Kenya Champions Regulatory Harmonization to Boost African Health Product Access

Kenya's Pharmacy and Poisons Board Chairperson Dr. John Munyu and Health Cabinet Secretary Aden Duale have called for African regulators to harmonize health product regulations, emphasizing the need to boost local manufacturing and reduce reliance on imports.

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Nyakundi Report

Newsroom 2 min read

Primary source KBC

Kenya's Pharmacy and Poisons Board (PPB) Chairperson Dr. John Munyu has called on African regulators to harmonize health product regulations, stressing the importance of collaborative frameworks to improve access to essential medicines. Speaking at the closing of the 6th PharmaReg & MedDevReg AfriSummit in Nairobi on Friday, Munyu highlighted the need for regulatory alignment, support for local manufacturing, and stronger markets for African-made health products. He urged delegates to translate the summit’s discussions into actionable policies, regulatory reforms, and sustained partnerships, emphasizing that dependable systems are critical to ensuring public health and timely access to safe, effective, and affordable products.

Health Cabinet Secretary Aden Duale echoed Munyu’s call, stating that Africa’s pharmaceutical future hinges on regional cooperation. Duale noted that the continent imports over 70% of its health products, creating supply chain vulnerabilities that must be addressed through expanded local production. He outlined Kenya’s 2026–2030 Health Products and Technologies Local Manufacturing Strategy, which aims to achieve 50% local production of essential health products. The strategy includes 13 new pharmaceutical companies now operational in Kenya, some of which have begun exporting products, alongside efforts to strengthen safety and traceability systems for health products in the market.

The AfriSummit, attended by regulators, policymakers, manufacturers, and development partners, focused on addressing challenges in health product regulation across Africa. Delegates reviewed opportunities, practical approaches, and shared experiences from diverse regulatory environments. Munyu emphasized that the summit’s impact would depend on how effectively participants implement its recommendations, urging them to prioritize patient-centered systems and regulatory efficiency. Duale also reiterated Kenya’s commitment to advancing to World Health Organization (WHO) Maturity Level 3, which involves robust regulatory frameworks for health products.

The push for harmonization aligns with broader efforts to reduce Africa’s dependence on foreign pharmaceuticals and build resilient health systems. By fostering regional collaboration and local production, stakeholders aim to enhance access to critical health technologies while ensuring quality control. The summit’s conclusions underscore the urgency of translating dialogue into concrete actions, with Kenya positioning itself as a leader in driving Africa’s pharmaceutical self-reliance through policy innovation and strategic partnerships.

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