Kenya

Kenya regulates pharmaceutical products through the Pharmacy and Poisons Board (PPB), established under the Pharmacy and Poisons Act (Cap. 244, Laws of Kenya). PPB is the lead authority for the registration, manufacture, importation, distribution and post-market surveillance of human and veterinary medicines, medical devices, in-vitro diagnostics, cosmetics, herbal and complementary products, and the licensing of pharmacists and pharmaceutical premises. Marketing authorisation is evidenced by a PPB Certificate of Product Registration, valid for 5 years. PPB achieved WHO Maturity Level 3 (ML3) for medicines in 2024, the first National Regulatory Authority in the East African Community (EAC) and among the first in Africa to do so. PPB operates Standard, Reliance / Verification / Abridged and Emergency Use Authorisation pathways, with formal recognition of Stringent Regulatory Authorities, WHO Listed Authorities and WHO Prequalification under its Guidelines on Reliance (2021, revised 2023). Kenya is a leading participant in the East African Community Medicines Regulatory Harmonisation (EAC-MRH) joint assessment programme, the African Medicines Regulatory Harmonisation (AMRH) initiative and the African Medicines Agency (AMA) treaty. Public-sector access runs through the Social Health Authority (SHA, established under the Social Health Insurance Act, 2023, replacing the former NHIF), the Kenya Medical Supplies Authority (KEMSA), county-level procurement and donor-funded programmes (Global Fund, PEPFAR, GAVI). Pricing is largely market-driven for innovator products, with capped prices for selected essential and oncology medicines under the Kenya Essential Medicines List (KEML).