Africa",
    "Vicore Health Moka Mauritius",
    "Gilead Sciences Pty Ltd Johannesburg South Africa",
    "Department of Pathology Stellenbosch University Cape Town South Africa",
    "Synexa Life Sciences Cape Town South Africa",
    "Tiervlei Trial Centre Cape Town South Africa",
    "Pharmacometrics Africa NPC Cape Town South Africa",
    "Division of Clinical Pharmacology University of Cape Town Cape Town South Africa",
    "Department of Pharmacology and Therapeutics University of Liverpool Liverpool UK",
    "Infectious Diseases Institute Makerere University College of Health Sciences Kampala Uganda",
    "Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences Stellenbosch University Cape Town South Africa",
    "Institute for Clinical Pharmacology and Toxicology Charité Universitätsmedizin Berlin Berlin Germany"
  ],
  "article_type": "review article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Tirhani Maluleke",
      "orcid": "0000-0002-0266-2281"
    },
    {
      "affs": [
        1,
        2
      ],
      "name": "Emile Malan"
    },
    {
      "affs": [
        3
      ],
      "name": "Michael Reid"
    },
    {
      "affs": [
        1,
        4,
        5
      ],
      "name": "Patrick Bouic"
    },
    {
      "affs": [
        1,
        6
      ],
      "name": "Haylene Nell"
    },
    {
      "affs": [
        1,
        7,
        8
      ],
      "name": "Goonaseelan Pillai",
      "orcid": "0000-0002-5658-3837"
    },
    {
      "affs": [
        9,
        10
      ],
      "name": "Catriona Waitt",
      "orcid": "0000-0003-0134-5855"
    },
    {
      "affs": [
        1,
        11,
        12
      ],
      "name": "Bernd Rosenkranz"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/7dkhz6w6ct2g1.bib",
  "cited_by": 0,
  "doi": "10.1002/bcp.70770",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13714611/",
  "id": "7dkhz6w6ct2g1",
  "issns": [
    "0306-5251",
    "1365-2125"
  ],
  "landing_url": "https://doi.org/10.1002/bcp.70770",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Review Article"
    ],
    [
      "openalex",
      "2739|Biotechnology and Related Fields"
    ]
  ],
  "openalex": "W7202302648",
  "pdf_url": null,
  "pmcid": "PMC13714611",
  "pmid": "42584193",
  "published": "2026-08-12",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/7dkhz6w6ct2g1.ris",
  "sources": [
    {
      "first_seen": "2026-11-01T12:22:04Z",
      "native_id": "PMC13714611",
      "source": "pmc",
      "url": "https://doi.org/10.1002/bcp.70770"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2739|Biotechnology and Related Fields",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Capacity building in medicines development and regulation in Africa—Overview on recent progress",
  "title_text": "Capacity building in medicines development and regulation in Africa—Overview on recent progress",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:22:04Z",
  "url": "https://research.draconitic.com/paper/7dkhz6w6ct2g1",
  "venue": "British Journal of Clinical Pharmacology",
  "versions": []
}