Bioequivalence Systems in Kenya: Feasibility, Implementation Strategies, and Regulatory Insights

Bioequivalence (BE) studies are essential for ensuring the safety, effectiveness, and quality of pharmaceuticals. Since 2010, locally manufactured multisource drug products (MSDPs) in Kenya have been exempt from BE study requirements, which are mandatory for imported products. To enhance medicine quality and achieve World Health Organization Global Benchmarking Tool (WHO-GBT) Maturity Level 3 (ML-3) accreditation, the Pharmacy & Poisons Board (PPB) developed a BE Implementation Framework. This framework mandates that all new drug registration applications include BE data, and renewals require BE data starting in 2025. However, challenges such as financial burdens on local manufacturers, limited infrastructure, and human resource gaps for conducting BE studies locally were identified. To address these issues, PPB, with support from the Bill & Melinda Gates Foundation, engaged Penam Ltd Consultants to conduct feasibility studies and risk assessments for mandatory BE studies on locally manufactured MSDPs.
Conducted over three months, the multimodal qualitative study involved literature review, stakeholder engagements, surveys, and key informant interviews.
Stakeholders broadly supported BE enforcement for safer medicines but expressed concerns over costs and inadequate infrastructure. Eighty-five percent of respondents emphasized the need for human resource capacity-building. Key recommendations included phased BE implementation, risk-based prioritization, public-private partnerships, modular BE services, and financial incentives for local manufacturers.
The BE Plan of Action (2024–2026) that was prepared in the study proposed a USD 6.05 million budget for technical assistance, facility upgrades, and pilot BE studies for at least 20 priority local products.