{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T06:25:25Z","timestamp":1787034325935,"version":"build-2736575974"},"reference-count":34,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity\u2010building 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\u2009years of sustained contribution by the Fundisa African Academy of Medicines Development towards its advancement.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A narrative review was conducted to assess capacity\u2010building 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Capacity\u2010building 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Sustainable capacity strengthening in Africa requires coordinated, context\u2010specific 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\u2010building activities are essential to reduce fragmentation and promote regional collaboration.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70770","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T13:39:14Z","timestamp":1786541954000},"source":"Crossref","is-referenced-by-count":0,"title":["Capacity building in medicines development and regulation in Africa\n                    <b>\u2014<\/b>\n                    Overview on recent progress"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0266-2281","authenticated-orcid":false,"given":"Tirhani","family":"Maluleke","sequence":"first","affiliation":[{"name":"Roche Products Pty Ltd  Johannesburg South Africa"},{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emile","family":"Malan","sequence":"additional","affiliation":[{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"},{"name":"Vicore Health  Moka Mauritius"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Reid","sequence":"additional","affiliation":[{"name":"Gilead Sciences Pty Ltd  Johannesburg South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Bouic","sequence":"additional","affiliation":[{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"},{"name":"Department of Pathology Stellenbosch University  Cape Town South Africa"},{"name":"Synexa Life Sciences  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haylene","family":"Nell","sequence":"additional","affiliation":[{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"},{"name":"Tiervlei Trial Centre  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5658-3837","authenticated-orcid":false,"given":"Goonaseelan","family":"Pillai","sequence":"additional","affiliation":[{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"},{"name":"Pharmacometrics Africa NPC  Cape Town South Africa"},{"name":"Division of Clinical Pharmacology University of Cape Town  Cape Town South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0134-5855","authenticated-orcid":false,"given":"Catriona","family":"Waitt","sequence":"additional","affiliation":[{"name":"Department of Pharmacology and Therapeutics University of Liverpool  Liverpool UK"},{"name":"Infectious Diseases Institute Makerere University College of Health Sciences  Kampala Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Rosenkranz","sequence":"additional","affiliation":[{"name":"Fundisa African Academy of Medicines Development  Cape Town South Africa"},{"name":"Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences Stellenbosch University  Cape Town South Africa"},{"name":"Institute for Clinical Pharmacology and Toxicology Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"WHO.List of National Regulatory Authorities (NRAs) operating at Maturity Level 3 (ML3) and Maturity Level 4 (ML4) published 9 April 2026. Accessed December 12 2025.https:\/\/www.who.int\/publications\/m\/item\/list-of-nras-operating-at-ml3-and-ml4"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s43441\u2010025\u201000879\u20108"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2025.1587761"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1371\/journalpgph.0001651"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/bcp.70697"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/hcs2.117"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2026.1763261"},{"key":"e_1_2_10_9_1","unstructured":"European & Developing Countries Clinical Trials Partnership (EDCTP).The importance of capacity building and development of a clinical research infrastructure in Africa.2021. Africa\u2010Europe Science and Innovation Summit. Accessed March 3 2026.https:\/\/www.edctp.org\/news\/recommendations-from-the-edctp-ecrin-session-on-clinical-trial-infrastructure-and-capacity-building-in-africa"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2024.1418382"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2021-005190"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40545\u2010020\u201000255"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15020"},{"issue":"1","key":"e_1_2_10_14_1","first-page":"6","article-title":"Towards a global competency framework for regulators of medical products","volume":"33","author":"WHO","year":"2019","journal-title":"WHO Drug Inf"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yrtph.2025.105893"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.70351"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2025.1706139"},{"key":"e_1_2_10_18_1","unstructured":"CardonaMA Rodr\u00edguezRJ IshmaelK US Department of Education Office of Educational Technology Artificial intelligence and the future of teaching and learning. Insights and recommendations. Washington DC.2023. Accessed August 8 2026.https:\/\/www.ed.gov\/sites\/ed\/files\/documents\/ai-report\/ai-report.pdf"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.31478\/202206e"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2025.1544678"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2015.00080"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.18063\/JMDS.2015.02.006"},{"key":"e_1_2_10_23_1","unstructured":"United Nations.Capacity building. Accessed December 12 2025.https:\/\/www.un.org\/en\/academic-impact\/capacity-building"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s44155\u2010023\u201000051\u20103"},{"key":"e_1_2_10_25_1","unstructured":"WHO.Global competency framework for regulators of medicines.2023.https:\/\/www.who.int\/publications\/i\/item\/9789240078758"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12961\u2010011\u201000849\u20108"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2013.00112"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.16192"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.4126\/FRL01\u2010006483852"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.70249"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.13291"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10389\u2010025\u201002499\u2010w"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2018.01407"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2026.1812798"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.699063"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70770","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/bcp.70770","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70770","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:37:59Z","timestamp":1787031479000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70770"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,12]]},"references-count":34,"alternative-id":["10.1002\/bcp.70770"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70770","archive":["Portico"],"relation":{"has-preprint":[{"id-type":"doi","id":"10.22541\/au.177562653.32097532\/v1","asserted-by":"object"}]},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,12]]},"article-number":"bcp.70770"}}