Roadmap for the Implementation of Bioequivalence Requirements for Multisource Drug Products in Kenya

The Pharmacy and Poisons Board (PPB), Kenya's national regulatory authority, has the crucial mandate to regulate clinical trials and issue marketing authorization based on assessment of quality, safety, and efficacy documentation submitted by the Market Authorization Holder/applicant. Part of the essential requirements for acquiring market authorization in Kenya is the submission of Bioequivalence (BE) data, crucial to proving the interchangeability of multisource products.

This comprehensive roadmap delineates the specific timelines within which Market Authorization Holders (MAHs) must submit Bioequivalence study data. The primary objective is to prove that multisource (generic) pharmaceutical drug products are therapeutically equivalent and interchangeable with their corresponding innovator’s products. The roadmap not only outlines the criteria for scheduling of mandatory bioequivalence for both new applications and already marketed products but also incorporates a phased approach to ensure the compliance of all marketed products that require bioequivalence are compliant with the standards of quality, efficacy, and safety.