Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness

dc.contributor.authorNcube, Bakani Mark
dc.contributor.authorDube, Admire
dc.contributor.authorWard, Kim
dc.date.accessioned2021-04-14T11:58:38Z
dc.date.available2021-04-14T11:58:38Z
dc.date.issued2021
dc.description.abstractInsufcient access to quality, safe, efcacious and afordable medical products in Africa has posed a signifcant challenge to public health for decades. In part, this is attributed to weak or absent policies and regulatory systems, a lack of competent regulatory professionals in National Medicines Regulatory Authorities (NMRAs) and inefective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation eforts were introduced through the African Medicines Regulatory Harmonisation (AMRH) initiative to, among others, expedite market authorisation of medical products and to facilitate the alignment of national legislative frameworks with the AU Model Law on Medical Products Regulation. The goals of the model law include to increase collaboration across countries and to facilitate the overall regional harmonisation process. The AMRH initiative is proposed to serve as the foundation for the establishment of the African Medicines Agency (AMA). The AMA will, as one of its mandates, coordinate the regional harmonisation systems that are enabled by AU Model Law domestication and implementation. In this paper, we review the key entities involved in regional and continental harmonisation of medicines regulation, the milestones achieved in establishing the AMA as well as the implementation targets and anticipated challenges related to the AU Model Law domestication and the AMA’s establishment. This review shows that implementation targets for the AU Model Law have not been fully met, and the AMA treaty has not been ratifed by the minimum required number of countries for its establishment. In spite of the challenges, the AU Model Law and the AMA hold promise to address gaps and inconsistencies in national regulatory legislation as well as to ensure efective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.en_US
dc.identifier.citationNcube, B. M. et a. (2021). Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness. Journal of Pharmaceutical Policy and Practice 14(1),29en_US
dc.identifier.issn20523211
dc.identifier.uri10.1186/s40545-020-00281-9
dc.identifier.urihttp://hdl.handle.net/10566/6019
dc.language.isoenen_US
dc.publisherSpringer Natureen_US
dc.subjectAfrican Medicines Agencyen_US
dc.subjectAfrican Medicines Regulatory Harmonisation Initiativeen_US
dc.subjectAU model law on medical products regulationen_US
dc.subjectPharmaceutical policyen_US
dc.subjectMedicines regulatory harmonisationen_US
dc.titleEstablishment of the African Medicines Agency: Progress, challenges and regulatory readinessen_US
dc.typeArticleen_US

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