NAIROBI, Kenya – Kenya has intensified preparations for a World Health Organization (WHO) mission that will evaluate the country’s capacity to regulate medicines, in what could mark a turning point for its pharmaceutical sector.
The assessment, to be carried out by WHO experts, will review the Pharmacy and Poisons Board’s (PPB) performance in critical areas including drug inspections, pharmacovigilance, digital tracking systems, and collaboration with other agencies.
Kenya is targeting Maturity Level 3 (ML3) status — an international benchmark that recognises a national regulator as well-functioning, stable, and capable of ensuring medicines are consistently safe, effective, and of assured quality. Fewer than a dozen African countries have reached this milestone.
On Wednesday, Principal Secretary for Public Health and Professional Standards, Mary Muthoni, hosted a WHO team led by Acting Representative in Kenya, Dr. Adiele Onyeze, to discuss the upcoming on-site evidence verification mission.
“This is a pivotal step in advancing Kenya’s journey to Maturity Level 3,” Muthoni said, stressing the government’s commitment to aligning regulatory systems with global standards.
The talks came just a day after Muthoni met with Pharmaceutical Society of Kenya (PSK) President Dr. Wairimu Njuki, where she underscored pharmacists’ role in strengthening the health system.
“The Ministry of Health recognises the critical role of pharmacists as frontline providers, essential to ensuring the quality, safety, and accessibility of medicines across the country,” she said.
The government, she added, is working with PSK to fast-track reforms, including the implementation of the Quality Health Pharmaceutical Services Bill and the Pharmacy Practice Bill, alongside operationalising the Bioequivalence Hub to boost local drug manufacturing.
Muthoni also outlined plans to expand pharmacist leadership in health supply chains, standardise training, and improve continuous professional development.
The WHO mission will be carried out with the participation of PPB Chair Dr. John Munyu, CEO Dr. Fred Siyoi, and senior Ministry of Health officials.
If successful, Kenya will secure global recognition for its medicines regulatory system — a development that could attract investment in local pharmaceutical production and strengthen public confidence in drug safety.
