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Guests at the African Medicines Agency (AMA) inaugural week in Kigali.

KIGALI – Africa’s ambition to produce more of the medicines its people need faces an unprecedented challenge of ensuring that quality-assured products can reach patients across national borders without unnecessary regulatory delays.

The continent imports more than 70% of the medicines it uses and almost all its vaccines, leaving the continent dependent on external suppliers even as governments seek to build local pharmaceutical industries and improve access to essential healthcare.

Beyond factories, financing and technology constraints, medicines approved after rigorous scientific assessment in one country may still face separate regulatory processes before it can reach patients in another.

For manufacturers seeking to serve several African markets, such fragmentation can mean duplicated work, unpredictable timelines and additional costs. For patients, it can stand in the way of timely access to essential treatments.

That is the gap the African Medicines Agency (AMA) seeks to close, as regulators, health officials and industry representatives gather in Kigali for the agency’s inaugural week, running from October 25 to 30, 2026.

Dr. Michel Sidibé, the African Union Special Envoy for AMA.

Dr. Michel Sidibé, the African Union Special Envoy for AMA, believes the agency fills a critical gap in Africa’s health system where the absence of a continental regulatory framework capable of strengthening confidence in medicines is missing.

“Fragmented national systems make it harder for locally manufactured products to reach patients across the continent. We need to fight to make sure that AMA becomes a structure which responds to the need of our people,” he said.

If manufacturers must navigate separate regulatory processes across dozens of countries, the costs and uncertainty can discourage investment.

According to Sidibé, a more coordinated system could allow regulators to share scientific assessments, reduce duplication and help quality-assured products reach more markets.

A Continental Market Needs Stronger Regulators

Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization.

The problem is not simply that countries have different rules. It is also that their regulatory institutions have different levels of technical capacity, expertise and resources.

Experts say the solution lies in building credible national systems while enabling authorities to rely on assessments conducted by trusted counterparts.

Shared assessments could significantly shorten the time it takes for products to reach patients, rather than forcing manufacturers to repeat similar processes in every market.

Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO) says that it is also a public-health concern. Fragmented regulatory systems can delay access to medicines, increase costs and weaken countries’ ability to respond to health threats.

“WHO is working with AMA to strengthen national regulatory authorities and advance regulatory convergence, including through shared assessments and reliance on work undertaken by trusted agencies,” Dr. Tedros said.

According to him, the goal is to help countries make better use of available scientific expertise without compromising the standards required to protect patients.

Rwanda’s Minister of State for Health, Dr. Yvan Butera, brought that responsibility down to the level of everyday experience of a mother taking her child for vaccination, a patient filling a prescription or a health worker preparing treatment.

“Confidence in the quality and safety of the medicine is essential. Stronger cooperation between regulators can extend that protection across borders, helping ensure that patients benefit from reliable oversight regardless of where they live,” Butera argued.

Two Hubs Launched in Rwanda.

Prof. Paul Lalvani, Executive Director of Empower School of Health.

Two hubs intended to turn the continental ambition into practical work have been launched in Rwanda. They are the Capacity Strengthening hub and the Regulatory Innovation and Manufacturing Readiness hub.

Prof. Paul Lalvani, Executive Director of Empower School of Health, said their significance lies in addressing the shortage of people and institutions capable of operating it effectively, a weakness that can persist even when governments invest in infrastructure.

Drawing on two decades of health-sector capacity-building experience, Lalvani explained that training individuals alone is insufficient. Countries also need institutions that retain expertise, develop professionals and continue improving after external support ends.

“You can build plants, which takes time, but building people and strengthening people takes even longer. The hubs offer an opportunity to connect countries and share proven practices and spread expertise across the continent,” Lalvani said.

The manufacturing-readiness hub is intended to engage innovators and businesses earlier in product development, helping them understand regulatory requirements before products reach formal assessment.

Lalvani said Africa should learn from sectors where it has developed world-class skills, citing football academies as an example of what sustained investment in people and learning systems can achieve.

Measuring Success in Medicines Made in Africa

Specialists say the ultimate measure of success should not be the number of workshops held or institutions established, but whether Africa becomes less dependent on imported medical products.

“The real metric is how self-reliant Africa is when it comes to local manufacturing of pharmaceuticals, vaccines, medical devices and medical diagnostics,” Lalvani said.

The African Continental Free Trade Area, stronger national regulators and AMA could reinforce one another by establishing improved regulatory capacity, support product quality and better-coordinated processes to make it easier for manufacturers to reach a wider market.

But that outcome will depend on sustained government investment in skilled personnel, stronger national institutions and the continental agency itself.

Regulatory gaps between countries could leave openings for unsafe and falsified medicines to circulate, undermine the protection that stronger systems elsewhere are intended to provide.

Beyond encouraging production of more medicines on the continent, AMA intends to build the expertise, trust and regulatory cooperation that will allow quality-assured medicines to reach the people who need them, more safely and without unnecessary delays.

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