Pharmacy and Poisons Board inspectors conduct post-market surveillance to ensure health products meet required standards of quality, safety and efficacy. [Benard Orwongo, Standard]
Kenya is strengthening its medicines regulatory systems to ensure medical products entering the market are safe, effective and of assured quality.
Pharmacy and Poisons Board (PPB) Chairperson John Munyu said the country has made progress in strengthening laws, technical capacity, quality systems and regulatory processes, with a growing focus on consistent, predictable and risk-based regulation.
Speaking in Nairobi during the 6th PharmaReg and MedDevReg AfriSummit 2026, Munyu said patients should be able to trust medicines from the point of approval to the time they reach them.
“When a patient receives a medicine, they should be able to trust it,” Munyu said, noting that patients should not have to question whether medicines were properly assessed, safely stored or entered the supply chain through legitimate channels.
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He said Kenya has strengthened regulatory oversight across the life cycle of medical products, including renewal of marketing authorizations to ensure products remain under regulatory scrutiny even after initial approval.
The PPB has also enhanced inspections of manufacturers, wholesalers and other premises, as poor storage and handling can compromise the quality of medicines after they leave manufacturing facilities.
Munyu said the Board is further strengthening pharmacy practice standards while advancing authentication and traceability systems that will enable regulators to track products through the supply chain and respond more quickly when problems are identified.
He said the country is also increasingly using regulatory reliance, where assessments and inspection outcomes from trusted regulatory authorities are used as evidence to support national regulatory decisions.
Munyu revealed that Kenya's progress through the World Health Organisation Global Benchmarking Tool has helped bring together reforms and sharpen the country's focus on how its regulatory system performs in practice.
The PPB chairperson emphasized that the priority now is to improve the efficiency and transparency of regulatory services while supporting businesses that comply with established standards and taking firm action against substandard and falsified medical products.
He said strong regulation is particularly important because patients benefit when regulatory systems are both rigorous and dependable.
The four-day summit brings together regulators, pharmaceutical and medical device industry players and other stakeholders from across Africa and beyond to discuss regulatory maturity, reliance, local manufacturing, digital systems and supply chain security.
Munyu said the challenges facing the pharmaceutical and medical device sectors are interconnected and require collaboration between institutions and countries.
He called on delegates to use the summit to share experiences, develop partnerships and identify practical solutions that can strengthen regulation across the continent.