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

Abstract

Insufficient access to quality, safe, efficacious and affordable medical products in Africa has posed a significant 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 ineffective regional collaborations among NMRAs. In response to national regulatory challenges in Africa, a number of regional harmonisation efforts 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 ratified 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 effective medicines regulation by galvanising technical support, regulatory expertise and resources at a continental level. Furthermore, this review provides recommendations for future research.

COVID-19 vaccine access in Africa: Global distribution, vaccine platforms, and challenges ahead

“…This harmonized regional approach will ensure timely access to safe and effective new medical products delivered by African health systems for routine care, and approval for emergency use during outbreaks. The pace must however be accelerated to bring AMA to existence; two years after the adoption of the treaty that marked its creation at the 32nd ordinary session of the Assembly AU, only 8 countries out of the of the 15 required have ratified the document ( Ncube, Dube and Ward, 2021 ).…”

Where National Medicines Policies Have Taken Us With Patient Involvement and Health Technology Assessment in Africa

“…It is hoped that the activities of the AMA can become patient-centric and that it can build patient engagement into its regulatory framework by applying laws, policies, practices, and standards. Building expertise and capacity is a vital part of the vision of the AMA (49,50). For some, it is important for medical regulators to involve patients and the public across the spectrum of their work (49,51).…”

COVID-19 vaccine equity: a health systems and policy perspective

“…While in Europe, the European Medicines Agency takes this role, such a regulatory agency will have to be strengthened for the regional manufacturing hubs in Africa. Capacity development and a governance structure to do so need to be developed in close collaboration with the AU, the African CDC, and the, to be established, African Medicines Agency (AMA) [ 87 ].…”