The Pharmacy and Poisons Board (PPB) has said that most of health products and technologies in circulation in Kenya have either valid marketing authorizations or renewal applications under regulatory review.
According to PPB, as at 1st February 1 2026, 78 per cent of the 9,551 HPTs that were retained and in circulation
in 2025 either hold valid Marketing Authorizations or have submitted renewal
applications currently under regulatory review.
In a regulatory update issued on February 5, 2026, the Board said the level of compliance shows strong participation by industry players in meeting regulatory requirements.
The PPB is mandated under the Pharmacy and Poisons Act to protect public health by ensuring access to quality, safe and efficacious health products and technologies.
The Board explained that marketing authorization certificates are valid for five years and must be renewed before expiry.
It required all holders of expired or expiring registrations to submit renewal applications by December 31, 2025.
The PPB said 22 per cent had not submitted renewal applications by the deadline.
The Board said these products are non-compliant with statutory and regulatory requirements.
“These non-compliant HPTs are required to undergo fresh registration in accordance with the applicable regulatory procedures,” PPB said.
The PPB said all submitted renewal applications have been screened for completeness.
Applications have either progressed to technical evaluation or been issued with requests for additional information to assure continued product quality, safety and efficacy.
Stakeholders issued with screening queries have been asked to submit responses, noting that the Board will complete the screening phase within 60 working days from the date of submission.
On importation, the Board reiterated that no health product may be imported into Kenya without a valid import licence.
However, to ensure continuity of access to essential products, applications submitted before expiry and successfully screened may apply for import licences.
The PPB said it will continue to prioritise evaluation of renewal applications based on public health risk, therapeutic importance and alignment with national public health programmes, including products supporting chronic disease management.
The Board also noted that, as part of risk-based regulatory oversight, it has continued to allow consideration of some manufacturing sites with recently lapsed Good Manufacturing Practice certification where there is documented historical compliance and no reported quality defects or product recalls.
It said GMP inspections are conducted based on risk prioritisation, product criticality and public health impact, in line with national requirements and international best practices.
In addition, the PPB has extended GMP certification status for several eligible manufacturing sites as part of risk mitigation measures.
The Board said it conducts regular stakeholder engagements to address emerging challenges, facilitate information sharing and promote compliance.
In this regard, it has scheduled a stakeholder engagement session on March 4, 2026, to discuss matters affecting the pharmaceutical industry.
The PPB said it remains committed to protecting and safeguarding public health and will continue to provide technical guidance to support sustained regulatory compliance.