With more than 20 African Union Member States yet to ratify the African Medicines Agency (AMA) Treaty, AIDS Healthcare Foundation (AHF) calls on African governments to accelerate ratification and regulatory harmonisation to expand access to affordable medicines and unlock Africa’s pharmaceutical manufacturing potential.

The call comes as AMA convenes its inaugural week in Kigali, Rwanda, from 25–30 October 2026, against a backdrop of continued dependence on imported medicines, fragmented regulatory systems and growing calls for African health sovereignty.

Africa’s pharmaceutical market is estimated at US$30 billion, yet 70–95% of medicines consumed on the continent are imported. Presentations during AMA Week also highlighted a pharmaceutical trade deficit of approximately US$12.5 billion in 2020. While African countries continue to spend billions importing medicines from India and other global suppliers, fragmented regulatory requirements are constraining local manufacturers’ ability to scale production and access regional markets.

As reported during AMA Week, 33 African Union Member States had ratified the AMA Treaty by October 2026. Accelerating ratification is essential to building a coordinated continental regulatory system that supports local production while ensuring access to safe, effective and quality-assured medical products.

“Africa cannot achieve health sovereignty while remaining heavily dependent on imported medicines and vulnerable to disruptions in global supply chains. We commend AMA for taking this bold step towards a more coordinated regulatory environment,” said Penninah Iutung, AHF Executive Vice President. “We must now translate political commitments into action.

Discussions during AMA Week highlight the practical barriers facing pharmaceutical manufacturers. Eighty percent of the local manufacturers present identified unpredictable regulatory review and approval timelines as a major challenge, 77% cited differing regulatory requirements across African countries, and 54% pointed to duplicated submissions, assessments and inspections.

These barriers increase costs, delay access to medicines and discourage investment in African pharmaceutical production. Harmonised requirements, predictable approval timelines, shared assessments and stronger collaboration among national regulatory authorities could help manufacturers serve multiple markets more efficiently.

“The establishment of AMA is an important investment in Africa’s collective capacity to protect public health and shape the future of global health. Regulatory harmonisation must go hand in hand with technology transfer, research and development, and the strengthening of African scientific institutions,” said Dr Jorge Saavedra, Executive Director of the AHF Global Public Health Institute. Africa’s health sovereignty must move from aspiration to implementation. A strong African Medicines Agency is an important part of that journey.

AHF stands ready to work with African governments, AMA, scientists, universities, civil society and industry to advance a resilient, equitable and self-reliant African health ecosystem.

AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 3.3 million people across 50 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. In January 2025, AHF received the MLK, Jr. Social Justice Award, The King Center’s highest recognition for an organization leading work in the social justice arena. To learn more about AHF, visit us online at AIDShealth.org, find us on Facebook, and follow us on Instagram, Twitter, and TikTok.

Media gallery

About The Author
Business Wire