Kenya

The Pharmacy and Poisons Board (PPB), established under the Pharmacy and Poisons Act (Cap. 244) of the Laws of Kenya, is the primary national regulatory authority responsible for the registration, control, and oversight of health products including pharmaceuticals, medical devices, diagnostics, and digital health solutions. All health products intended for sale or use in Kenya must undergo PPB evaluation and receive a valid registration certificate before market entry. The approval process generally involves submission of a technical dossier, laboratory testing where applicable, facility inspection for manufacturers, and review by PPB technical committees before a final determination is issued.

Applications to the PPB are typically required to be submitted in Common Technical Document (CTD) format, which aligns with international harmonization standards promoted through the African Medicines Regulatory Harmonization (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD). A local representative or registered agent based in Kenya is mandatory for all foreign manufacturers seeking product registration. Kenya is an active participant in the African Medicines Agency (AMA) framework and has adopted reliance pathways that allow expedited review for products already approved by stringent regulatory authorities such as the US FDA, EMA, or WHO-prequalified products. Notable recent reforms include the integration of an electronic submission portal, increased emphasis on post-market surveillance, and a medical devices regulatory framework that is progressively being strengthened to address diagnostics and digital health tools including software as a medical device (SaMD).

Public procurement of health products in Kenya is primarily coordinated through the Ministry of Health (MoH), with the Kenya Medical Supplies Authority (KEMSA) serving as the central procurement and distribution agency for public health facilities at the national and county levels. Following Kenya's devolution under the 2010 Constitution, the 47 county governments have significant autonomy in health service delivery and may conduct their own procurement processes, although national frameworks and essential medicines lists issued by the MoH provide overarching guidance. Tenders for large-scale public procurement are governed by the Public Procurement and Asset Disposal Act (2015) and overseen by the Public Procurement Regulatory Authority (PPRA), with preference mechanisms in place for locally manufactured or assembled products under the Buy Kenya Build Kenya policy.

Kenya's health sector benefits substantially from donor-funded procurement channels, which complement the public system and often operate through parallel supply chains. Key donors and implementing partners active in Kenya include the Global Fund to Fight AIDS, Tuberculosis and Malaria; USAID and its implementing mechanisms such as PEPFAR and the Global Health Supply Chain Program (GHSC-PSM); Gavi, the Vaccine Alliance; UNICEF Supply Division; and the Clinton Health Access Initiative (CHAI). These channels frequently procure WHO-prequalified or stringent regulatory authority-approved products and may bypass national registration requirements under specific humanitarian or program exemptions. The private sector, encompassing mission facilities, faith-based organizations, and commercial pharmacy chains, sources products through licensed importers and distributors. Local manufacturing is actively encouraged through tax incentives and preferential procurement margins, and Kenya positions itself as a regional manufacturing hub under initiatives supported by the Africa CDC and the Kenyan government's own pharmaceutical manufacturing strategy.