{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T17:51:50Z","timestamp":1785433910509,"version":"3.56.0"},"reference-count":20,"publisher":"AOSIS","issue":"1","license":[{"start":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T00:00:00Z","timestamp":1781913600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:p>This article examines the strategic landscape facing the inaugural leadership of the African Medicines Agency. It outlines the core challenges constraining Africa\u2019s pharmaceutical sector: fragmented regulatory frameworks, inadequate clinical trial regulation, limited capacity for drug development (notably for neglected and emerging diseases) and slow access to novel medicines. Drawing upon the history of regulatory harmonisation in Africa, international best practices, and current continental initiatives, the article proposes a comprehensive agenda for leadership and operational priorities designed to strengthen regulatory performance, support domestic manufacturing, ensure ethical and efficient trial oversight, and broaden access to innovation. The conclusion calls for multisectoral collaboration, innovative financing and sustained political commitment to realise the vision of Agenda 2063 and universal access to quality medical products in Africa.<\/jats:p>","DOI":"10.4102\/jphia.v17i1.1712","type":"journal-article","created":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T13:25:59Z","timestamp":1781875559000},"update-policy":"https:\/\/doi.org\/10.4102\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Charting a new course: Recommendations for strategic priorities for the African Medicines Agency"],"prefix":"10.4102","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9186-8160","authenticated-orcid":false,"given":"Olawale","family":"Salami","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04c8tz716","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Global Health Equity"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3570-3254","authenticated-orcid":false,"given":"Emmanuel","family":"Agogo","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/05tcsqz68","id-type":"ROR","asserted-by":"publisher"}],"name":"FIND"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2580","published-online":{"date-parts":[[2026,6,20]]},"reference":[{"key":"ref0","doi-asserted-by":"crossref","unstructured":"GBD 2021 Risk Factors Collaborators. Global burden and strength of evidence for 88 risk factors in 204 countries and 811 subnational locations, 1990\u20132021: A systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024;403(10440):2162\u20132203. https:\/\/doi.org\/10.1016\/S0140-6736(24)00933-4","DOI":"10.1016\/S0140-6736(24)00933-4"},{"key":"ref1","doi-asserted-by":"crossref","unstructured":"Taylor-Robinson SD, Spearman CW, Suliman AAA. Why is there a paucity of clinical trials in Africa? QJM. 2021;114(6):357\u2013358. https:\/\/doi.org\/10.1093\/qjmed\/hcab010","DOI":"10.1093\/qjmed\/hcab010"},{"key":"ref2","doi-asserted-by":"crossref","unstructured":"Saied AA, Metwally AA, Dhawan M, Choudhary OP, Aiash H. Strengthening vaccines and medicines manufacturing capabilities in Africa: Challenges and perspectives. EMBO Mol Med. 2022;14(8):e16287. https:\/\/doi.org\/10.15252\/emmm.202216287","DOI":"10.15252\/emmm.202216287"},{"key":"ref3","doi-asserted-by":"crossref","unstructured":"Ngum N, Chamdimba C, Mbonyingingo D, et al. Suggested improvements to the current East African community medicines regulatory harmonization joint review process and a proposed new review model for this initiative. Pharmaceut Med 2025;39(2):125\u2013141. https:\/\/doi.org\/10.1007\/s40290-025-00554-1","DOI":"10.1007\/s40290-025-00554-1"},{"key":"ref4","doi-asserted-by":"crossref","unstructured":"Ngum N, Ndomondo-Sigonda M, Walker S, Salek S. Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency. Regul Toxicol Pharmacol. 2023;145:105497. https:\/\/doi.org\/10.1016\/j.yrtph.2023.105497","DOI":"10.1016\/j.yrtph.2023.105497"},{"key":"ref5","doi-asserted-by":"crossref","unstructured":"Zarocostas J. Health ministers adopt African Medicines Agency treaty. Lancet. 2018;391(10137):2310. https:\/\/doi.org\/10.1016\/s0140-6736(18)31313-8","DOI":"10.1016\/S0140-6736(18)31313-8"},{"key":"ref6","unstructured":"African Union. Dr. Delese Mimi Darko appointed Inaugural Director General of the African Medicines Agency (AMA) [homepage on the Internet]. African Union; 2025 [cited 2025 Jul 01]. Available from: https:\/\/au.int\/sw\/node\/44889"},{"key":"ref7","doi-asserted-by":"crossref","unstructured":"Nachega JB, Sam-Agudu NA, Masekela R, et al. Addressing challenges to rolling out COVID-19 vaccines in African countries. Lancet Glob Health. 2021;9(6):e746\u2013e748. https:\/\/doi.org\/10.1016\/s2214-109x(21)00097-8","DOI":"10.1016\/S2214-109X(21)00097-8"},{"key":"ref8","unstructured":"WHO awards top-level recognition to regulatory authorities in Canada, UK and Japan \u2013 Health policy watch [homepage on the Internet]. [cited 2025 Sep 28]. Available from: https:\/\/healthpolicy-watch.news\/who-awards-top-level-status-to-regulatory-authorities-in-canada-uk-and-japan\/"},{"key":"ref9","doi-asserted-by":"crossref","unstructured":"Hwenda L, Sidibe M, Makanga M. The African Medicines Agency: The key to unlocking clinical research in Africa. Lancet Glob Health. 2022;10(8):e1088\u2013e1089. https:\/\/doi.org\/10.1016\/S2214-109X(22)00243-1","DOI":"10.1016\/S2214-109X(22)00243-1"},{"key":"ref10","doi-asserted-by":"crossref","unstructured":"Osei CK, Nketiah-Amponsah E, Fenny AP, Otchere F. Vaccine pricing and production capacity in Africa: Can Africa move beyond pooled procurement in the face of a future pandemic? Glob Health J. 2024;8(4):172\u2013180. https:\/\/doi.org\/10.1016\/j.glohj.2024.11.001","DOI":"10.1016\/j.glohj.2024.11.001"},{"key":"ref11","unstructured":"Ncube BM. The implementation of the African union model law on medical products regulation and the establishment of the African medicines agency. Cape Town: University of Western Cape; 2022."},{"key":"ref12","unstructured":"Health Policy Watch. African Medicines Agency Countdown [homepage on the Internet]. Health Policy Watch; 2025 [cited 2026 Jan 19]. Available from: https:\/\/healthpolicy-watch.news\/african-medicines-agency-countdown\/"},{"key":"ref13","doi-asserted-by":"crossref","unstructured":"Ndomondo-Sigonda M, Ambali A. The African Medicines Regulatory harmonization initiative: Rationale and benefits. Clin Pharmacol Ther. 2011;89(2):176\u2013178. http:\/\/doi.org\/10.1038\/clpt.2010.299","DOI":"10.1038\/clpt.2010.299"},{"key":"ref14","doi-asserted-by":"crossref","unstructured":"Ncube BM, Dube A, Ward K. The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges. Front Med (Lausanne) 2023;10:1117439. https:\/\/doi.org\/10.3389\/fmed.2023.1117439","DOI":"10.3389\/fmed.2023.1117439"},{"key":"ref15","doi-asserted-by":"crossref","unstructured":"Hwenda L, Sidibe M, Makanga M. The African Medicines Agency: The key to unlocking clinical research in Africa. Lancet Glob Health. 2022;10(8):e1088\u2013e1089. https:\/\/doi.org\/10.1016\/S2214-109X(22)00243-1","DOI":"10.1016\/S2214-109X(22)00243-1"},{"key":"ref16","doi-asserted-by":"crossref","unstructured":"Egharevba E, Atkinson J. The role of corruption and unethical behaviour in precluding the placement of industry sponsored clinical trials in sub-Saharan Africa: Stakeholder views. Contemp Clin Trials Commun. 2016;3:102\u2013110. https:\/\/doi.org\/10.1016\/j.conctc.2016.04.009","DOI":"10.1016\/j.conctc.2016.04.009"},{"key":"ref17","doi-asserted-by":"crossref","unstructured":"Abdel-Maged AE, Mikhaeil MF, Elkordy AI, Gad AM, Elshazly MM. Biosimilars production in Africa opportunities & challenges. Regul Toxicol Pharmacol. 2024;149:105626. https:\/\/doi.org\/10.1016\/j.yrtph.2024.105626","DOI":"10.1016\/j.yrtph.2024.105626"},{"key":"ref18","unstructured":"Union, A. Opening Statement H.E. Amb. Amma Twum-Amoah, AUC Commissioner for HHS at Financial, Legal, Technical, Digital Systems and Operational Transfer of AMRH and AU3s from AUDA-NEPAD to AMA | African Union [homepage on the Internet]. 2026 [cited 2026 Feb 15]. Available from: https:\/\/au.int\/ar\/speeches\/20260123\/opening-statement-auc-commissioner-hhs-joint-formal-ama-handover-session"},{"key":"ref19","unstructured":"NEPAD, A. AfriVigilance | AUDA-NEPAD [homepage on the Internet]. 2021 [cited 2026 Feb 15]. Available from: https:\/\/www.nepad.org\/microsite\/afrivigilance"}],"container-title":["Journal of Public Health in Africa"],"original-title":[],"link":[{"URL":"https:\/\/publichealthinafrica.org\/index.php\/jphia\/article\/view\/1712\/3079","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,19]],"date-time":"2026-06-19T13:26:09Z","timestamp":1781875569000},"score":1,"resource":{"primary":{"URL":"https:\/\/publichealthinafrica.org\/index.php\/jphia\/article\/view\/1712"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,20]]},"references-count":20,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1,1]]}},"URL":"https:\/\/doi.org\/10.4102\/jphia.v17i1.1712","relation":{},"ISSN":["2038-9922","2038-9930"],"issn-type":[{"value":"2038-9922","type":"print"},{"value":"2038-9930","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,20]]},"article-number":"a1712"}}