Health CS Aden Duale has urged African nations to fast-track the harmonisation of medical product regulations through the Africa Medicines Agency.
He said the move is key to achieving health sovereignty and reducing dependence on imports.
Duale said Africa’s heavy reliance on external suppliers became evident during the Covid-19 pandemic when global supply chains collapsed, leaving the continent vulnerable.
He was speaking in Mombasa during the 7th Biennial Scientific Conference on Medical Products
Regulation in Africa.
He called for collective action to transform Africa from a net importer to a reliable producer of vaccines, diagnostics, therapeutics 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),” Duale said.
He said Kenya is already making strides through reforms such as full digitisation of the health sector, strengthening of Kemsa, and promotion of local manufacturing to ensure affordable and quality-assured products reach all Kenyans.
“Regulation is the enabling architecture. Divergent requirements across borders keep Africa small; harmonised standards make Africa a single, credible market,” the CS said.
Duale described Africa Medicines Agency (AMA) as a game changer that will create a predictable, innovation-friendly environment and accelerate access to safe and effective medical products.
He urged the 24 remaining AU member states yet to ratify the AMA Treaty to do so, enabling the agency’s full operationalisation.
“Pooled procurement, mutual recognition and common technical standards will shorten time-to-market, reduce regulatory duplication, and attract manufacturers to invest where policy certainty is strongest,” the CS said.
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 one 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,” he said.
Munyu called for support for AMA to catalyse local manufacturing, facilitate trade under the AfCTA and ensure 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 said.
Mombasa Governor Abdulswamad Nassir also called for the regulation of emerging technologies like artificial intelligence 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 algorithmism, regulating medical health apps that are out there, 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.”
Instant analysis
CS Aden Duale’s remarks in Mombasa underscore Africa’s urgent need to harmonise medical product regulations through the Africa Medicines Agency. His call aligns with the broader vision of the African Continental Free Trade Area (AfCFTA), transforming fragmented markets into a single, investable health economy.
