The African Union (AU) is urging member states to accelerate ratification of the treaty establishing the African Medicines Agency (AMA), as only 35 of the bloc’s 55 countries have approved the agreement.
The delay poses a challenge to efforts to strengthen Africa’s capacity to regulate medicines, improve access to safe and quality-assured products, and reduce reliance on pharmaceutical supplies from outside the continent.
Dr Michael Sidibé, the AU’s special envoy for AMA, said stronger African-led medicines regulation would help protect public health and give the continent a greater voice in decisions affecting its people.
“Let us support our agency and help it become operational so that we can safeguard our sovereignty. I am not talking about independence through isolation, but rather autonomy based on genuine cooperation, which will enable us to have a voice in negotiations and participate in decisions that affect our people,” he said.
Rwanda is among the countries that have ratified the treaty and hosts AMA’s headquarters in Kigali.
Dr Yvan Butera, Rwanda’s Minister of State for Health, reaffirmed the country’s commitment to supporting the agency and advancing its objectives.
“We are committed to supporting this agency because it is an important and trusted institution that brings countries together to regulate medicines and improve the processes for ensuring their quality across Africa. Rwanda will continue working with AMA and its member states to ensure this milestone brings tangible improvements to people’s health,” he said.
AMA officials said the agency was continuing to implement its mandate despite gaps in the resources and capacity required to achieve its goals.
A key priority is to pool the expertise and regulatory capabilities African countries have developed over the years, enabling them to work together more effectively in overseeing medicines across the continent.
The approach is expected to facilitate the sharing of research findings, speed up regulatory decisions, support pharmaceutical manufacturing and improve coordination in responding to public health emergencies.
Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), has also urged countries that have yet to ratify the treaty to do so, saying collective action is essential to strengthening regulatory systems, particularly in countries with limited capacity.
Africa remains heavily dependent on imported medicines, with more than 70% of the medicines used on the continent sourced from other regions. Meanwhile, only about 1% of the raw materials needed for pharmaceutical manufacturing in Africa are produced locally.
Established in 2019, AMA began operations in 2025. It aims to strengthen medicines regulation, promote cooperation among African countries and improve access to safe, effective and quality-assured medicines across the continent.
