Kenya Partners with Africa Medicines Agency to Accelerate Drug Registration and Boost Local Manufacturing
Key Insights
Kenya (search) has announced a partnership with the Africa Medicines Agency (search) to fast-track pharmaceutical product registration and reduce delays in accessing essential medicines.
The collaboration aims to harmonize pharmaceutical documentation with continental standards while strengthening Kenya (search)'s regulatory capacity for health product approval.
Kenya (search) is pursuing WHO Maturity Level 3 status for health product regulation to enhance access to quality medicines and support local pharmaceutical manufacturing.
Kenya (search) has announced a strategic partnership with the Africa Medicines Agency (search) (AMA) to accelerate pharmaceutical product registration and strengthen local manufacturing capabilities, marking a significant step toward improving access to essential medicines across the region.
The collaboration was unveiled during the Pre-Conference Industry Day of the 7th Biennial Scientific Conference on the Regulation of Medical Products in Africa (SCoMRA VII) in Mombasa, where Pharmacy and Poisons Board (search) (PPB) Acting CEO Ahmed Mohamed outlined the initiative's objectives.
"We intend to cooperate with the Africa Medicines Agency (search) to fast-track registration of pharmaceutical products so that we can have them on the market sooner for the benefit of the public," Mohamed stated. "This will ensure patients access vital products more efficiently."
Harmonizing Continental Standards
The partnership focuses on aligning Kenya (search)'s pharmaceutical regulatory framework with continental standards through documentation harmonization. Mohamed described this alignment as a crucial step toward enhancing efficiency, transparency, and regional collaboration in health product regulation.
Africa Medicines Agency (search) Director General Delese Mimi Darko emphasized AMA's commitment to supporting local pharmaceutical manufacturing across Africa. She noted that increased regional production will improve access to safe, affordable, and high-quality medical products while reducing dependence on imports.
Pursuing WHO Maturity Level 3 Status
Health Cabinet Secretary Aden Duale reaffirmed Kenya (search)'s commitment to achieving World Health Organisation (WHO) Maturity Level 3 (ML3) status for health product regulation—a major milestone that would significantly strengthen the country's capacity to ensure quality, safety, and efficacy of all medical products.
"This milestone is critical for enhancing access to quality-assured medicines, strengthening local pharmaceutical manufacturing and reinforcing pandemic preparedness," Duale said during a strategic meeting with the National Quality Control Laboratory (search) (NQCL) Board. "It will also build public confidence by guaranteeing that health products in Kenya (search) are consistently safe, effective, and of the highest quality, a key pillar in realising Universal Health Coverage (UHC)."
Laboratory Infrastructure Upgrades
The government has identified critical infrastructure needs at the National Quality Control Laboratory (search), including the urgent repair and maintenance of six stalled HPLC machines. These upgrades are essential for accelerating full operationalization of the laboratory and enhancing efficiency.
Duale emphasized the importance of reducing turnaround times to the mandated 42 days to improve client confidence and institutional credibility. "I have urged the NQCL Board and staff to uphold the highest standards of integrity, transparency, and accountability, while aligning operations with modern healthcare demands," he stated.
90-Day Implementation Sprint
The Health Cabinet Secretary announced a focused 90-day sprint to meet all prerequisites for attaining WHO ML3 accreditation. This accelerated timeline reflects the government's urgency in strengthening Kenya (search)'s regulatory systems.
"Kenya (search) must take its place among nations with trusted regulatory systems that not only protect citizens but also promote innovation and industrial growth," Duale added.
The SCoMRA VII conference continues under the theme "Strengthening Regulatory Systems for Access to Quality, Safe, and Efficacious Medical Products in Africa," bringing together regulators, policymakers, manufacturers, researchers, and development partners to discuss innovative approaches for harmonizing medical product regulation across the continent.