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Kenya accelerates drive for coveted WHO health product regulation certification

Health Cabinet Secretary Aden Duale reaffirms Kenya’s commitment to achieving WHO Maturity Level 3 (ML3) status, boosting medical product safety, local pharmaceutical growth, and Universal Health Coverage.

NAIROBI, Kenya, Nov 10 – Health Cabinet Secretary Aden Duale has reaffirmed the government’s commitment to achieving World Health Organization (WHO) Maturity Level 3 (ML3) status for health product regulation, a milestone that will significantly strengthen Kenya’s capacity to ensure the quality, safety, and efficacy of medical products.

Speaking during a high-level strategic meeting with the National Quality Control Laboratory (NQCL) Board and senior management at the institution’s Nairobi headquarters, CS Duale said attaining WHO ML3 status would place Kenya among countries with stable and internationally recognized 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 CS 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 realizing Universal Health Coverage (UHC).”

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

Client confidence

During an inspection of the NQCL facility, the CS highlighted the urgent need to fast-track the calibration, repair, and maintenance of six stalled HPLC machines to accelerate full operationalization of the laboratory, improve 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,” Duale noted.

“Reducing turnaround time to the mandated 42 days will improve client confidence and institutional credibility.”

He commended the institution’s steady progress and announced a focused 90-day sprint to meet 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 emphasized.

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.

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

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