Kenya is working to improve public health, increase access to quality medical products and strengthen regulatory oversight as part of its goal to achieve World Health Organisation (WHO) Maturity Level 3 (ML3) for its health regulatory system.
Though the country has not officially achieved ML3 status, it has made progress and is currently at Maturity Level 2, indicating that its regulatory system is evolving and has many foundational elements in place.
The Pharmacy and Poisons Board (PPB), the Ministry of Health and other stakeholders, is leading reforms to align Kenya's regulatory framework with international norms.
Achieving ML3 would mean that the country's regulatory authority has established a stable, efficient and integrated system capable of ensuring the quality, safety and efficacy of medical products in accordance with international best practice.
What are the key criteria used by WHO to assess and assign maturity levels?
WHO uses the Global Benchmarking Tool (GBT) to assess national regulatory systems based on more than 260 indicators.
These are grouped into nine core functions, including product registration, pharmacovigilance, inspections, laboratory testing, clinical trial oversight and post-marketing surveillance.
How many levels of maturity are there, and how does Level 3 differ from the others?
The WHO classifies regulatory systems into four levels: Level 1 indicates the existence of some basic structures; Level 2 indicates developing systems; Level 3 indicates that the system is functional and well established; and Level 4 reflects a highly advanced system that is continuously improving and adapting to innovation.
Maturity level 3 is the key benchmark for global recognition - it demonstrates that a country has established a reliable system that can independently regulate its medical devices.
How long has Kenya been working towards this level and what are the key milestones?
Kenya has been working towards this goal for almost a decade, investing in reforms and infrastructure and aligning its systems with WHO standards. Several institutional reforms have already been implemented to help the country achieve compliance.
For example, Kenya has developed a quality management system, improved post-marketing surveillance and a created digital licensing platforms and implemented the Integrated Regulatory Information Management System.
What health products or sectors has Kenya covered in its assessment?
The assessment covers a wide range of product categories, including human and veterinary medicines, vaccines, diagnostics, and other medical technologies. In addition, efforts are being made to cover the National Quality Control Laboratories (NQCL).
What challenges have hindered progress?
Despite recent improvements, Kenya continues to face several challenges that have prevented it from officially achieving maturity level 3.
A major obstacle is the existence of an outdated legal framework that limits the enforcement of modern regulatory practices. Financial constraints have also delayed the upgrading of laboratories and information systems. In addition, the country is grappling with incomplete integration of digital data systems and is struggling to keep up with the rapid growth of local pharmaceutical manufacturing.
What does reaching maturity Level 3 say about Kenya's health regulatory system?
Achieving ML3 would result in faster access to safe and effective medical products, improved local oversight of pharmaceutical manufacturing, and enhanced capacity to respond to public health emergencies.
It would also give Kenya greater autonomy in regulatory decisions, reducing reliance on foreign approvals for vaccines, diagnostics and medicines.
"The NQCL plays a critical role in ensuring the quality, safety and efficacy of healthcare products for all Kenyans. As a government, we are committed to addressing its challenges and providing the necessary support to ensure that it effectively fulfils its mandate," said Mary Muthoni, Principal Secretary, Public Health.
What are the practical implications of Maturity Level 3 for Kenya's health system?
A functioning Maturity Level 3 (ML3) regulatory authority improves access to medicines by speeding up approvals and ensuring that only safe and effective products are available on the market.
 his approach builds public confidence and protects patients from harmful, substandard or counterfeit products.
The agency strengthens Kenya's ability to enforce standards, conduct thorough inspections and respond quickly to defective products. It also supports the government's UHC goals by ensuring a consistent supply of essential medicines.
What does this mean for Kenya's role in the African and global pharmaceutical landscape?
Achieving ML3 would enhance Kenya's position as a leader in the East Africa. It would also enable Kenya to participate in joint product reviews, share inspection reports and enter into mutual recognition agreements, thereby reducing duplication of regulatory efforts.
Currently, eight African countries, including Egypt, South Africa, Tanzania, Nigeria, Ghana, Zimbabwe, Senegal and Rwanda, have achieved Level 3 maturity.
