he African Medicines Agency (AMA) is paving the way for Africa to achieve regulatory self-sufficiency and reliance. By aligning with global standards, this continent-wide regulatory ecosystem is expected to revolutionize patient care and access to medicinal products across Africa in new and unprecedented ways.

During DIA Europe 2024, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) organized an Africa Townhall session in collaboration with the European Medicines Agency (EMA) which brought together various regulatory experts from the African Union Development Agency-NEPAD, the World Health Organization (WHO), the Bill and Melinda Gates Foundation, the Economic Community of West African States (ECOWAS), and industry. It revolved around the progress of different partners to enrich Africa’s regulatory ecosystem by implementing a robust and modern AMA.

Foundations for Operationalization

Adopted by the African Union (AU) in 2019 and ratified to date by 26 countries, a continental agency, the AMA, was established to support local pharmaceutical production, coordinate joint assessment procedures, and enable timelier collaboration between Regional Economic Communities (RECs) and national regulatory authorities (NRAs) for access to safe, quality, efficacious medicines and vaccines across the continent. In so doing, AMA can help improve patient outcomes and safeguard against the use of falsified and substandard medicines.

The success of the AMA will depend on its operationalization, and on how African NRAs leverage the experience and learnings of mature regulatory agencies, including the EMA, and international work-sharing schemes. During the Townhall discussions, experts identified several foundational drivers for operationalizing the AMA:

• Technical support: The Africa Medicines Regulatory Harmonisation (AMRH) initiative is a cornerstone of Africa’s regulatory ecosystem. Enacted in 2012, AMRH builds regulatory capacity and cultivates an enabling environment for research and development while adhering to international standards for quality, safety, and efficacy.

  Through tremendous, stepwise effort, the AMRH initiative has since been implemented in most African regions, allowing for work-sharing and learning across the continent. Most recently, the AMRH has spearheaded the revision of the AU Model Law on Medical Products Regulation, the development of continental guidelines and procedures for the listing of medical products, and the establishment of a continental infrastructure management system for the exchange of regulatory information. This modernization will increase efficiency and help accelerate continent-wide exchange of knowledge and technical information and expertise amongst regulators and beyond.

• Digitalization: Digital tools and technology solutions have the potential to revolutionize regulatory processes by making them more efficient, transparent, and accessible. This has led to an increased adoption of digitalization in regulatory operations, which has proven to be a transformative enabler. This is seen at the continental level through various projects led under the AMRH with the development of a continental Regulatory Information Sharing Portal, Regulatory Information Management System, Electronic Continental Regulatory Experts System, and Continental Active Pharmaceutical Ingredients Database. The Economic Community of West African States (ECOWAS) region is also putting in place an Electronic Common Technical Document (eCTD) that is being piloted in several West African countries (Benin, Cabo Verde, Côte d’Ivoire, Ghana, Liberia, Nigeria, Senegal, and Togo) and will contribute to increased efficiency of regulatory processes at the regional level.
• Pilot and capacity-building programs: The Continental Listing of Human Medicinal Products pilot was launched in November 2023 and is a first-of-its-kind pilot to test the robustness of the regulatory reliance processes put in place by the AMRH technical committees and is an opportunity for all stakeholders, including industry, to shape the process together. Insights from pilots are pivotal for shaping the establishment of AMA and propelling regulatory harmonization efforts forward.
  Discussants reaffirmed that AMA is not positioned to supplant RECs or NRAs, but rather to complement and coordinate specific aspects of their work, providing continent-wide recommendations, guidance, and technical support for complex products. National and regional capacity-building initiatives help enhance regulatory expertise and technical capabilities across the continent. To date, 11 Regional Centres of Regulatory Excellence (RCORES) have been implemented and will continue to be strengthened across countries to develop qualified African regulatory professionals. Support from the WHO has also facilitated regulatory framework strengthening, for example enabling Tanzania and Ghana to reach Maturity Level 3 (ML3) for medicines, South Africa and Egypt to reach ML3 for vaccine regulation, and Nigeria to reach ML3 for medicines and imported vaccines.
  These mature regulatory authorities are expected to serve as lighthouses for neighboring NRAs, guiding regulatory evolution across the continent to better deliver on the vision of AMA. However, regulatory reliance and work sharing, as mentioned above, should be considered by NRAs no matter their resource capacity or maturity levels.
• Stakeholder engagement and collaboration: Collaboration between regulatory agencies, international funding and technical partners, industry stakeholders, policymakers, and patient advocacy groups emerged as indispensable for advancing regulatory harmonization and building a solid framework for the continent. All stakeholders have a collective responsibility in fostering a spirit of cooperation to expedite access to safe and efficacious medicinal products for all patients across the continent.

Achieving a Mature and Collaborative Regulatory Environment

With a concerted focus on bolstering regulatory capacity, fostering collaboration, and embracing digitalization, Africa is positioned to forge a sustainable, equitable regulatory ecosystem: a new gold standard in regulatory excellence for the benefit of all patients in Africa.

This new model of excellence, encapsulated by AMA, is becoming real. Rwanda was recently designated as the host country of AMA, and we have since seen the establishment of the Board of Directors, presided over by the Food and Drugs Administration of Benin. Next, we expect the appointment of the Director General, who will, together with the Board, define AMA’s initial scope and regulatory procedures for the successful operationalization of this continental agency.