By Morara Kebaso
The hosting of the Seventh Biennial Scientific Conference on Medical Products Regulation (SCoMRA VII) by Kenya is timely for a country working round the clock to stem the menace of unregulated medicine in the local market, in the words of Dr. Ahmed I. Mohamed, the Acting Chief Executive Officer of the Pharmacy and Poisons Board (PPB).
In April this year, the Board revealed that in recent years, the country has recorded increased product recalls, that are still frequent today.
In 2024, the national drug regulator made a total of 32 recalls. And in 2023, there were 18 health product recalls reported in the country by the PPB.
Despite recent developments where a joint operation between Kenya and Uganda under Operation African Star – uncovered a network of illicit medical products including human medicines, biologic products and dietary supplements – Dr. Mohamed feels that medical product regulation in Kenya needs to become faster, more collaborative, and standardized to improve patient access to quality medicines. Operation African Star is aimed at improving health and disrupting the illicit trade in health products, pharmaceutical preparations, medical devices, and equipment across Africa.
“SCoMRA VII provides a unique platform to assess progress in regulatory systems strengthening, explore how the emerging African Medicines Agency (AMA) can accelerate access to quality-assured medical products, and advance Africa’s health security through enhanced local manufacturing and trade under the African Continental Free Trade Area (AfCFTA),” he noted before the SCoMRA VII kicked off early Tuesday in Mombasa.
The three-day meeting Novemeber 11-13, 2025 is themed: “Regulatory Harmonisation:Unlocking Africa’s Potential in Health Product Manufacturing and Trade”
Since he ws appointed as acting CEO of the Board, Dr. Ahamed is focused on strengthening Kenya’s regulatory capacity by collaborating with the AMA, enforcing strict oversight, and aligning with continental standards to reduce approval timelines and combat substandard products.
While addressing delegates on Tuesday, the Board’s Chairperson, Dr John Munyu, has urged African countries to accelerate regulatory harmonisation and collaboration to unlock the continent’s potential in local health product manufacturing and trade.
He said the conference theme reflects a shared ambition for a stronger, self-reliant, and resilient Africa.
“Africa imports over 90 percent of its medicines and produces less than one percent of its vaccines. This is not just a statistic — it is a reminder of our dependence and vulnerability, which the COVID-19 pandemic painfully exposed,” Dr Munyu said.
Recent health emergencies such as the Monkeypox outbreak, which was declared a continental public health emergency by the Africa CDC in 2024, he noted, have demonstrated the urgent need for coordinated and responsive regulatory systems.
Dr Munyu highlighted that the African Medicines Regulatory Harmonisation (AMRH) programme has laid a strong foundation for progress over the past decade, through harmonised regulatory frameworks and the digitalisation of processes across regional blocs. This progress, he said, has culminated in the establishment of the African Medicines Agency (AMA), headquartered in Kigali, which represents a new era of collaboration and accountability.
“The AMA embodies Africa’s vision of self-reliance and resilience. SCoMRA VII offers a strategic platform to translate this vision into tangible action — to catalyse local manufacturing, promote intra-African trade under the AfCFTA, and ensure that quality, safe, and efficacious medical products reach every African,” he added.
The PPB Chair applauded the leadership of Dr Mimi Darko, the first Director-General of AMA, who will deliver her inaugural address during the conference, assuring her of Kenya’s and Africa’s full support in ensuring AMA’s success.
Dr Munyu further outlined the focus areas for the three-day conference, including strengthening regulatory oversight to attract and sustain local manufacturing investments, advancing pooled procurement mechanisms, leveraging artificial intelligence and digitalisation to modernise regulatory ecosystems, and deepening partnerships across public, private, and research institutions.
“The delegates gathered here — regulators, policymakers, manufacturers, and partners — are the architects of a new regulatory future for Africa. Let us move from dialogue to decisive action and leave Mombasa with a clear, actionable roadmap,” he urged.
He expressed appreciation to partners including the World Health Organization (WHO), Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, German Cooperation (GIZ), and the Africa Public Health Foundation for their support in advancing Africa’s regulatory agenda.
Dr Munyu reaffirmed the PPB’s continued commitment to strengthening national, regional, and continental regulatory systems through reliance, collaboration, and innovation.
“Our objectives are clear, our potential immense, and our collective resolve remains key to unlocking it,” he said, setting the tone for the high-level deliberations ahead of the conference’s official opening by the cabinet Secretary for health on 12 November.
The conference is graced by policymakers, regulators, researchers, the academia, manufacturers, and development partners from across Africa and globally to discuss advances in regulatory science and reflect on Africa’s progress in strengthening and harmonising medical product regulation. This is aimed at advancing Africa’s Health Product Ecosystem.
The meeting is featuring plenary and parallel sessions covering topics such as; strengthening harmonised regulatory oversight and leveraging local manufacturing, the role of AMA and regional initiatives in advancing pooled procurement and intra-African trade; digitalisation, innovation, and Artificial Intelligence in regulatory systems among others.
Participants will also cover areas such as, emergency preparedness and regulation of medical devices and diagnostics; including greening Africa’s pharmaceutical manufacturing ecosystem.
Those attending are also drawn from the National Medicines Regulatory Authorities (NMRAs), African Union agencies, Regional Economic Communities (RECs), academic institutions, researchers, civil society organizations, the private sector, and international partners.
The expected outcomes from the meeting include; strengthening collaboration among regulatory authorities and stakeholders; define strategic actions to support local manufacturing and pooled procurement; promote innovation and digital transformation in regulatory systems; and shape a shared vision for the future of medical products regulation in Africa under AMA.
