Meeting Highlights: DIA Europe 2023
New Agency for the New Era
African Medicines Agency and the Evolution of Continental Regulatory Systems
Nevena Miletic
Africa Regulatory Network, IFPMA
Ian Hudson
Bill and Melinda Gates Foundation

rom 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.

Importance of Collaboration Among Global Stakeholders

Since the very start of its establishment and operationalization process, many stakeholders (including the private sector) have been strongly in support of an African Medicines Agency, believing that its full fulfillment has the potential to strengthen regulatory ecosystems within the continent over time. Furthermore, a fully operationalized AMA could lead to more focused resources for value-adding activities, the ability to make evidence-based scientific regulatory decisions, and minimize administrative hurdles, allowing for increased use of reliance-based procedures and harmonized regulatory requirements across Africa. This would ultimately enable the acceleration and simplification of patient access to medicines and vaccines across the continent.

It must not be forgotten that this vision will require a conducive environment for innovation, along with relevant stakeholders committing to addressing inequalities that already exist. Engaging industry early into the development of the AMA processes will therefore be key to ensure a smooth transition and allow all stakeholders to understand what is needed.

Collaboration, Convergence, and Regulatory Reliance to Increase Access

Looking at the history of the AMA’s evolution until now, stakeholder engagement and collaboration toward Agency operationalization is of the utmost importance. This engagement must be directed not only toward regulators but also toward industry, who must have confidence in the AMA’s ability to deliver; as well as toward patients, who must have confidence in the AMA’s decision-making. During this discussion, experts noted the progress that has already been observed in harmonization of regional procedures, such as ZaZiBoNa, implementation of reliance practices on the national and regional levels, and establishment of the AMRH Partnership Platform to engage all partners and stakeholders. Progress has already been observed in the harmonization of the regional procedures, implementation of reliance practices on the national and regional levels, and the establishment of the AMRH Partnership Platform to engage all partners and stakeholders. The global, regional, and national health communities must continue this progress and collaborate with one another to ensure efficient access to safe and quality medicines and the use of regulatory best practices around reliance, harmonization of regulatory standards, digitalization, and information sharing.

Overall, for the global and continental community to succeed in fully operationalizing the AMA, the AMA must remain African-owned and driven. Trust must be built among all stakeholders; targets should be focused on small achievable steps and sustainable funding must be prioritized. Through multilateral cooperation, the AMA can finally reach its fullest potential and enable strengthened and harmonized regulatory systems in Africa.