Pre-Conference Industry Day of the 7th Biennial Scientific Conference on the Regulation of Medical Products in Africa (SCoMRA VII) held in Mombasa. Photo/Courtesy
By Daisy Okiring
NAIROBI, Kenya: Kenya has taken a major step toward transforming its pharmaceutical landscape through a new collaboration with the Africa Medicines Agency (AMA). The partnership aims to speed up the registration and approval of essential medicines while strengthening local drug manufacturing.
The partnership was announced during the Pre-Conference Industry Day of the 7th Biennial Scientific Conference on the Regulation of Medical Products in Africa (SCoMRA VII) held in Mombasa. The event brought together regulators, policymakers, manufacturers, researchers, and development partners from across the continent to discuss innovative approaches to improve access to safe and effective medical products.
Speaking at the forum, Pharmacy and Poisons Board Acting CEO Ahmed Mohamed said the collaboration is designed to enhance Kenya’s regulatory efficiency and reduce long-standing delays in the availability of life-saving drugs.
“We intend to cooperate with the Africa Medicines Agency to fast-track the registration of pharmaceutical products so that we can make them available on the market sooner for the benefit of the public,” Ahmed stated.
He explained that the initiative will not only ensure timely access to essential medicines but also align Kenya’s regulatory systems with continental standards.
Harmonising regulations across Africa
Ahmed highlighted that the Pharmacy and Poisons Board has already begun harmonising pharmaceutical documentation to align with regional and continental requirements, calling it a crucial step toward ensuring efficiency, transparency, and collaboration across African health agencies.
The partnership comes at a time when African countries are increasingly working to establish stronger regulatory networks through the African Union’s health sovereignty agenda, which seeks to reduce reliance on imported drugs and enhance local production.
Africa Medicines Agency Director-General Delese Mimi Darko, who also addressed the Mombasa conference, reaffirmed the agency’s commitment to supporting African countries in building sustainable pharmaceutical industries.
Read More: Kenya’s healthcare sector on the brink of a nationwide drug shortage
“Increasing local production of medical products across Africa will not only improve access to safe, high-quality medicines but also reduce dependence on imports and promote industrial growth,” Darko said.
The Mombasa meeting, themed “Strengthening regulatory systems for access to quality, safe, and efficacious medical products in Africa,” runs throughout the week and serves as a platform for African regulators to share progress and challenges in advancing public health sovereignty through improved regulatory frameworks.
Kenya targets WHO maturity level 3 status
Meanwhile, Health Cabinet Secretary Aden Duale reiterated the government’s determination to attain World Health Organization (WHO) Maturity Level 3 (ML3) status in medical product regulation — a globally recognised benchmark that confirms a country’s ability to ensure the safety, efficacy, and quality of its health products.
“Achieving ML3 status is critical for enhancing access to quality-assured medicines, strengthening local pharmaceutical manufacturing, and improving pandemic preparedness,” Duale said during a high-level meeting with the National Quality Control Laboratory (NQCL) Board and senior management in Nairobi.
He added that the move will boost public confidence in Kenya’s healthcare system and support the nation’s broader vision of achieving universal health coverage.
Read More: Over 160 newborns, 14 mothers die during Kiambu doctors’ strike — CS Duale
Strengthening local capacity
Duale’s address followed an inspection tour of the NQCL facilities, where he emphasised the urgency of fast-tracking the repair and calibration of six stalled High-Performance Liquid Chromatography (HPLC) machines. The machines are vital for drug testing and certification, and their operationalisation is expected to enhance the laboratory’s efficiency and boost revenue generation.
He also revealed that the ministry had developed sustainable strategies to address institutional challenges that have affected the agency’s performance.
“Reducing turnaround time to the mandated 42 days will significantly improve client confidence and institutional credibility,” Duale noted, urging staff to uphold integrity, transparency, and accountability in all operations.
The Health CS further announced a 90-day action plan to ensure Kenya meets all prerequisites for WHO accreditation, noting that the country’s progress in regulatory reforms demonstrates its readiness to join the ranks of nations with trusted, self-reliant pharmaceutical systems.
“Kenya must take its rightful place among countries with reliable regulatory systems that protect citizens while encouraging innovation and industrial growth,” he said.
Toward a health-secure future
The partnership between Kenya and the Africa Medicines Agency represents a significant stride toward a self-sustaining pharmaceutical ecosystem in Africa. By harmonising drug registration processes and improving regulatory efficiency, Kenya aims to shorten approval timelines, strengthen quality assurance, and promote investment in local drug manufacturing.
Experts believe that if effectively implemented, the initiative could position Kenya as a regional hub for pharmaceutical production and regulation, driving down medicine costs while ensuring timely access to quality-assured products for millions of patients.
As the SCoMRA VII conference continues in Mombasa, stakeholders across the continent are optimistic that such collaborations will accelerate Africa’s journey toward health independence — where safe, effective, and affordable medicines are available to all who need them.
About the Author
