The African Medicines Agency and the Evolution of Continental Regulatory Systems


Writing in the July 2023 edition of DIA’s Global Forum magazine, Nevena Miletic of Roche and the IFPMA’s Africa Regulatory Network and Ian Hudson from the Bill and Melinda Gates Foundation look back on the progress made towards instituting an African Medicines Agency and the next steps in this important process.


From 22-24 March, key stakeholders in global health gathered in Basel for DIA Europe 2023. Under the theme “Advancing Health Priorities,” this conference aimed to Drive Insights to Action by connecting key policy discussions to real-world knowledge and accelerate growth and performance in the drug development ecosystem.

On 23 March, DIA Europe hosted discussions highlighting the important role of the new African Medicines Agency (AMA) in the evolution of regulatory systems across the African continent. The discussion gathered multidisciplinary experts from the African Union Commission, African Union-New Partnership for Africa’s Development (NEPAD), the European Medicines Agency (EMA), World Health Organization (WHO), the South African Health Products Regulatory Authority (SAHPRA), the Bill and Melinda Gates Foundation, and industry, who shared their thoughts on the establishment of the Agency, its future structure and function, how to facilitate regulatory reliance, and perspectives about how the AMA can deliver its objectives, including how the EMA can assist in establishing the AMA.


The African Medicines Agency: Achievements and Next Steps

Since the Treaty’s adoption on 11 February 2019 by African Heads of States and Government during the 32nd Ordinary Session of the Assembly of the African Union (AU), which was a first step for the AMA establishment, the Agency has achieved many milestones, such as selecting Rwanda as the first country to host the AMA. Furthermore, great progress has been made in improving the African Medicines Regulatory Harmonization Initiative (AMRH), which has served as a building block for continental capacity building and regulatory system strengthening.

Today, 35 of the 55 AU Member States have signed and/or ratified the AMA Treaty, and although not all countries will be able to ratify it within the next five years, the speed at which this process has taken place shows the great interest of the parties involved to have a unified AMA in place as soon as possible.

Key stakeholders and partners pointed at ongoing continental interventions in support of the full operationalization of the AMA and African Medicines Regulatory Harmonisation initiative, including the development of guidance on Priority Medicinal Products for Continental Assessment which was the work of various AMRH Technical Committee drafting procedures to be considered by the future Governing Board and Director General of the AMA (both are yet to be named). Other interventions include a Continental Reliance Framework and the operationalization of a Reliance Laboratory Network for vaccines released on the continent. For these processes to continue, reinforcement from partners is crucial. As long-standing supporters of the AMA, the Bill and Melinda Gates Foundation (BMGF) and the European Medicines Agency (EMA) have committed to backing the vision of the AU and its Member States through initiatives related to regulatory system strengthening and the governance, operationalization, and sustainability of the Agency.


Read the full article on the DIA Global Forum website here

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