Medicines regulator set for world’s top status

Pharmacy and Poisons Board CEO Dr Ahmed Mohamed speaks to the Star

Kenya is stepping up efforts to upgrade its medicines regulator, the Pharmacy and Poisons Board, to a higher global standard.

This is expected to transform how drugs are approved, monitored and manufactured in the country.

The regulator is currently ranked at Maturity Level 2 by the World Health Organization (WHO), but is now targeting Level 3, a milestone that signals a stable and well-functioning system capable of consistently protecting public health.

PPB chief executive officer Dr Ahmed Mohamed said the transition is central to his vision for the institution, with reforms already underway to improve efficiency, transparency and patient safety.

“We are currently at Maturity Level 2, and we are moving towards Level 3. The most critical factor that delayed our move to Level 3 was human resources,” he said.

“We have an establishment requirement of almost 350 staff, but we have been operating with around 160, which is nearly a 50 per cent shortage. Fortunately, the Ministry of Health has been very supportive. Through a World Bank grant and Treasury approvals, we are now employing about 80 new people to close that gap.”

WHO uses four levels to rate national medicines regulators. Level 1 shows basic systems are in place. Level 2 means the system is developing. Level 3, which Kenya is pursuing, indicates a strong and reliable regulator. Level 4 is the highest rank, reserved for advanced agencies operating at global best practice.

“The higher the maturity level, the more confidence the public can have in the system. It means that every product that reaches the patient has gone through a robust process,” Ahmed said.

“Level 4 represents what we call World-Listed Authorities, which are the most trusted systems globally, but Level 3 already places you in a strong position.”

Reaching Level 3 would also put Kenya in a more competitive position globally, aligning it more closely with mature regulatory systems and making it easier for locally manufactured medicines to access international markets.

But beyond global rankings, Ahmed, who was recently appointed PPB boss in acting capacity, said his immediate focus is to reshape the regulator into a patient-centred institution.

“We serve as the watchdog for public health when it comes to health products and technologies,” he said.

“Our mandate is built on three pillars: ensuring safety, quality and effectiveness of every product.”

“Our current strategy is focused squarely on the patient rather than the commercial interests of the pharmaceutical industry, because that is the fundamental reason for our existence,” he said.

“Every reform we are undertaking is guided by that principle, to ensure that the Kenyan patient is protected at all times.”

As part of this shift, the board has rolled out major internal reforms, including digitising its systems and expanding its presence across the country.

“We have undertaken several strategic reforms aimed at strengthening regulatory efficiency, transparency and public health protection,” Ahmed said.

“This involves modernising our digital platforms, expanding our human resource capacity and operationalising regional offices so that our services are closer to the people.”

Ahmed said decentralisation will make it easier for Kenyans to report illegal pharmacies, substandard medicines or suspicious products.

“It is often surprising to note that a doctor’s prescription is not the end of the process,” he said.

“If a patient takes a drug like paracetamol and it does not cure their headache as expected, they need to know what to do next. You do not need to be certain that a drug is bad; even suspicion is enough. That is where we take over the investigation.”

The regulator has also strengthened post-market surveillance, meaning drugs are monitored even after approval. Its laboratories now operate 24 hours a day, sampling medicines across the country to ensure they meet required standards.

At the same time, Kenya is positioning itself as a future hub for pharmaceutical manufacturing, backed by growing investor confidence and a pipeline of new facilities.

Ahmed said a strong regulator is key to that ambition.

“Health products and technology are a matter of national security. We saw what happened during Covid-19 when countries locked down and exports stopped,” he said.

“The only way to prevent such a crisis is to develop local capacity. A credible regulatory system supports industry growth while ensuring products meet global standards.”

Another critical area under reform is the process of approving new medicines, which often determines how quickly patients can access treatment.

Globally, drug approval can take between two and five years. In Kenya, the PPB has set a target of 24 months, placing it among the more efficient regulators worldwide.

“Drug registration involves many complex processes. It is not a matter of simply sitting and approving a file,” Ahmed said.

“We require bioequivalence data for generic drugs to ensure they are therapeutically equivalent to the original product. We must also verify stability data to ensure the product remains safe over its shelf life.”

“We audit the entire manufacturing process, including the equipment used, to confirm compliance with good manufacturing practices,” he added.

“Our two-year timeline actually makes us one of the best and most efficient regulators in the world, while still maintaining strict standards.”

To speed up access to critical medicines, the PPB also uses a system known as reliance, where it considers approvals from trusted global regulators.

However, Ahmed insists this does not mean Kenya is lowering its standards.

“Reliance is a fast-track mechanism for public health benefit. It does not mean we do not review the scientific documentation,” he said.

“An applicant must submit the full dossier that was presented to agencies like the US FDA or the WHO. We still conduct our own assessment, but we do it faster.”

As Kenya pushes towards WHO Maturity Level 3, the reforms may not always be visible to the public. But their impact is expected to be far-reaching.

A stronger regulator will mean safer medicines, fewer substandard products and quicker access to new treatments. It will also support local manufacturing and reduce reliance on imports.