Kenya

The Pharmacy and Poisons Board (PPB) is the primary national regulatory authority responsible for the registration and control of health products in Kenya, operating under the Pharmacy and Poisons Act (Cap. 244) and supported by subsidiary legislation including the Pharmacy and Poisons (Amendment) Regulations. All health products, including pharmaceuticals, medical devices, diagnostics, and biologicals, must be registered with the PPB before they can be legally imported, manufactured, or sold in the country. The registration process involves a formal application, technical dossier review, and where applicable, product testing and facility inspection. The PPB has progressively adopted risk-based approaches to streamline reviews, and products that have received approval from stringent regulatory authorities (SRAs) such as the EMA, US FDA, Health Canada, or the TGA may be eligible for an expedited review pathway.

Applicants must appoint a locally registered entity or agent as the in-country representative responsible for post-market surveillance obligations and regulatory correspondence. Dossiers are generally accepted in the Common Technical Document (CTD) format, and alignment with the African Union Development Agency (AUDA-NEPAD) African Medicines Regulatory Harmonization (AMRH) framework is increasingly reflected in PPB procedures. Kenya is an active participant in the East African Community (EAC) Medicines Regulatory Harmonization Initiative, which enables joint reviews and mutual recognition of approvals across member states, reducing duplication for regional applicants. The PPB has also introduced an online submission portal to modernize and improve transparency in the registration process, and it continues to develop specific guidance for medical devices and in-vitro diagnostics as distinct product categories separate from pharmaceuticals.

Public sector health product procurement in Kenya is primarily coordinated through the Kenya Medical Supplies Authority (KEMSA), a state corporation under the Ministry of Health (MOH) mandated to procure, store, and distribute medical commodities to public health facilities nationwide. KEMSA operates through framework agreements and competitive tendering processes governed by the Public Procurement and Asset Disposal Act (2015) and overseen by the Public Procurement Regulatory Authority (PPRA). County governments, empowered by the Constitution of Kenya 2010 and the devolution framework, also conduct their own procurement for county-level health facilities, creating a two-tiered procurement landscape where both national and county authorities may independently source health products. Suppliers are generally required to be registered with the PPB and meet specific quality standards, including WHO Good Manufacturing Practice (GMP) certification, to participate in public tenders.

The private sector plays a significant role in Kenya's health market, served by a network of licensed pharmaceutical wholesalers, distributors, and retail pharmacies concentrated in urban centers such as Nairobi, Mombasa, and Kisumu. International donor-funded channels are also critical, with organizations such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its global health programs (including PEPFAR and PMI), and Gavi, the Vaccine Alliance, collectively channeling substantial volumes of health commodities into the country, often through parallel supply chains that bypass KEMSA. Local manufacturing preference policies are emerging, with the government's Vision 2030 and subsequent industrial strategies encouraging domestic pharmaceutical production; preferential margins of up to 15 percent may be applied in favor of locally manufactured products in public tenders. Kenya's designation as a hub for the Africa Centres for Disease Control and Prevention (Africa CDC) and regional health initiatives further reinforces its strategic importance as a procurement and distribution gateway for East and Central Africa.