The upcoming Seventh Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII) represents a pivotal moment in Africa's quest for health sovereignty. This author explores how the Mombasa conference will address critical regulatory harmonisation challenges, potentially transforming the continent's ability to manufacture and distribute its own medical products, reduce dependency on imports.
Image: IAN LANDSBERG Independent Newspapers
Chimwemwe Chamdimba is the Head of the African Medicines Regulatory Harmonisation Programme at the African Union Development Agency.
Image: File
Africa’s health sovereignty hangs in the balance. When policymakers, regulators, scientists and industry leaders converge in Mombasa, Kenya, for the 7th Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII), they’ll tackle the defining question of our generation: Can the continent forge true health independence?
Under the banner of Regulatory Harmonisation: Unlocking Africa’s Potential in Health Product Manufacturing and Trade, this three-day gathering (from 11 to 13 November 2025) represents more than a conference, as it’s a collective commitment to build the institutions, systems and trust that will secure Africa’s health future. Organised by the African Union Development Agency (AUDA-NEPAD) in collaboration with the World Health Organization, the African Union Commission, Africa CDC and the African Medicines Agency (AMA), SCoMRA VII stands as Africa’s premier platform for evidence-based dialogue and policy alignment in medical products regulation.
It brings together over 500 delegates from across Africa and beyond, reaffirming that health regulation is not a technical exercise but a cornerstone of the continent’s economic and developmental agenda.
For decades, Africa’s health challenges have been defined by access, affordability and dependency on global supply chains. Yet behind every imported medicine or delayed vaccine lies a deeper problem of fragmented regulatory systems that slow down approval, stifle innovation and deter investment.
More than 90 percent of medicines used in Africa are imported, while less than one percent of vaccines are produced locally. This imbalance leaves the continent exposed to external shocks, pricing disparities, and shortages in times of crisis.
When health emergencies strike, as the world saw during the COVID-19 pandemic, Africa often finds itself last in line for life-saving products. The absence of harmonised regulatory systems means a medical product approved in one country can take years to gain approval in another, even when both face the same health threats. This inefficiency costs lives and undermines the continent’s ability to act decisively during crises.
SCoMRA exists to change this reality. Since its inception, the conference has driven the African Medicines Regulatory Harmonisation (AMRH) programme, which supports member states in aligning systems and processes so that medical products can be efficiently evaluated and approved across borders. This initiative laid the foundation for the African Medicines Agency, Africa’s first continental body mandated to ensure that all medical products meet global standards of safety, efficacy and quality.
The 6th SCoMRA, held in Egypt in 2023, was a turning point. It marked the operationalisation of the Continental Reliance Framework, the launch of digital platforms such as e-CRES and RISP, and the creation of a Technical Committee to address substandard and falsified products. These achievements signalled a move from vision to implementation, anchoring Africa’s regulatory progress in accountability and measurable outcomes.
SCoMRA VII in Mombasa builds on this momentum. The discussions will explore how harmonised regulation can unlock industrial growth, accelerate access to medicines and strengthen health security. The focus will not only be on aligning policies but also on ensuring that regulation serves citizens and industries alike. The conference will address critical questions such as how Africa can strengthen regulatory capacity without adding bureaucracy, how local manufacturers can be supported to meet international standards and how digital tools can enhance transparency and efficiency.
The three-day event will open with an address by Kenya’s Cabinet Secretary for Health, Hon. Aden Duale, and will feature participation from some of Africa’s leading health figures. Among the keynote speakers are Dr Delese Mimi Darko, Director General of the African Medicines Agency; Dr Jean Kaseya, Director General of Africa CDC; Professor Mohamed Janabi, Regional Director of WHO AFRO; and Amma Adomaa Twum-Amoah, Commissioner for Health at the African Union Commission.
The opening session, moderated by Mr Symerre Grey-Johnson, Director for Human Capital and Institutional Development at AUDA-NEPAD, will set the tone for Africa’s united call for regulatory cooperation as a driver of innovation, investment and trade.
Over five plenary sessions and fifteen parallel discussions, SCoMRA VII will unpack how regulatory harmonisation can catalyse pharmaceutical manufacturing, attract private investment and position Africa as a global health player. Topics will include advancing the African Medicines Agency, harnessing artificial intelligence in regulation, pooled procurement and implementing international standards for convergence. Notable contributors include Dr Boitumelo Semete-Makokotlela, CEO of South Africa’s Health Products Regulatory Authority; Dr Emer Cooke, Executive Director of the European Medicines Agency; Mr Hiiti Sillo of the WHO; and Dr Sarah Adam from the International Federation of Pharmaceutical Manufacturers and Associations.
One of the most anticipated outcomes of SCoMRA VII is the launch of the College for African Regulatory Science Professionals (CARSP). This new initiative will strengthen human and institutional capacity in medical product regulation by developing a network of skilled professionals equipped with modern tools and scientific expertise. The college represents Africa’s investment in its own people.
The implications of SCoMRA extend well beyond public health because effective regulation is the bedrock of industrialisation, innovation and trade.
Without harmonised standards, African manufacturers face barriers in gaining approval for products in neighbouring markets, and this undermines the goals of the African Continental Free Trade Area (AfCFTA) as well as the Pharmaceutical Manufacturing Plan for Africa (PMPA). By aligning regulatory frameworks, the continent can unlock economies of scale, reduce duplication and build investor confidence. When a medicine approved in one African country is recognised across borders, patients gain faster access while governments save both time and resources.
Regulatory unity also strengthens Africa’s voice in global health governance. When the continent speaks with one voice on standards and safety, it commands greater influence in international trade and technology partnerships. Harmonised systems therefore enable Africa not only to participate in global supply chains but also to shape them.
SCoMRA VII is more than a conference; it is a continental movement that transforms health ambition into action. It is where political leadership meets technical capacity and where Africa’s health independence becomes tangible. The outcomes from Mombasa will define how the continent produces, regulates and trades its own health products. The decisions made at the conference will not only shape the future of African health systems but will also affirm the continent’s rightful place as an equal partner in global health governance.
(Chamdimba is the Head of the African Medicines Regulatory Harmonisation (AMRH) Programme at the African Union Development Agency (AUDA-NEPAD). Her views don't necessarily reflect those of the Sunday Tribune, Independent Newspapers or IOL)