Kenya Fast-Tracks WHO ML3 Status to Boost Drug Safety and UHC Goals

“This milestone is critical for enhancing access to quality-assured medicines, strengthening local pharmaceutical manufacturing, and reinforcing pandemic preparedness,” said Hon. Duale.

In a bold move to enhance Kenya’s pharmaceutical regulatory capacity, 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. This globally recognised designation would signify that Kenya has developed a stable, well-functioning, and internationally trusted regulatory system for the oversight of medicines and medical products.

Speaking during a high-level strategic meeting at the National Quality Control Laboratory (NQCL) headquarters in Nairobi, Hon. Duale emphasised that WHO ML3 accreditation is more than a technical milestone — it’s a critical building block for ensuring access to safe and effective medical products, driving local pharmaceutical manufacturing, and advancing the Universal Health Coverage (UHC) agenda.

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Why WHO ML3 Status Matters for Kenya

The WHO Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels. Maturity Level 3 is considered the minimum standard for a functioning regulatory authority capable of ensuring the quality, safety, and efficacy of medical products on a continuous basis. Currently, only a handful of countries in Africa have reached ML3, including South Africa, Tanzania, Egypt, and more recently, Nigeria.

“This milestone is critical for enhancing access to quality-assured medicines, strengthening local pharmaceutical manufacturing, and reinforcing pandemic preparedness,” said Hon. Duale.

Achieving ML3 will place Kenya among leading nations with trusted regulatory systems, positioning the country to better control imports, support domestic manufacturers, and boost investor confidence in the healthcare sector. It will also enable Kenya to participate more robustly in international procurement, such as through WHO’s Prequalification Programme and global health financing platforms like the Global Fund and Gavi.

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Urgent Reforms at NQCL to Meet WHO Standards

The meeting followed an earlier strategic session between the Ministry and the NQCL Board, where longstanding institutional challenges were reviewed and solutions mapped out to strengthen operational performance and technical capacity.

Hon. Duale conducted an on-site inspection of the laboratory, where he identified several technical setbacks, including the non-operational status of six High-Performance Liquid Chromatography (HPLC) machines—essential tools for drug quality testing.

“There is an urgent need to fast-track the calibration, repair, and maintenance of stalled HPLC machines to accelerate full operationalisation of the laboratory,” he said.

The CS underscored that restoring full functionality would not only improve testing turnaround times but also boost NQCL’s revenue generation and ability to support national regulatory functions.

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Reducing Turnaround Times and Increasing Transparency

In line with WHO benchmarks, Hon. Duale directed the NQCL to reduce sample testing turnaround time to 42 days, the internationally accepted maximum for quality control labs. This efficiency target, he said, is vital for improving client satisfaction, public confidence, and the institution’s credibility.

He further urged the NQCL board and staff to embed values of integrity, transparency, and accountability into their daily operations.

“I have urged the NQCL Board and staff to uphold the highest standards while aligning operations with modern healthcare demands,” he noted.

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90-Day Sprint to WHO ML3 Readiness

The CS also announced a 90-day sprint aimed at fast-tracking the remaining steps needed for WHO ML3 accreditation. This includes:

• Completing infrastructure upgrades

• Enhancing human resource capacity and continuous professional development

• Strengthening documentation and quality assurance systems

• Ensuring consistent implementation of standard operating procedures

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

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Staff Engagement and a Culture of Performance

Beyond technical upgrades, the CS led an interactive session with NQCL staff, focusing on how to foster a supportive, productive, and accountable work culture. Staff were encouraged to share insights, identify bottlenecks, and propose solutions to improve service delivery.

This people-focused approach reflects the Ministry’s broader aim to transform public health institutions into high-performing entities, rooted in professionalism and citizen service.

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High-Level Stakeholder Support

The visit brought together key leadership figures in Kenya’s health ecosystem, including:

• Dr. John Muturi, Chairperson of the NQCL Board

• Dr. Sultani Matendechero, NQCL CEO

• Ms. Mary Muthoni, Principal Secretary for Public Health and Professional Standards

• Dr. Patrick Amoth, Director General for Health

Their joint presence underlines the multi-stakeholder backing for the ML3 accreditation drive and wider pharmaceutical sector reforms.

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A Boost for UHC, Manufacturing, and Pandemic Readiness

Kenya’s pursuit of WHO ML3 status is a strategic enabler of several national goals:

• Universal Health Coverage (UHC): Ensures that medicines in public and private sectors meet safety and efficacy standards

• Pharmaceutical self-reliance: Enhances the regulatory environment to support local manufacturing and reduce dependency on imports

• Pandemic preparedness: Provides a robust framework for the rapid approval, distribution, and monitoring of medical products in health emergencies

By aligning regulatory efforts with international best practices, Kenya is building resilience and trust in its healthcare system.