AHF Urges African Governments to Accelerate African Medicines Agency Treaty Ratification to Strengthen Pharmaceutical Independence
AIDS Healthcare Foundation Calls for Regulatory Harmonisation to Expand Access to Affordable Medicines and Boost Local Pharmaceutical Manufacturing Across Africa
AIDS Healthcare Foundation (AHF) is urging African governments to accelerate ratification of the African Medicines Agency (AMA) Treaty and strengthen regulatory harmonisation across the continent to improve access to affordable, high-quality medicines and unlock Africa’s pharmaceutical manufacturing potential. With more than 20 African Union (AU) Member States still yet to ratify the treaty as of October 2026, AHF is calling for stronger political commitment and coordinated action to establish a more unified regulatory environment that supports public health, local production and long-term health sovereignty.
The call comes as the African Medicines Agency convenes its inaugural week in Kigali, Rwanda, from October 25–30, 2026. The gathering takes place amid continued reliance on imported medicines, fragmented national regulatory systems and increasing efforts to strengthen Africa’s ability to meet its own healthcare needs. Discussions during AMA Week have highlighted the importance of building a coordinated continental framework that enables African countries to improve medicine availability, strengthen pharmaceutical manufacturing and reduce vulnerabilities associated with international supply chains.
AHF emphasises that accelerating the treaty’s ratification is a critical step towards establishing a more integrated regulatory system capable of supporting the development of Africa’s pharmaceutical industry while maintaining rigorous standards for the safety, efficacy and quality of medical products.
Africa’s Dependence on Imported Medicines Highlights the Need for Change
Africa’s pharmaceutical market is estimated to be worth approximately US$30 billion, presenting significant opportunities for local manufacturers, investors, researchers and healthcare stakeholders. Despite the size of the market, however, an estimated 70% to 95% of medicines consumed across the continent are imported. This dependence leaves many African countries exposed to international supply chain disruptions, fluctuations in procurement costs and challenges associated with ensuring a consistent supply of essential medicines.
Presentations delivered during AMA Week also highlighted Africa’s pharmaceutical trade deficit, which stood at approximately US$12.5 billion in 2020. The figure underscores the considerable gap between the continent’s pharmaceutical consumption and its domestic production capacity.
African countries continue to spend billions of dollars importing medicines from India and other international suppliers. Although these imports remain essential to meeting healthcare needs, the high level of dependence highlights the need to strengthen domestic manufacturing capabilities and establish more resilient pharmaceutical supply chains.
Expanding local production could help African countries improve the availability of essential medicines, create opportunities for skilled employment, encourage technology transfer and strengthen the continent’s capacity to respond to public health emergencies. It could also provide manufacturers with opportunities to develop products tailored to regional healthcare priorities.
However, increasing production requires more than investment in manufacturing facilities. Pharmaceutical companies must be able to navigate regulatory systems efficiently, obtain timely approvals and distribute products across national borders without facing unnecessary administrative barriers.
AHF argues that a coordinated regulatory framework is essential to addressing these challenges and creating the conditions necessary for a competitive and sustainable African pharmaceutical sector.
Treaty Ratification Is Central to Building a Unified Regulatory Framework
As reported during AMA Week, 33 African Union Member States had ratified the AMA Treaty by October 2026. The remaining countries are being urged to accelerate the ratification process to strengthen the agency’s continental mandate and advance regulatory cooperation.
The African Medicines Agency is intended to support the harmonisation of medicine regulation and improve coordination among national regulatory authorities. By promoting consistent regulatory approaches and facilitating collaboration, the agency can help reduce duplication, improve efficiency and strengthen oversight of medical products throughout Africa.
Fragmented national systems can require manufacturers to meet different requirements when seeking approval for the same medicine in multiple countries. These differences can increase development and compliance costs, extend review timelines and complicate efforts to introduce products across regional markets.
A more harmonised approach could help address these challenges by encouraging common standards, coordinated assessments and greater information-sharing among national regulators. Such measures could reduce unnecessary administrative burdens while preserving each country’s responsibility to protect public health.
For manufacturers seeking to expand beyond their domestic markets, greater regulatory predictability could make Africa a more attractive destination for pharmaceutical investment. Companies could plan product launches and manufacturing operations more efficiently, while healthcare systems could benefit from improved access to medicines that meet established quality and safety standards.
AHF maintains that ratification must be accompanied by practical implementation. Governments, regulators and industry stakeholders will need to work together to translate the treaty’s objectives into measurable improvements in regulatory performance and medicine availability.
Regulatory Barriers Continue to Challenge Local Manufacturers
Discussions during AMA Week highlighted the regulatory difficulties that African pharmaceutical manufacturers face when operating across multiple jurisdictions. Feedback presented during the gathering indicated that 80% of local manufacturers represented identified unpredictable regulatory review and approval timelines as a major challenge.
In addition, 77% cited differences in regulatory requirements between African countries, while 54% pointed to duplicated submissions, assessments and inspections.
These findings illustrate how fragmented regulatory systems can constrain the growth of local pharmaceutical businesses. Manufacturers may be required to prepare separate applications, provide similar information to multiple authorities and undergo repeated assessments for products intended for different national markets.
Such processes can consume financial and human resources that could otherwise be directed towards research and development, manufacturing improvements, quality assurance and the expansion of production capacity.
Unpredictable approval timelines can also complicate business planning. When companies cannot reliably estimate how long a regulatory review will take, they may face difficulties coordinating manufacturing schedules, managing inventories and determining when products can enter new markets.
For smaller manufacturers, the cumulative cost of navigating multiple regulatory systems may be particularly burdensome. These challenges can discourage investment and limit the ability of African companies to compete effectively with established international suppliers.
Harmonisation offers a potential route to reducing these obstacles. Greater alignment of technical requirements, more predictable review procedures and increased cooperation between national regulatory authorities could help manufacturers avoid unnecessary duplication and serve several markets more efficiently.
At the same time, harmonisation must not come at the expense of product quality or patient safety. Strong regulatory oversight remains essential to ensuring that medicines available to African populations are safe, effective and manufactured according to appropriate quality standards.
The objective is to create a system that combines robust public health protections with efficient, transparent and predictable regulatory processes.
AHF Calls for Health Sovereignty Through Collaboration and Investment
Penninah Iutung, Executive Vice President of AHF, highlighted the relationship between pharmaceutical independence, supply chain resilience and the establishment of a coordinated regulatory environment.
“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,” Iutung said. “We must now translate political commitments into action.”
Her remarks reflect AHF’s position that African governments must move beyond commitments and prioritise concrete measures to strengthen the continent’s pharmaceutical capabilities.
Health sovereignty involves building the institutional capacity, scientific expertise, manufacturing infrastructure and regulatory systems needed to meet public health requirements more independently. It does not necessarily mean eliminating international trade, but rather reducing excessive dependence on external suppliers and improving the ability of African countries to secure essential medical products during periods of disruption.
A stronger regional pharmaceutical industry could contribute to this objective by increasing local production, improving supply chain resilience and creating a more diversified source of medicines for healthcare systems.
Achieving these goals will require sustained investment, cooperation among governments and greater coordination between regulators, research institutions, universities, manufacturers and civil society organisations.
Technology Transfer and Research Must Complement Harmonisation
Dr Jorge Saavedra, Executive Director of the AHF Global Public Health Institute, stressed that the establishment of AMA represents an important investment in Africa’s collective ability to protect public health and influence the future direction of global health.
“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,” Saavedra said.
He added that Africa’s health sovereignty must move from aspiration to implementation, describing a strong African Medicines Agency as an important component of that process.
His comments highlight the need to address the broader factors that determine pharmaceutical manufacturing capacity. Regulatory reform can make it easier for manufacturers to operate across national markets, but companies also need access to appropriate technologies, trained personnel, reliable infrastructure, financing and research capabilities.
Technology transfer could help African manufacturers strengthen production processes, develop technical expertise and improve their ability to manufacture a wider range of medicines. Investment in research and development could also support the development of products addressing the continent’s specific disease burdens and healthcare priorities.
Universities, scientific institutions and research organisations have an important role in building the knowledge base required to support these activities. Stronger partnerships between research institutions and pharmaceutical companies could help translate scientific discoveries into commercially viable products and improve the long-term sustainability of local manufacturing.
The development of skilled regulatory professionals is equally important. National regulatory authorities will need sufficient technical expertise, resources and institutional capacity to participate effectively in harmonised processes and maintain high standards of oversight.
By combining regulatory cooperation with scientific investment and technology transfer, African countries could establish a stronger foundation for pharmaceutical innovation and production.
Collaboration Needed to Turn Commitments Into Results
AHF has expressed its readiness to work with African governments, the African Medicines Agency, scientists, universities, civil society organisations and industry stakeholders to advance a resilient, equitable and self-reliant African health ecosystem.
Such collaboration will be important as countries work to ratify the treaty, strengthen regulatory institutions and develop practical approaches to harmonisation. Progress will depend on sustained political support, effective coordination and a shared commitment to ensuring that regulatory improvements translate into tangible public health benefits.
Priority areas include accelerating treaty ratification, improving the predictability of medicine approval timelines, reducing unnecessary duplication in regulatory submissions and assessments, and strengthening cooperation among national authorities.
Equally important will be efforts to expand pharmaceutical manufacturing, support research and development, facilitate technology transfer and develop the scientific workforce required to sustain the industry.
If implemented effectively, these measures could help African manufacturers reach more markets, improve the availability of quality-assured medicines and encourage investment in the continent’s pharmaceutical sector.
For patients and healthcare providers, stronger domestic and regional manufacturing capacity could contribute to more reliable medicine supplies and reduce exposure to disruptions in international procurement. For governments, it could support broader efforts to improve healthcare resilience and strengthen preparedness for future public health emergencies.
The success of the African Medicines Agency will ultimately depend on the willingness of AU Member States to translate shared objectives into coordinated action. Accelerating treaty ratification is an essential starting point, but meaningful progress will also require implementation, investment and sustained cooperation across the pharmaceutical value chain.
With Africa continuing to rely heavily on imported medicines despite its substantial pharmaceutical market, the push for regulatory harmonisation represents an important opportunity to strengthen local production and improve access to affordable treatments.
AHF’s appeal during AMA Week reinforces the need for African governments to prioritise a coordinated regulatory system that protects patients, supports manufacturers and advances long-term health sovereignty.
About AIDS Healthcare Foundation
AIDS Healthcare Foundation (AHF) is the world’s largest HIV/AIDS healthcare organisation, providing cutting-edge medicine and advocacy to more than 3.3 million people across 50 countries. Its operations span the United States, Africa, Latin America and the Caribbean, the Asia-Pacific region, and Eastern Europe.
AHF works to expand access to healthcare services and support initiatives that address public health challenges through treatment, advocacy and related programmes. Its activities include efforts to promote equitable access to medicines and strengthen healthcare systems for underserved populations.
In January 2025, AHF received the Martin Luther King Jr. Social Justice Award, the King Center’s highest recognition for an organisation leading work in the social justice arena.
For more information, visit the official AHF website at AIDShealth.org. The organisation also shares updates through its social media channels, including Facebook, Instagram, X, and TikTok.