African Medicines Agency Debuts at the African Union Summit
After years of regulatory harmonisation, the African Medicines Agency (AMA)’s debut at the AU Summit marks a landmark moment for medicines regulation, signaling its transition to full institutional authority. The AMA is set to improve access to quality, safe and efficacious medical products in Africa.
Africa’s ambition to ensure access to safe, effective, and quality-assured medicines has long been constrained by fragmented regulatory systems. Differing national standards, limited technical capacity, and weak harmonisation have made it difficult to guarantee timely access to essential medical products while safeguarding public health. These challenges have also slowed the growth of local pharmaceutical manufacturing and intra-African trade of medical products, highlighting the urgent need for a strong, standalone continental regulatory body.
The establishment of the African Medicines Agency (AMA) is a decisive response to this need. Yet, its presence at the African Union Summit (AU Summit) on 13 February 2026 marked more than just another institutional milestone, it represented a true full circle moment for Africa’s medicines regulatory journey.
For over a decade, the African Medicines Regulatory Harmonization (AMRH) programme, led by African Union Development Agency (AUDA-NEPAD), worked to align regulatory frameworks, strengthen technical capacity, and foster collaboration across countries and regions. This groundwork laid the foundation for AMA’s creation. In January 2026, the formal handover of the AMRH Initiative from AUDA-NEPAD to AMA signalling its transition to full institutional authority.
Just weeks later, AMA stepped onto the continental political stage for the first time at the AU Summit, convening a High-Level Presidential Breakfast, directly engaging Heads of State to advance its mandate and regulate medical products to improve access to quality, safe and efficacious medical products in Africa.
The engagement focused on accelerating the ratification of the AMA Treaty in AU Member States, mobilising sustainable financing, and anchoring regulatory harmonisation within Africa’s broader development agenda under Agenda 2063. It demonstrated growing political recognition that strong regulatory systems are essential for health security, timely response to disease outbreaks, and trusted intra-African trade of safe African-manufactured health products.
This milestone was not achieved overnight. AMA’s moment at the AU Summit is the result of years of sustained coordination, technical collaboration, and strong partnerships that helped transform a vision into an operational reality.
Among these, GIZ has played a role in supporting AMRH to pave the way for AMA. Through strategic convenings, such as the 2024 AMRH Week and the 2025 Scientific Conference on Medical Product Regulation in Africa, GIZ helped bridge the transition by bringing together national regulatory authorities and regional initiatives, fostering alignment and a shared continental vision.
GIZ also supported the establishment of a Mutual Reliance Framework among Africa’s World Health Organization (WHO) Maturity Level 3 NRAs, Africa Centres for Disease Control and Prevention, and AUDA-NEPAD, formalised through a Memorandum of Understanding signed in February 2025. By introducing common application and evaluation processes, the framework strengthens collaboration and streamlines regulatory decision-making, helping to accelerate the approval of medicines, vaccines, and other medical products, and ultimately improving timely access across the continent.
In parallel, GIZ has supported key technical workstreams, including strengthening clinical trials oversight and addressing substandard and falsified medical products. Support to practical regulatory activities, such as the continental assessment of mpox diagnostic kits for emergency use listing, demonstrates the real-world impact of coordinated systems. The subsequent continental approval and adoption by member states enabled faster and broader access to these diagnostics during the mpox outbreak.
Building on these major achievements by the AMRH Initiative and National Regulators, AMA’s engagement at the AU Summit is therefore more than a debut; it is the culmination of a decade-long journey and a signal of what lies ahead. As AMA moves forward, sustaining this momentum will require continued investment, collaboration, and commitment. GIZ remains dedicated to supporting AMA in this next phase - building on past achievements to strengthen regulatory systems across Africa and ensure access to safe, quality-assured medicines for all.