Kenya: Health Cabinet Secretary (CS) Reaffirms Government’s Commitment to Attaining World Health Organization (WHO) Maturity Level 3 for Health Product Regulation

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Ministry of Health, Kenya

Health Cabinet Secretary Hon. Aden Duale has reaffirmed the Government’s commitment to achieving World Health Organization (WHO) Maturity Level 3 (ML3) status for health product regulation, marking a major step toward strengthening Kenya’s capacity to ensure the quality, safety, and efficacy of all medical products.

Speaking during a high-level strategic meeting with the National Quality Control Laboratory (NQCL) Board and senior management at the institution’s headquarters in Nairobi, the CS said the attainment of WHO ML3 status will position Kenya among countries with stable and internationally recognised regulatory systems for medical products.

“This milestone is critical for enhancing access to quality-assured medicines, strengthening local pharmaceutical manufacturing, and reinforcing pandemic preparedness,” said Hon. Duale. “It will also build public confidence by guaranteeing that health products in Kenya are consistently safe, effective, and of the highest quality — a key pillar in realising Universal Health Coverage (UHC).”

The engagement followed an earlier meeting with the NQCL Board at the Ministry, where longstanding institutional challenges were reviewed and sustainable strategies developed to strengthen operational capacity and improve overall performance.

During an inspection of the facility, the CS highlighted the urgent need to fast-track the calibration, repair, and maintenance of six stalled HPLC machines to accelerate full operationalisation of the laboratory, enhance efficiency, and boost revenue generation.

“I have urged the NQCL Board and staff to uphold the highest standards of integrity, transparency, and accountability, while aligning operations with modern healthcare demands,” Hon. Duale noted. “Reducing turnaround time to the mandated 42 days will improve client confidence and institutional credibility.”

He further commended the institution’s steady progress and announced a 90-day sprint focused on meeting all prerequisites for attaining WHO ML3 accreditation.

“Kenya must take its place among nations with trusted regulatory systems that not only protect citizens but also promote innovation and industrial growth,” the CS emphasised.

The meeting also included an interactive session with NQCL staff to discuss strategies for fostering a supportive work environment that enhances productivity and service delivery.

The CS was hosted by NQCL Board Chairperson Dr John Muturi and CEO Dr Sultani Matendechero, and accompanied by Principal Secretary for Public Health and Professional Standards Ms Mary Muthoni and Director General for Health Dr Patrick Amoth.

Distributed by APO Group on behalf of Ministry of Health, Kenya.

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