Kenya is intensifying efforts to achieve World Health Organization (WHO) Maturity Level 3 status for its medicines regulatory system, a critical milestone expected to strengthen pharmaceutical oversight, enable exports, and unlock local manufacturing potential.
Dr Ouma Oluga Permanent Secretary Medical Services Ministry of Health said that the move is central to building a resilient, trusted, and globally competitive health products ecosystem, as the country positions itself as a regional pharmaceutical hub.
“Maturity Level 3 is not just a technical assessment it is the foundation of credibility for our regulatory system,” Dr Olga said. “Without it, you cannot export medicines, attract serious investment, or sustain local manufacturing.”
What WHO Maturity Level 3 Means
WHO’s Global Benchmarking Tool (GBT) assesses national regulatory authorities across several functions, including marketing authorisation, pharmacovigilance, inspections, laboratory testing, and clinical trial oversight.
According to Dr John Munyu, Board Chairman Pharmacy and Poisons Board achieving Maturity Level 3 signifies that a country has a stable, well-functioning, and integrated regulatory system capable of ensuring the quality, safety, and efficacy of medical products across their entire life cycle.
He explained that for Kenya the status would allow locally manufactured pharmaceutical products to be recognized internationally, opening doors to regional and global markets.
Dr Oluga said that to fast-track the journey to Maturity Level 3, the government will invest heavily in regulatory capacity enhancement, particularly within the Pharmacy and Poisons Board (PPB).
“One of the key interventions includes the recruitment of 46 pharmacists as regulatory officers, supported through World Bank financing. These officers will strengthen inspections, market surveillance, and compliance monitoring across pharmaceutical manufacturing facilities,”Dr Oluga said.
“These pharmacists will not only inspect industries,” he said adding that, “They will help stabilise our regulatory environment, ensuring predictability and confidence for investors and manufacturers.”
Dr Munyu said that the additional regulatory enforcement officers will be deployed to support Good Manufacturing Practice (GMP) inspections, post-market surveillance, and regulatory decision-making areas considered critical gaps in previous assessments.
Dr Wairimu Mbogo, Pharmaceutical Society of Kenya President, said that the regulatory reforms will help Kenya’s broader push to scale up local pharmaceutical manufacturing.
She said that without a strong regulatory authority, locally produced medicines cannot be exported or procured by international agencies.
“Maturity Level 3 gives us export readiness,” She said adding that. “It assures the world that what is manufactured in Kenya meets international standards.”
The reforms are being implemented in collaboration with the Pharmaceutical Society of Kenya, the Federation of Kenya Manufacturers, and the Ministry of Trade and Investment and Ministry of Health ensuring alignment between regulation, industry growth, and workforce development.
Recent global supply disruptions including shortages of essential vaccines have underscored the need for regulatory autonomy and system resilience.
Kenya’s push toward regulatory maturity aims to reduce reliance on unpredictable global supply chains by enabling faster local approvals, consistent quality assurance, and reliable market surveillance.
“When global shortages occur, a mature regulator allows us to respond quickly without compromising safety,” Dr Munyu explained.
Dr Oluga also said that digitisation will play a key role in regulatory strengthening. The Ministry of Health is integrating regulatory data systems to ensure evidence-based, transparent, and reproducible decisions.
“We want a system where decisions are driven by data, not discretion,”He noted, “If another professional sat in my position, they would reach the same conclusion based on the same evidence.”
This digital approach supports regulatory traceability, post-market monitoring, and efficient oversightkey requirements under the WHO benchmarking framework.
Beyond infrastructure and systems, the reforms aim to create long-term career pathways for pharmacists in regulatory and industrial pharmacy—fields that have remained underdeveloped due to limited manufacturing capacity.
“Regulatory strengthening is also about job creation,” Oluga said. “We are unlocking a professional pathway that allows pharmacists to work beyond hospitals and retail pharmacies.Kenya Accelerates Push Toward WHO Maturity Level 3 to Strengthen Pharmaceutical Regulation.
