{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T05:04:59Z","timestamp":1790744699190,"version":"4.1.0"},"reference-count":30,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T00:00:00Z","timestamp":1776902400000},"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>Limited capacity in African national medicine regulatory authorities results in delayed registrations, regulatory inefficiencies, and the ongoing circulation of substandard and falsified medicines. The African Medicines Regulatory Harmonization initiative and regional mechanisms work to make medicine approval faster and fairer across Africa using convergent mechanisms. We aim to map and integrate evidence on pharmaceutical regulatory harmonization in Africa, concentrating on policy, implementation strategies, and reported outcomes, and identify barriers, facilitators, and evidence gaps to guide future research and policy formulation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This scoping review applied Arksey and O\u2019Malley\u2019s framework (Levac refinements) and PRISMA-ScR reporting standards. Systematic searches of PubMed, Scopus, Web of Science, Embase, and targeted gray literature identified English-language sources addressing policy design, implementation, governance, barriers\/facilitators, and outcomes of pharmaceutical regulatory harmonization in Africa. Data from 19 included documents (2015\u20132025) were charted and synthesized via descriptive summaries and inductive thematic analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The primary strategies included joint reviews, collaboration in Good Manufacturing Practice (GMP) inspections, regulatory reliance, standardized technical guidelines, and partnership-based capacity building. Documented improvements encompassed significant reductions in median joint review durations (e.g., EAC: 553\u2013259 days), elevated application volumes, enhanced adherent GMP rates, improved Global Benchmarking Tool maturity levels, and economically viable regional recommendations. Major barriers were resource limitations, maturity differentials, delayed national uptake, weak binding reliance, coordination inefficiencies, and donor dependency; key facilitators included political will, partner support, International Medicines Regulatory Authority (IMRA) trust, and proven process efficiencies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Regional harmonization has produced significant regulatory efficiency and capability in East and Southern Africa. Regional harmonization has resulted in continued progress toward the Africa Medicine Agency necessities, enhanced political dedication, and diversified funding. Expedited adoption of standardized protocols, reinforced reliance mechanisms, and theory-based longitudinal assessments are needed to ensure equitable and sustainable access to quality pharmaceuticals.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1812798","type":"journal-article","created":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T05:37:10Z","timestamp":1776922630000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Pharmaceutical regulatory harmonization in Africa: a scoping review of policy design, implementation approaches, and outcomes"],"prefix":"10.3389","volume":"13","author":[{"given":"Julius","family":"Niyibizi","sequence":"first","affiliation":[{"name":"Pharmacist","place":["Kigali, Rwanda"]},{"name":"Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Mugisha","sequence":"additional","affiliation":[{"name":"Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Songa","sequence":"additional","affiliation":[{"name":"Rwanda Food and Drugs Authority","place":["Kigali, Rwanda"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Nizeyimana","sequence":"additional","affiliation":[{"name":"Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane Badaga","family":"Isimbi","sequence":"additional","affiliation":[{"name":"Southern Medical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,4,23]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"83","DOI":"10.1007\/s40290-022-00425-z","article-title":"Medicines regulatory science expertise in africa: workforce capacity development and harmonisation activities towards the establishment of the african medicines agency.","volume":"36","author":"Ncube","year":"2022","journal-title":"Pharmaceut Med."},{"key":"B2","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1186\/s12889-021-10169-1","article-title":"Harmonization of medical products regulation: a key factor for improving regulatory capacity in the East African Community.","volume":"21","author":"Ndomondo-Sigonda","year":"2021","journal-title":"BMC Public Health."},{"key":"B3","doi-asserted-by":"publisher","first-page":"109","DOI":"10.3233\/PPL-160437","article-title":"Accelerating regulatory approvals through the world health organization collaborative registration procedures.","volume":"18","author":"Go\u00f1i","year":"2016","journal-title":"Pharmaceut Policy Law."},{"key":"B4","doi-asserted-by":"publisher","first-page":"99","DOI":"10.3233\/PPL-160436","article-title":"Accelerating patient access to medicines in the economic community of West African States, the Southern African Development Community and the Organization for the Coordination of the Fight Against Endemic Diseases.","volume":"18","author":"Lahlou","year":"2016","journal-title":"Pharmaceut Policy Law."},{"key":"B5","doi-asserted-by":"publisher","first-page":"91","DOI":"10.3233\/PPL-160435","article-title":"Towards African medicines regulatory harmonization: the case of the east african community.","volume":"18","author":"Mwangi","year":"2016","journal-title":"Pharmaceut Policy Law."},{"key":"B6","doi-asserted-by":"publisher","first-page":"1069345","DOI":"10.3389\/fphar.2022.1069345","article-title":"Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries.","volume":"13","author":"Owusu-Asante","year":"2022","journal-title":"Front Pharmacol."},{"key":"B7","doi-asserted-by":"publisher","first-page":"8070","DOI":"10.34172\/ijhpm.2024.8070","article-title":"Comparison of three regional medicines regulatory harmonisation initiatives in africa: opportunities for improvement and alignment.","volume":"13","author":"Sithole","year":"2024","journal-title":"Int J Health Policy Manag."},{"key":"B8","doi-asserted-by":"publisher","first-page":"1207954","DOI":"10.3389\/fmed.2023.1207954","article-title":"What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements.","volume":"10","author":"Miletic","year":"2023","journal-title":"Front Med."},{"key":"B9","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1080\/1364557032000119616","article-title":"Scoping studies: towards a methodological framework.","volume":"8","author":"Arksey","year":"2005","journal-title":"Int J Soc Res Methodol."},{"key":"B10","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1186\/1748-5908-5-69","article-title":"Scoping studies: advancing the methodology.","volume":"5","author":"Levac","year":"2010","journal-title":"Implement Sci."},{"key":"B11","doi-asserted-by":"publisher","first-page":"467","DOI":"10.7326\/M18-0850","article-title":"PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation.","volume":"169","author":"Tricco","year":"2018","journal-title":"Ann Intern Med."},{"key":"B12","doi-asserted-by":"publisher","first-page":"104416","DOI":"10.1016\/j.drudis.2025.104416","article-title":"Transitioning to regulatory harmonisation for medicines: a comparison between Africa and Europe.","volume":"30","author":"Narsai","year":"2025","journal-title":"Drug Discov Today."},{"key":"B13","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1186\/s12913-024-10585-0","article-title":"Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation.","volume":"24","author":"Narsai","year":"2024","journal-title":"BMC Health Serv Res."},{"key":"B14","doi-asserted-by":"publisher","first-page":"1020","DOI":"10.1186\/s12913-024-11452-8","article-title":"Quality improvement in medicines regulation: a retrospective analysis of the Pharmacy Board of Sierra Leone before and during quality management system implementation.","volume":"24","author":"Lahai","year":"2024","journal-title":"BMC Health Serv Res."},{"key":"B15","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1186\/s40545-020-00281-9","article-title":"Establishment of the African Medicines Agency: progress, challenges and regulatory readiness.","volume":"14","author":"Ncube","year":"2021","journal-title":"J Pharm Policy Pract."},{"key":"B16","doi-asserted-by":"publisher","first-page":"447","DOI":"10.1093\/heapol\/czae017","article-title":"The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies.","volume":"39","author":"Ncube","year":"2024","journal-title":"Health Policy Plan."},{"key":"B17","doi-asserted-by":"publisher","first-page":"259","DOI":"10.4314\/ejhs.v26i3.9","article-title":"Pharmaceutical Regulatory Framework in Ethiopia: a Critical Evaluation of Its Legal Basis and Implementation.","volume":"26","author":"Suleman","year":"2016","journal-title":"Ethiop J Health Sci."},{"key":"B18","volume-title":"Cooperation Framework Agreement for EAC Partner States National Medicines Regulatory Authorities.","year":"2018"},{"key":"B19","volume-title":"Develop a Sustainable Financing Model for National Medicines Regulatory Agencies in the East African Community.","year":"2016"},{"key":"B20","volume-title":"EAC Joint Regulatory Procedures.","year":"2020"},{"key":"B21","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":"B22","doi-asserted-by":"publisher","first-page":"1362253","DOI":"10.3389\/fmed.2024.1362253","article-title":"Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.","volume":"11","author":"Alfonso","year":"2024","journal-title":"Front Med."},{"key":"B23","doi-asserted-by":"publisher","first-page":"1644446","DOI":"10.3389\/fmed.2025.1644446","article-title":"Performance analysis of EAC joint GMP inspections (2016-2022): a pathway to strengthening regulatory systems and building capacity in Africa\u2019s less resourced authorities.","volume":"12","author":"Mashingia","year":"2025","journal-title":"Front Med."},{"key":"B24","doi-asserted-by":"publisher","first-page":"2436898","DOI":"10.1080\/20523211.2024.2436898","article-title":"Understanding the regulatory-procurement interface for medicines in Africa via publicly available information on standards, implementation, and enforcement in five countries.","volume":"18","author":"Kohler","year":"2025","journal-title":"J Pharm Policy Pract."},{"key":"B25","doi-asserted-by":"publisher","first-page":"2490565","DOI":"10.1080\/20523211.2025.2490565","article-title":"Evaluation of the implementation and the associated operating costs of a medicine regulatory harmonisation model in Africa: the case of ZaZiBoNa, a SADC work-sharing initiative.","volume":"18","author":"Dube-Mwedzi","year":"2025","journal-title":"J Pharm Policy Pract."},{"key":"B26","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1007\/s40290-025-00554-1","article-title":"Suggested improvements to the current East African community medicines regulatory harmonization joint review process and a proposed new review model for this initiative.","volume":"39","author":"Ngum","year":"2025","journal-title":"Pharmaceut Med."},{"key":"B27","doi-asserted-by":"publisher","first-page":"e0003241","DOI":"10.1371\/journal.pgph.0003241","article-title":"Strengthening regulation for medical products in Tanzania: an assessment of regulatory capacity development, 1978-2020.","volume":"4","author":"Fimbo","year":"2024","journal-title":"PLoS Glob Public Health."},{"key":"B28","doi-asserted-by":"publisher","first-page":"331","DOI":"10.1177\/01410768231181263","article-title":"Registration of essential medicines in Kenya, Tanzania and Uganda: a retrospective analysis.","volume":"116","author":"Green","year":"2023","journal-title":"J R Soc Med."},{"key":"B29","doi-asserted-by":"publisher","first-page":"1437970","DOI":"10.3389\/fmed.2024.1437970","article-title":"Evaluation of good review practices in member authorities of the East African Medicines Regulatory Harmonisation initiative: strategies for alignment with African medicines agency.","volume":"11","author":"Ngum","year":"2024","journal-title":"Front Med."},{"key":"B30","doi-asserted-by":"publisher","first-page":"1763261","DOI":"10.3389\/fmed.2026.1763261","article-title":"The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects.","volume":"13","author":"Ismail","year":"2026","journal-title":"Front Med."}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1812798\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T05:37:11Z","timestamp":1776922631000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1812798\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,23]]},"references-count":30,"alternative-id":["10.3389\/fmed.2026.1812798"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1812798","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,23]]},"article-number":"1812798"}}