Business Plan Development for Rwanda Food and Drugs Authority

In 2018 Rwanda enacted a law establishing the Rwanda Food and Drug Administration (FDA), which has a clear mandate to protect public health by regulating human and veterinary medicines, vaccines, and medical devices. As with most national regulatory bodies in low-and middle-income countries, the Rwanda FDA faces a challenge of ensuring financial sustainability. It has limited financial resources and needs to become financially sound to meet its mandate.

This technical brief summarizes MTaPS’ efforts to develop a business plan to tackle financial sustainability of the Rwanda FDA. From May 2021 to May 2022, MTaPS with its partner Pharmaceutical Systems Africa (PSA) collaborated with the Rwanda FDA to develop a costed four-year business plan that identifies financial needs, gaps, and sources of revenue of the Authority. The business plan includes strategies for defining or revising fee schemes to expand the Authority’s financial capacity and for establishing appropriate structures for financial management. The “Rwanda FDA Business Plan for Financial Sustainability 2021–2025” is a roadmap for strengthening financial management, enhancing accountability, and ensuring financial sustainability of the Rwanda FDA while reducing dependency on government and donor funding.