Kenya

The Pharmacy and Poisons Board (PPB) is the primary national health regulatory authority in Kenya, established under the Pharmacy and Poisons Act (Cap. 244) of 1957 and subsequently amended to reflect evolving regulatory demands. The PPB oversees the registration, importation, exportation, manufacture, and distribution of health products, including pharmaceuticals, medical devices, diagnostics, and increasingly, digital health solutions. All health products intended for the Kenyan market must undergo a formal product registration process administered by the PPB, which evaluates safety, quality, and efficacy prior to granting market authorization. The review process involves technical evaluation by PPB expert committees, site inspections where relevant, and a formal approval decision communicated to the applicant.

Applicants are required to submit a comprehensive registration dossier aligned with the Common Technical Document (CTD) format, and the PPB also accepts dossiers prepared according to the ACTD (ASEAN Common Technical Dossier) and other internationally recognized standards. A locally registered entity or a designated local representative or agent is mandatory for all foreign manufacturers seeking product registration. Kenya is a member of the African Medicines Regulatory Harmonisation (AMRH) initiative and participates in the East African Community (EAC) Medicines Registration Harmonisation (MRH) program, which allows for joint reviews and mutual recognition of approvals across member states, reducing duplication of effort. Recent reforms have included the introduction of an expedited review pathway for priority and essential health products, a risk-based classification framework for medical devices, and digitization of submission and tracking processes through the PPB online portal.

Public procurement of health products in Kenya is governed primarily through the Kenya Medical Supplies Authority (KEMSA), which serves as the central procurement and distribution agency for public health facilities under the Ministry of Health. KEMSA operates under the KEMSA Act (2013) and is responsible for aggregating demand, tendering, warehousing, and distributing medicines, diagnostics, medical devices, and other health commodities to county and national health facilities. The Public Procurement and Asset Disposal Act (2015) provides the overarching legal framework for all public sector procurement activities, with the Public Procurement Regulatory Authority (PPRA) providing oversight and compliance monitoring. Kenya operates a devolved governance structure under its 2010 Constitution, meaning that county governments have significant autonomy in health service delivery and may conduct their own procurement for certain commodities outside the KEMSA framework, creating a dual-layer procurement environment at both national and county levels.

The private sector in Kenya is substantial and well-developed, with private hospitals, pharmacies, and diagnostic laboratories sourcing products through independent distributors, importers, and direct manufacturer channels outside the KEMSA system. Multinational donor and financing organizations play a significant role in Kenya's health commodity landscape: the Global Fund finances procurement of HIV, tuberculosis, and malaria-related products; USAID through its implementing partners supports supply chain strengthening and direct commodity provision; Gavi supports vaccine procurement and cold chain investments; and UNICEF facilitates supply of essential health products through its Supply Division. The Government of Kenya has increasingly emphasized local manufacturing preference policies, including preferential margins for locally manufactured goods under public tenders, and actively supports the broader Africa CDC and African Union agenda to expand domestic pharmaceutical and health product manufacturing capacity, positioning Kenya as a regional manufacturing hub in East Africa.