Africa imports more than 70% of the medicines its people use and almost all its vaccines, creating heavy dependence on external suppliers despite government efforts to build local pharmaceutical industries. The continent's fragmented regulatory systems compound this challenge: medicines approved after rigorous scientific assessment in one country often face separate regulatory processes before reaching patients in another. For manufacturers seeking to serve multiple African markets, this fragmentation means duplicated work, unpredictable timelines and additional costs that can discourage investment in the continent's health sector.
The African Medicines Agency (AMA) held its inaugural week in Kigali from October 25 to 30, 2026, bringing together regulators, health officials and industry representatives to address this gap. Dr. Michel Sidibé, the African Union Special Envoy for AMA, said the agency fills a critical gap where the continent lacks a continental regulatory framework capable of strengthening confidence in medicines. He explained that fragmented national systems make it harder for locally manufactured products to reach patients across the continent, and stressed that AMA must respond to the needs of African people.
The World Health Organization said fragmented regulatory systems can delay access to medicines, increase costs and weaken countries' ability to respond to health threats. Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, said the solution lies in building credible national systems while enabling authorities to rely on assessments conducted by trusted counterparts. He noted that 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, helping countries make better use of available scientific expertise without compromising standards that protect patients.
Rwanda's Minister of State for Health, Dr. Yvan Butera, connected the issue to everyday patient experiences, saying that confidence in medicine quality and safety is essential. He argued that stronger cooperation between regulators can extend that protection across borders, helping ensure patients benefit from reliable oversight regardless of where they live. Two hubs have been launched in Rwanda to turn continental ambition into practical work: the Capacity Strengthening hub and the Regulatory Innovation and Manufacturing Readiness hub.
Prof. Paul Lalvani, Executive Director of Empower School of Health, said the hubs' significance lies in addressing the shortage of people and institutions capable of operating regulatory systems effectively. He explained that training individuals alone is insufficient; countries also need institutions that retain expertise, develop professionals and continue improving after external support ends. 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 the real measure of success should be whether Africa becomes less dependent on imported medical products, stating that the metric is how self-reliant Africa becomes when it comes to local manufacturing of pharmaceuticals, vaccines, medical devices and medical diagnostics.