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However, in many low\u2010 and middle\u2010income countries, especially across Africa, the current quality assurance paradigm\u2014largely driven by historical donor preferences for WHO prequalification and stringent regulatory authority approval\u2014can unintentionally limit access, equity, and sustainability. While these requirements have been effective in ensuring client safety, they can result in higher expenditures, reduced coverage, and deepening inequities. Moreover, such narrow focus risks undermining the authority of national regulatory authorities (NRAs), diminished economic development opportunities, erosion of trust in local health systems, and vulnerabilities to external shocks. This paper argues for a more inclusive approach to defining quality standards for procurement eligibility. It proposes qualifying for procurement products with marketing authorizations granted by NRAs that have achieved at least Maturity Level 3\u2014a designation based on the WHO Global Benchmarking Tool that indicates a stable, well\u2010functioning, integrated regulatory system; establishing financing mechanisms to minimize the budget impact of more costly quality medicines; promoting regulatory reliance through regional harmonization; and investing in system\u2010wide regulatory strengthening. Such a model would not only enhance access to safe and effective medicines but also foster local regulatory capacity, support domestic pharmaceutical industries, reduce overdependence on donors and imported products, and promote self\u2010reliance. By rethinking quality assurance strategies and aligning them with regional progress and aspirations, Africa can build more resilient, autonomous health systems and advance toward sustainable health equity.<\/jats:p>","DOI":"10.1002\/ijgo.71047","type":"journal-article","created":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T03:10:02Z","timestamp":1780974602000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Moving beyond a legacy paradigm: A vision for equitable access to quality medicines in Africa"],"prefix":"10.1002","volume":"172","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7277-4967","authenticated-orcid":false,"given":"Naoko","family":"Doi","sequence":"first","affiliation":[{"name":"Jhpiego  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bright C.","family":"Orji","sequence":"additional","affiliation":[{"name":"Jhpiego  Abuja Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Ruffo","sequence":"additional","affiliation":[{"name":"PATH  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Mukumbayi","sequence":"additional","affiliation":[{"name":"PATH  Kinshasa Democratic Republic of Congo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Kibonge","sequence":"additional","affiliation":[{"name":"PATH  Nairobi Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael Mwiti","family":"Muthamia","sequence":"additional","affiliation":[{"name":"Jhpiego  Nairobi Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Tappis","sequence":"additional","affiliation":[{"name":"Jhpiego  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franck","family":"Biayi","sequence":"additional","affiliation":[{"name":"Minist\u00e8re de la Sant\u00e9 Publique Programme National d'Approvisionnement en M\u00e9dicaments  Kinshasa Democratic Republic of Congo"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Talatu Y.","family":"Kassim","sequence":"additional","affiliation":[{"name":"Federal Ministry of Health Food and Drugs  Abuja Nigeria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert","family":"Ndwiga","sequence":"additional","affiliation":[{"name":"Ministry of Health Division of RMNCAH  Nairobi Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,8]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products","author":"World Health Organization","year":"2017"},{"key":"e_1_2_10_3_1","volume-title":"A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products","author":"World Health Organization","year":"2017"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0236060"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.14197"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0258096"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-068442"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-017-0210-x"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40290-022-00425-z"},{"key":"e_1_2_10_10_1","unstructured":"The Global Fund.Quality Assurance Policy for Pharmaceutical Products.2023Accessed March 12 2026.https:\/\/www.theglobalfund.org\/media\/0jmj2qqn\/psm_qa\u2010pharmaceutical\u2010products_policy_en.pdf"},{"key":"e_1_2_10_11_1","unstructured":"United Nations Population Fund.UNFPA Quality Assurance Framework for the Procurement of Reproductive Health Commodities. 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