The Pharmacy and Poisons Board (PPB) has declared that 22 per cent of health products that were in circulation in Kenya in 2025 are now non-compliant after manufacturers or marketing authorisation holders failed to submit renewal applications by the December 31, 2025, deadline.
In a regulatory update issued on Friday, February 6, 2026, and signed by Acting Chief Executive Officer Ahmed Mohamed, the board said that out of 9,551 Health Products and Technologies (HPTs) retained and circulating in 2025, 78 per cent either hold valid marketing authorisations or have submitted renewal applications that are currently under review.
The remaining 22 per cent did not meet the renewal deadline and have consequently lost their lawful registration status.
According to the board, these products are no longer eligible for importation, manufacture or distribution in Kenya and must undergo fresh registration in line with applicable regulatory procedures.
“The remaining 22% of HPTs whose renewal applications were not submitted by the stipulated deadline are therefore non-compliant with the statutory and regulatory requirements,” read the statement in part.
The board stated that its mandate under the Pharmacy and Poisons Act, CAP 244, is to protect and promote public health by ensuring access to quality, safe and efficacious health products. Section 3A(c) of the Act empowers the Board to grant, vary, renew or withdraw marketing authorisations, subject to prescribed conditions.
Under Rule 10(1) of the Pharmacy and Poisons (Registration of Health Products and Technologies) Rules, 2022, a certificate of registration or renewal is valid for five years from the date of issuance, after which renewal is mandatory. Any product whose marketing authorisation expires without submission of a renewal application ceases to have lawful registration status.
The board required all marketing authorisation holders with expired or expiring registrations to submit renewal applications by December 31, 2025. As of February 1, 2026, all submitted applications had been screened for completeness.
The PPB noted that applications that passed screening 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 are required to submit responses, with the screening phase expected to be completed within 60 working days from the date of submission.
On importation, the Board reiterated that Rule 3 of the Pharmacy and Poisons Rules, 2022, prohibits the importation of any HPT without a valid import licence. However, applications submitted before expiry and successfully screened may apply for import licences to ensure continuity of access to essential health products.
The board said it continues to apply risk-based regulatory oversight, allowing consideration of manufacturing sites with recently lapsed Good Manufacturing Practice certification where there is documented historical compliance and no reported quality defects or recalls.
GMP inspections are being scheduled based on risk prioritisation, product criticality and public health impact. In addition, the Board has extended GMP certification status for several eligible manufacturing sites.
The PPB has scheduled a stakeholder engagement session on March 4, 2026, to discuss issues affecting the pharmaceutical industry and promote regulatory compliance.
