Renewals Framework for Medicines and Vaccines in Kenya

Pharmacy and Poisons Board, hereafter referred to as “The Board” is mandated under the Pharmacy and Poisons Act to regulate Health products and Health Technologies. Renewals of medicines and vaccines has become a crucial requirement, driven by assessments carried out by the World Health Organization's Global Benchmarking Tool (WHO-GBT). In response, the Board has developed comprehensive Guidelines and Standard Operating Procedures (SOPs) within a renewal framework. This framework encompasses all medicines and vaccines registered in Kenya since 1981. The framework provides guidance for both the regulator (PPB) and applicant in the preparation of a policy on Market Authorization renewal applications to The Board, while ensuring access of medicines and vaccines is not disrupted and that quality, safe and efficacious medicines and vaccines are available during their entire lifecycle. PPB has established and implemented documented procedures and tools for the renewal of medicine and vaccine registrations. Each stage of the renewal process, including application receipt, screening, review, and decision-making, must be thoroughly documented and rigorously implemented. These guidelines explicitly define the appropriate validity periods for initial registrations while outlining the requirements for renewing registrations, which are limited to a five-year cap as mandated by law.