Kenya is intensifying efforts to attain the World Health Organization (WHO) Global Benchmarking Tool (GBT) Maturity Level 3 (ML3) status by December 2026, a milestone expected to strengthen pharmaceutical regulation, improve the quality and safety of medical products, boost local manufacturing, and enhance access to essential medicines and vaccines.
The Ministry of Health, through the Pharmacy and Poisons Board (PPB), is leading a series of reforms aimed at achieving the globally recognized regulatory standard and positioning Kenya among a select group of African countries with advanced medical product regulatory systems.
Achieving ML3 status demonstrates a country’s ability to effectively regulate medical products and ensure their safety, quality, and efficacy. It also strengthens healthcare systems, attracts investment, supports pharmaceutical innovation, and facilitates access to regional and international markets.
The WHO assesses national regulatory systems using its Global Benchmarking Tool, which ranks countries on a scale from Maturity Level 1 to Maturity Level 4. Kenya currently holds ML2 status, which indicates an evolving regulatory system capable of performing some essential functions. ML3 signifies a stable, well-functioning, and integrated regulatory framework, while ML4 represents a highly advanced system characterized by continuous improvement and innovation.
To date, only nine African countries have attained ML3 status: Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, Rwanda, and Ethiopia. No African country has yet achieved ML4 status.
Speaking during the 46th Pharmaceutical Society of Kenya (PSK) Annual Scientific Conference in Mombasa, Health Cabinet Secretary Aden Duale said Kenya remains firmly on course to attain ML3 status by December 2026.
Duale emphasized that attaining the milestone will require sustained commitment to professional standards and adherence to clearly defined scopes of practice within the healthcare sector.
He pledged continued government support for regulatory reforms aimed at strengthening professionalism, enforcing standards, eliminating quackery, and ensuring that only qualified and licensed professionals perform duties assigned to them under the law.
According to the Cabinet Secretary, strengthening the Pharmacy and Poisons Board remains critical in safeguarding the integrity of Kenya’s pharmaceutical sector and protecting public health.
“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,” he said.
Duale reaffirmed the Ministry’s commitment to supporting the PPB’s efforts to achieve WHO ML3 status, describing the target as more than a regulatory accomplishment.
“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.
The Cabinet Secretary noted that disruptions experienced during the COVID-19 pandemic exposed vulnerabilities associated with excessive reliance on imported medicines and health technologies.
“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 address these challenges, the Ministry recently launched the Health Products and Technologies Local Manufacturing Strategy, a comprehensive roadmap intended to support more than 30 pharmaceutical, vaccine, biotherapeutic and medical device manufacturers.
The strategy aims to reduce dependence on imported health products, create employment opportunities, stimulate research and innovation, strengthen industrial capacity, and guarantee sustainable access to essential medicines.
Duale said the initiative is expected to enhance Kenya’s competitiveness within regional and international pharmaceutical markets while contributing to national health security.
As part of broader efforts to strengthen pharmaceutical governance and patient safety, the Ministry of Health, the Pharmacy and Poisons Board, and the Digital Health Agency (DHA) will roll out three national digital platforms across the pharmaceutical sector effective July 1, 2026.
The platforms include the National Track and Trace System, Practice 360, and Facility 360.
According to the Cabinet Secretary, the digital systems are designed to improve supply chain visibility, combat counterfeit medicines, enhance accountability, and ensure compliance with national health regulations.
“Effective July 1, 2026, all pharmacists, pharmaceutical technologists, pharmacies, chemists, manufacturers, importers, distributors, wholesalers and healthcare facilities handling pharmaceutical products shall be required to register, integrate and maintain active compliance with these platforms,” he directed.
In addition, all pharmaceutical manufacturers, importers, distributors, wholesalers, pharmacies, chemists and healthcare facilities will be required to comply with GS1 Global Standards governing product identification, serialization, authentication and traceability.
They will also be expected to capture and report all pharmaceutical products and transactions through the National Logistics Management Information System (LMIS) and the National Track and Trace System (NTTS).
The facilities must further ensure interoperability with national digital health systems and standards prescribed by the Digital Health Agency and maintain accurate and timely electronic records on pharmaceutical inventory, distribution, dispensing and utilization.
The government believes the adoption of these digital tools will significantly strengthen oversight of pharmaceutical products throughout the supply chain while minimizing opportunities for counterfeit and substandard medicines to enter the market.
Pharmaceutical Society of Kenya President Dr. Wairimu Njuki welcomed the reforms and said Kenya possesses enormous potential to expand local pharmaceutical manufacturing if provided with the right policy and regulatory environment.
She noted that local manufacturers require a supportive ecosystem that enables them to grow, compete effectively, attract investment, and contribute meaningfully to national medicine security.
Njuki affirmed the society’s commitment to supporting policies that strengthen pharmaceutical manufacturing, create jobs, stimulate innovation, and improve access to affordable, high-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 Chairperson Dr. John Munyu called on pharmaceutical professionals to embrace self-regulation and collaborate closely with the board in efforts to eliminate unqualified practitioners from the sector.
He urged members of the Pharmaceutical Society of Kenya to uphold professional ethics and support initiatives aimed at strengthening public confidence in the profession.
by Sadik Hassan
