{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T21:18:13Z","timestamp":1792703893383,"version":"4.5.0"},"reference-count":30,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T00:00:00Z","timestamp":1770163200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The African continent has long faced fragmented regulatory systems, resulting in delayed access to safe, effective, and quality-assured medical products. To address these challenges, the African Medicines Regulatory Harmonisation (AMRH) Programme was launched in 2009 by the African Union, laying the groundwork for the establishment of the African Medicines Agency (AMA). The AMA represents one of the most significant continental developments to harmonize regulatory practices, improve access to quality-assured medical products, and strengthen public health systems across Africa.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The objectives of this review were to examine the historical development of AMA, its Treaty and proposed institutional framework, as well as operational pilots such as the Continental Listing of Human Medicinal Products implemented by the AMRH since 2023.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A narrative literature review approach was used, sourcing official African Union documents, peer-reviewed publications, and technical reports from African Union Commission, AUDA-NEPAD, WHO, and AMRH stakeholders published between 2005 and 2025.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The AMA was formally established by treaty adopted by the AU heads of states and governments in 2019 and entered into force in November 2021. As of June 2025, 31\u202fAU Member States had ratified the Treaty. The agency\u2019s governance and organizational structure include a Conference of State Parties, Governing Board, Secretariat, and Technical Committees. Pilot projects such as the AMRH Continental Listing demonstrated the feasibility of reliance mechanisms, though challenges remain in national legal harmonization, funding, and capacity disparities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The AMA represents a transformative step toward regulatory convergence in Africa. While challenges persist, the Treaty framework and pilot outcomes provide a strong foundation for its operationalisation and the long-term success in improving medical product regulation and public health across the continent.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1763261","type":"journal-article","created":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T05:34:06Z","timestamp":1770183246000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":10,"title":["The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects"],"prefix":"10.3389","volume":"13","author":[{"given":"Alex Juma","family":"Ismail","sequence":"first","affiliation":[{"name":"School of Health, Medicine and Life Sciences, University of Hertfordshire","place":["Hatfield, United Kingdom"]},{"name":"African Medicines Regulatory Harmonisation Initiative, AUDA-NEPAD","place":["Johannesburg, South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delese Mimi","family":"Darko","sequence":"additional","affiliation":[{"name":"African Medicines Agency","place":["Kigali, Rwanda"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stuart","family":"Walker","sequence":"additional","affiliation":[{"name":"School of Health, Medicine and Life Sciences, University of Hertfordshire","place":["Hatfield, United Kingdom"]},{"name":"Centre for Innovation in Regulatory Science","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sam","family":"Salek","sequence":"additional","affiliation":[{"name":"School of Health, Medicine and Life Sciences, University of Hertfordshire","place":["Hatfield, United Kingdom"]},{"name":"Institute for Medicines Development","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,2,4]]},"reference":[{"key":"ref1","volume-title":"African medicines agency ratification status","year":"2025"},{"key":"ref2","volume-title":"WHO global benchmarking tool (GBT) for evaluation of National Regulatory Systems of medical products \u2013 Revision VI","year":"2021"},{"key":"ref3","volume-title":"Treaty for the establishment of the African medicines agency","year":"2019"},{"key":"ref4","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1080\/02763869.2017.1259891","article-title":"Managing and coding references for systematic reviews and scoping reviews in EndNote","volume":"36","author":"Brigham","year":"2017","journal-title":"Med Ref Serv Q"},{"key":"ref5","volume-title":"Executive council decision EX.CL\/Dec.857(XXVI) on the establishment of the African medicines agency (AMA)","year":"2015"},{"key":"ref6","first-page":"105447","article-title":"Establishing the African medicines agency: opportunities and challenges for strengthening regulatory capacity in Africa","volume":"140","author":"Tumusiime","year":"2023","journal-title":"Regul Toxicol Pharmacol"},{"key":"ref7","volume-title":"Support for the African medicines agency","year":"2022"},{"key":"ref8","volume-title":"2025 AMA organizational plan","year":"2025"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"105497","DOI":"10.1016\/j.yrtph.2023.105497","article-title":"Regional medicines regulatory harmonisation initiatives: their potential to contribute to the AMA\u2019S effectiveness and efficiency","volume":"143","author":"Ngum","year":"2023","journal-title":"Regul Toxicol Pharmacol"},{"key":"ref10","doi-asserted-by":"crossref","first-page":"1437970","DOI":"10.3389\/fmed.2024.1437970","article-title":"Evaluation of good review practices in member authorities of the east African community MRH initiative: strategies for alignment with African medicines agency","volume":"11","author":"Ngum","year":"2024","journal-title":"Front Med"},{"key":"ref11","volume-title":"Best practices for strengthening African regulatory systems","year":"2023"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"1117439","DOI":"10.3389\/fmed.2023.1117439","article-title":"The domestication of the African union model law on medical products regulation: perceived benefits, enabling factors, and challenges","volume":"10","author":"Ncube","year":"2023","journal-title":"Front Med"},{"key":"ref13","volume-title":"African medicines agency (African union)","year":"2025"},{"key":"ref14","volume-title":"Senegal and Rwanda achieve WHO maturity level 3 in medicines regulation","year":"2024"},{"key":"ref15","first-page":"29","article-title":"Effect of joint inspections on GMP compliance among pharmaceutical manufacturers in ECOWAS","volume":"15","author":"Abdullahi","year":"2022","journal-title":"J 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regulation for the EMA centralised procedure","year":"2022"},{"key":"ref23","first-page":"1","article-title":"Regulation (EC) no 726\/2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European medicines agency","year":"2004","journal-title":"Off J Eur Union"},{"key":"ref24","first-page":"117","article-title":"Economic and health impact of a continental regulatory agency: modelling the benefits of the African medicines agency","volume":"14","author":"Mwendera","year":"2022","journal-title":"Glob Health Econ Policy"},{"key":"ref25","article-title":"Ratifying the African medicines agency treaty","year":"2024"},{"key":"ref26","volume-title":"How VigiFlow is helping to keep the wheel of pharmacovigilance turning in South Africa. 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