Kenya is ramping up efforts to attain the World Health Organization's (WHO) Maturity Level 3 (ML3) status in pharmaceutical regulation by December this year.
This is a milestone expected to strengthen oversight of medical products, boost local manufacturing, and improve access to safe and effective medicines.
The Ministry of Health, through the Pharmacy and Poisons Board (PPB), is leading reforms aimed at elevating the country's regulatory system from its current Maturity Level 2 (ML2) ranking to the internationally recognised ML3 standard.
Achieving ML3 status would place Kenya among a select group of African nations with stable and well-functioning regulatory systems capable of ensuring the quality, safety and efficacy of medicines and other health products.
The designation is also expected to attract investment, enhance public confidence in healthcare systems, support pharmaceutical innovation, and open new export opportunities for local manufacturers.
Under the WHO's global benchmarking tool, national regulatory systems are assessed on a four-tier scale, and Kenya is now pushing to attain the third level.
While ML1 reflects the existence of basic regulatory elements and ML2 denotes an evolving system, ML3 signifies a stable and integrated framework capable of effectively performing essential regulatory functions.
ML4, the highest level, represents advanced systems committed to continuous improvement.
Currently, only nine African countries—Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, Rwanda, and Ethiopia—have achieved ML3 status. No country on the continent has reached ML4.
Speaking at the 46th Pharmaceutical Society of Kenya (PSK) annual scientific conference in Mombasa, Health Cabinet Secretary Mr Aden Duale said Kenya remains firmly on course to achieve the milestone within the next 18 months.
Duale described the target as more than a regulatory achievement, saying it forms part of the country's broader strategy to strengthen healthcare systems and position Kenya as a leading pharmaceutical hub in Africa.
“This milestone is not merely a regulatory achievement; it is a strategic national objective that will strengthen confidence in Kenya's regulatory systems, accelerate local innovation, facilitate regional and global market access, and position Kenya as a pharmaceutical manufacturing and regulatory hub for Africa,” he said.
He underscored the need to protect professional standards within the pharmaceutical sector and pledged continued support for reforms aimed at enhancing accountability and eliminating illegal practice.
He said the government would continue strengthening regulatory frameworks to combat quackery, enforce professional standards, and ensure that only qualified and licensed personnel provide pharmaceutical services.
“We must ensure that fake, substandard and falsified medicines have absolutely no place within our supply chains. We must also ensure that unqualified persons do not masquerade as healthcare professionals and place lives at risk. Patient safety must always remain non-negotiable,” Duale said.
He noted that lessons from the COVID-19 pandemic highlighted the dangers of overdependence on imported medicines and medical technologies, reinforcing the need for stronger domestic production capacity.
“Health sovereignty requires local resilience. Kenya cannot afford to remain primarily an importer of medicines and health technologies. We must become a producer, innovator and exporter,” he said.
To support that vision, the Ministry recently unveiled the Health Products and Technologies Local Manufacturing Strategy, a blueprint designed to strengthen domestic production of medicines, vaccines, biotherapeutics and medical devices.
The strategy aims to support more than 30 manufacturers, enabling them to compete in regional and international markets while reducing import dependence, creating jobs, stimulating research and innovation, and securing sustainable access to essential health products.
In a further push to modernise pharmaceutical regulation, the Ministry of Health, the Pharmacy and Poisons Board and the Digital Health Agency will roll out three national digital platforms across the sector from July 1, 2026.
The platforms—National Track and Trace System, Practice 360 and Facility 360—are expected to improve pharmaceutical governance, enhance patient safety, strengthen supply chain visibility, and curb the circulation of counterfeit medicines.
Under the directive, pharmacists, pharmaceutical technologists, manufacturers, importers, distributors, wholesalers, pharmacies, chemists and healthcare facilities handling pharmaceutical products will be required to register, integrate and maintain compliance with the digital systems.
Industry players will also be required to adopt GS1 global standards for product identification, serialisation, authentication and traceability, while reporting pharmaceutical transactions through the National Logistics Management Information System and the National Track and Trace System.
The reforms further require full interoperability with national digital health systems and the maintenance of accurate electronic records covering pharmaceutical inventory, distribution, dispensing and utilisation.
PSK president Dr Wairimu Njuki said Kenya possesses significant potential to expand local pharmaceutical manufacturing but requires a supportive environment that enables firms to grow and remain competitive.
She reaffirmed the society's commitment to supporting policies that strengthen domestic production, attract investment, create employment opportunities, and improve access to affordable, quality medicines.
“As a Society, we strongly support Kenya's journey towards attaining WHO GBT Maturity Level 3 and beyond.
"This achievement is not simply a regulatory milestone. It is a national statement that Kenya is committed to ensuring the quality, safety, and efficacy of medicines and health products available to its citizens,” she said.
PPB chairman Dr John Munyu called on pharmaceutical professionals to embrace self-regulation and collaborate closely with the board in rooting out unqualified practitioners from the sector.
