Public Health and Professional Standards PS Mary Muthoni with Pharmaceutical Society of Kenya (PSK) President, Dr Wairimu Njuki on September 23, 2025. /MARY MUTHONI/X
Kenya has stepped up preparations for a crucial World Health Organization mission that will evaluate the country’s progress in strengthening its medicines regulatory system.
The mission will allow WHO experts to assess the measures taken by the Pharmacy and Poisons Board (PPB) in areas such as inspections, pharmacovigilance, digital systems, and inter-agency collaboration.
Kenya is working towards achieving Maturity Level 3, an international standard that recognises a national regulator as stable, well-functioning, and capable of ensuring medicines are consistently safe, effective and of assured quality.
Attaining this level would mark a significant milestone for Kenya, aligning its regulatory capacity with global benchmarks and secure global recognition for its drug oversight framework.
Principal Secretary for Public Health and Professional Standards, Mary Muthoni, on Wednesday hosted a WHO delegation led by Acting Representative in Kenya, Dr Adiele Onyeze, for discussions centred on the upcoming onsite evidence verification mission.
The talks with WHO came a day after the PS met with the Pharmaceutical Society of Kenya (PSK) President, Dr Wairimu Njuki, to reinforce the government’s collaboration with pharmacists.
“The Ministry of Health recognises the critical role of pharmacists in strengthening Kenya’s health system,” she said, describing them as frontline providers who are “essential to ensuring quality, safety, and accessibility of medicines and health services across the country.”
Muthoni added that the government would work closely with PSK to fast-track the implementation of the Quality Health Pharmaceutical Services and Pharmacy Practice Bills, strengthen regulatory standards, and operationalise the Bioequivalence Hub to support local pharmaceutical manufacturing.
“Through structured collaboration, we aim to recognise pharmacists as central actors in health system reforms, improve patient safety, and advance Kenya’s journey towards WHO Maturity Level 3 regulatory standards,” she noted.
The PS also highlighted plans to enhance workforce planning, standardise training and continuous professional development, and expand pharmacist leadership in health supply chains and public health programmes.
The meeting with WHO, also attended by PPB board chair Dr John Munyu, CEO Dr Fred Siyoi and senior Ministry of Health officials, underscored the importance of aligning regulatory and professional reforms to build a resilient health system.
If successful, Kenya would join a select group of African countries recognised by WHO as having attained advanced regulatory status, enhancing confidence in the country’s ability to monitor medicines and pharmaceuticals within its borders.
