Kigali, Rwanda | 26 August 2026

The African Medicines Agency (AMA) has welcomed the new strategy by African Ministers of Health to bolster medical products regulatory systems in Africa. The strategy envisages a critical role for AMA towards regulatory harmonisation and health improvement in Africa.  

The Regional Strategy on Regulation of Medical Products in the African Region (2026–2035) provides a roadmap for the next decade. Its adoption comes at a critical time as AMA accelerates efforts to advance regulatory harmonisation. 

The adoption marks an important step towards expanding equitable access to quality-assured health products across the continent and further advancing the mandate of the AMA. 

The AMA became operational in October 2025 and operates from its Headquarters in Kigali, Rwanda. AMA is working with National Regulatory Authorities(NRAs) and Regional Economic Communities(RECs) to enhance their capacity to regulate medical products to improve access to quality, safe and efficacious medical products on the continent. AMA is also working with NRAs to facilitate the, scale up of local manufacturing and prepare for future health emergencies. 

The WHO AFRO strategy sets out to strengthen the African Medicines Agency’s role as the continent’s coordinating regulatory body, increase the number of authorities reaching WHO Maturity Level 3, improve preparedness for public health emergencies, and scale the use of digital regulatory systems. 

“By 2035, success should be an African system that countries trust, local manufacturers can navigate and patients experience through faster access to quality-assured medical products. AMA is ready to play its part.” said Dr. Delese Mimi Darko, Director General, African Medicines Agency (AMA).  

The region has been laying the foundations to harmonise regulation across borders and build on the momentum of a continental coordinator. Beginning with the groundwork of African Medicines Regulatory Harmonisation (AMRH) Initiative and the African Vaccines Regulatory Forum (AVAREF), regulatory harmonisation has advanced steadily, from shared technical standards to joint reviews across borders. 

The number of national regulatory authorities reaching WHO Maturity Level 3 has risen from one in 2018 to ten in 2026. (WHO) While most African regulatory agencies hold considerable technical expertise, they still need to strengthen capacity as no single authority can meet today’s regulatory demands alone. AMA pools that expertise into one predictable continental system, complementing national regulators rather than competing with them. 

The strategy is a clear signal of continental commitment to a shared and effective regulatory system. AMA stands ready to play a central role in its implementation and delivery over the coming decade.