Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness
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Date
2021
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Publisher
Springer Nature
Abstract
Insufcient 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.
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Keywords
African Medicines Agency, African Medicines Regulatory Harmonisation Initiative, AU model law on medical products regulation, Pharmaceutical policy, Medicines regulatory harmonisation
Citation
Ncube, B. M. et a. (2021). Establishment of the African Medicines Agency: Progress, challenges and regulatory readiness. Journal of Pharmaceutical Policy and Practice 14(1),29