The Cabinet Secretary for Health, Adan Duale, has reaffirmed Kenya’s commitment to regulatory harmonisation of medical products in Africa through the Africa Medicines Agency (AMA) for the continent to achieve health sovereignty and reduce over-reliance on imports.
Speaking in Mombasa during the 7th Biennial Scientific Conference on Medical Products Regulation in Africa, Duale underscored the need to align rules governing the medical products sector to enable large-scale manufacturing, facilitate intra-African trade, and guarantee uninterrupted access to safe and quality health products.
The CS said the COVID-19 pandemic exposed Africa’s vulnerability when global supply chains collapsed, leaving the continent waiting for essential medical supplies.
He emphasised that Africa must now shift from being a net importer to a reliable, large-scale producer of quality vaccines, therapeutics, diagnostics, and medical devices.
“The master key to this shift is regulatory harmonisation, which converts 55 fragmented markets into one investable opportunity under the African Continental Free Trade Area (AfCFTA),” stated Duale.
He highlighted reforms in Kenya’s health sector, including end-to-end digitisation through a health digital superhighway that connects identity, clinical records, supply chains, and real-time analytics.
Other measures include strengthening commodity security through a robust KEMSA, vibrant local manufacturing, and sound health financing to ensure affordable, quality-assured products reach the last mile.
“Regulation is the enabling architecture. Divergent requirements across borders keep Africa small; harmonised standards make Africa a single, credible market,” said the CS.
“AMA is our continental leap, an institution designed to be rigorous, predictable, and innovation-friendly, accelerating access while safeguarding quality and safety. When standards converge, investment follows; when investment arrives, jobs, resilience, and technology transfer follow.”
He urged the 24 remaining African Union member states to ratify the AMA treaty to operationalise the agency and leverage AfCFTA to unlock intra-African trade in quality-assured health products.
“Pooled procurement, mutual recognition, and common technical standards will shorten time-to-market, reduce regulatory duplication, and attract manufacturers to build plants where policy certainty is strongest,” he said.
The CS asserted that Kenya is strengthening its national regulatory authority toward global benchmarks, digitising review pathways, and integrating quality systems from clinical-trials oversight to post-market surveillance.
“Our objective is simple: an authorisation in Kenya should inspire confidence anywhere in Africa, and our data should flow securely along the digital superhighway we are building,” he stated.
He added, “Factories cannot stand on soft ground. We are tightening governance of procurement, track-and-trace, and anti-counterfeit systems so that every shipment is verifiable from production line to patient. Transparent, digital, end-to-end visibility protects patients, reassures investors, and makes public finance count twice.”
Pharmacy and Poisons Board Chairman Dr John Munyu warned that Africa remains in a precarious position, importing 90 per cent of its medicines and producing less than 1 per cent of its vaccines.
“This is a critical weakness we must address as a continent. Over the past 10 years, the Africa Medicines Regulatory Harmonisation Programme has been the cornerstone of our efforts to build robust regulatory systems from the national to the regional level through guideline harmonisation and digitalisation,” said Dr Munyu.
He called for support for AMA to catalyse local manufacturing, facilitate trade under the AfCFTA and ensure that quality medical products reach everyone in need on the continent.
“The potential for Africa is undoubtedly great, and strengthening our ability to manufacture and engage in intra-African trade of health products is well within our reach. Achieving this will require strong collaboration across the continent,” he stated.
Mombasa Governor Abdulswamad Nassir also called for the regulation of emerging technologies like Artificial Intelligence (AI) in the health sector to protect patients.
“Regulation of the medical industry should not just be limited to tablets and syrups alone. I think we also need to be able to expand into regulating algorithms, regulating medical health apps that are out there, and regulating AI solutions when it comes to health, because that is what is happening right now, where people have ceased going to a doctor and just prefer to be able to go to a mobile app or to go anywhere else,” elaborated Nassir.
By Sadik Hassan
