Kenya Advances Toward WHO Recognition With Stronger Medicines Regulation

Kenya has taken another significant step in strengthening its health systems, with the Principal Secretary for Public Health and Professional Standards, Ms. Mary Muthoni, hosting a high-level delegation from the World Health Organization (WHO) today. The delegation was led by Dr. Adiele Onyeze, Acting WHO Representative in Kenya, and focused on the country’s progress in building a robust and internationally recognized medicines regulatory framework.

Focus on Strengthening Kenya’s Regulatory System

Central to the discussions was Kenya’s preparation for the upcoming WHO onsite evidence verification mission, a process through which WHO experts will assess the progress made by the Pharmacy and Poisons Board (PPB) in advancing its regulatory functions. The mission is a critical step in Kenya’s journey to attain WHO Maturity Level 3 (ML3) — an internationally recognized standard that certifies a country’s national medicines regulator as stable, well-functioning, and capable of ensuring medicines are consistently safe, effective, and of assured quality.

Maturity Level 3 status is a milestone that only a select number of African countries have achieved. For Kenya, it represents not only global recognition of its pharmaceutical regulatory system but also enhanced confidence in its ability to safeguard public health and attract investment in local pharmaceutical manufacturing.

Key Areas of Progress

The WHO mission will review Kenya’s achievements in several priority areas, including:

• Enhanced inspections of pharmaceutical facilities to ensure compliance with international standards.

• Pharmacovigilance systems to monitor, detect, and respond to adverse drug reactions and safety concerns.

• Digital transformation of regulatory processes for efficiency and transparency.

• Inter-agency collaboration, ensuring that the PPB works seamlessly with other government bodies and development partners to create an integrated and effective regulatory ecosystem.

Government Commitment to Stronger Regulation

PS Mary Muthoni underscored the government’s commitment to ensuring the PPB has the technical resources, infrastructure, and capacity building required to perform its role effectively. She noted that strengthening the regulator is not only about meeting global benchmarks but also about protecting Kenyans from unsafe and substandard medicines.

“Our commitment is to ensure that the Pharmacy and Poisons Board continues to grow into a world-class regulator. By equipping the board with modern tools, skilled personnel, and collaborative support, we are safeguarding the health of our citizens while positioning Kenya as a regional leader in pharmaceutical regulation,” Ms. Muthoni said.

Stakeholder Participation

The meeting was attended by key stakeholders in the health sector, including PPB Board Chair, Dr. John Munyu, CEO Dr. Fred Siyoi, and other senior ministry officials. Their presence underscored the importance of this mission, as Kenya’s progress toward ML3 status requires strong collaboration between the Ministry of Health, the PPB, and development partners like WHO.

Pathway to Global Recognition

Achieving Maturity Level 3 would signal that Kenya’s regulatory system is operating at a high standard of quality and reliability. This recognition would open opportunities for Kenya to participate in global regulatory reliance systems, meaning other countries and international organizations could trust Kenya’s assessments of medicine quality. Such recognition would also support Kenya’s ambition to become a regional pharmaceutical manufacturing hub, driving local production and reducing dependence on imported medicines.

Looking Ahead

As Kenya prepares for the WHO verification mission, the country is demonstrating not just progress in regulatory oversight but also a vision for sustainable health systems that protect citizens and align with global best practices. The upcoming mission is more than a technical exercise — it is a gateway to international confidence in Kenya’s health sector and a vital step towards improving access to safe, effective, and affordable medicines for all.