Kenya

The Pharmacy and Poisons Board (PPB) is the primary national regulatory authority responsible for overseeing the registration, licensing, and post-market surveillance of health products in Kenya, including pharmaceuticals, medical devices, diagnostics, and increasingly digital health solutions. The PPB operates under the Pharmacy and Poisons Act (Cap. 244) and its subsequent amendments, which provide the legal framework for product approval, quality assurance, and market authorization. All health products must obtain a valid Certificate of Registration from the PPB before they can be legally marketed or distributed in Kenya. The general approval process involves submission of a product dossier, technical review by PPB evaluators, laboratory testing where applicable, and a final authorization decision communicated to the applicant.

Submissions to the PPB are generally required to follow the Common Technical Document (CTD) format, which aligns with international harmonization standards and is consistent with requirements promoted by the African Medicines Regulatory Harmonisation (AMRH) initiative and the African Union Development Agency (AUDA-NEPAD). Applicants are required to appoint a local authorized representative or agent registered with the PPB to facilitate correspondence and regulatory compliance. Kenya is an active participant in the East African Community (EAC) mutual recognition and joint review frameworks, which can offer expedited pathways for products already approved by recognized stringent regulatory authorities (SRAs) such as the EMA, US FDA, or Health Canada. In recent years, the PPB has implemented digital reforms through its e-submission portal to streamline dossier uploads and application tracking, and has introduced provisions for expedited review of priority health products, including those addressing public health emergencies.

Public procurement of health products in Kenya is primarily coordinated through the Ministry of Health (MoH) in collaboration with the Kenya Medical Supplies Authority (KEMSA), the statutory body mandated to procure, warehouse, and distribute medical commodities to public health facilities across the country. National-level procurement follows the Public Procurement and Asset Disposal Act (2015), overseen by the Public Procurement Regulatory Authority (PPRA), which ensures transparency, competitive tendering, and accountability in government purchasing. County governments, operating under Kenya's devolved system established by the 2010 Constitution, also conduct their own procurement for facility-level needs, creating a dual-layer procurement landscape where both national and county tenders are relevant entry points for suppliers. Framework contracts and long-term agreements are commonly used for high-volume essential medicines and medical supplies.

The private sector constitutes a significant and growing share of Kenya's health product market, encompassing private hospitals, faith-based health networks (such as those coordinated by the Kenya Christian Health Association, KCHA), retail pharmacies, and private diagnostic laboratories. These entities procure independently through commercial distributors and direct supplier agreements, often without the pricing constraints of public tenders. Kenya also benefits substantially from donor-funded procurement channels, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its implementing partners (such as GHSC-PSM), UNICEF Supply Division, and Gavi the Vaccine Alliance, which collectively finance a large proportion of HIV, malaria, tuberculosis, and immunization commodities. The government has articulated a preference for local manufacturing development through initiatives such as the Kenya National Pharmaceutical Policy and alignment with the African Union's Pharmaceutical Manufacturing Plan for Africa (PMPA), offering incentives and preferential consideration to locally manufactured products as part of a broader strategy to strengthen domestic health industry capacity and reduce import dependency.