Kenya will adopt US Food and Drug Administration (FDA) approvals to allow certain medicines and medical products to enter the country for both emergency and routine use, according to a newly signed five-year Kenya-US Health Cooperation Framework Agreement.
The arrangement, set to be fully operational by December 2026, marks a departure from the past practice where Kenya’s Pharmacy and Poisons Board (PPB) conducted independent reviews even for products already cleared by the FDA.
Under the new framework, FDA authorisation will be sufficient for products to gain clearance in Kenya, though “subject to verification of product sameness and the applicable review processes of the PPB and other applicable regulatory bodies.”
The agreement clarifies that this provision is not limited to emergency measures but also covers regular medicines, new chemical compounds, vaccines, biologics, diagnostics, and other health-related innovations.
The deal includes plans for training and capacity development for PPB staff to ensure the regulatory system continues to function effectively.
Additionally, the framework aims to assist American companies in setting up operations in Kenya, signaling a broader strategy to expand US business presence in the country.
With this new reliance on the FDA, the PPB will base regulatory decisions on US authorisations, particularly for products from American firms.
The America First Global Health Strategy (AFGHS), which guides the agreement, identifies opportunities to increase access to US-made medicines in emerging markets. It also promotes regional regulatory harmonisation initiatives, such as the African Medicines Agency.
US officials in Nairobi said the partnership is intended to prevent delays in delivering medicines, vaccines, and diagnostic tools during emergencies. Susan Burns, Charge d’Affaires at the US Embassy in Nairobi, described the agreement as a move toward more efficient operations.
“We definitely are looking at more efficient ways to do direct assistance, government-to-government. That’s gonna be done in the implementation phase over time so that we are making sure there’s not any interruptions to care for patients,” she said.
Kenya’s pharmaceutical market, valued at $765.60 million in 2024, is projected to grow at an annual rate of 6.05 per cent through 2030.
Observers say the framework will simplify access to vital medical products while encouraging innovation and investment in Kenya’s healthcare sector.
