Rwanda has made significant progress toward strengthening its pharmaceutical sector. Most notably, 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.
Despite this commendable step, the pharmaceutical system in Rwanda faces challenges. These include weak policies and legislation governing the availability and use of pharmaceuticals and related health products; gaps in the institutional and human resource capacity of the pharmaceutical sector to perform its regulatory functions, including product registration, inspection, pharmacovigilance (PV), and medicine quality testing; insufficient monitoring of medicine safety and rational use; and issues with the overall management and delivery of pharmaceutical services at the facility level.
These problems stem from not only limited financial resources but also insufficient skills for effective pharmaceutical management, inadequate availability and use of strategic information, and limited monitoring and supervision of pharmaceutical services at the facility level.
MTaPS focuses on the following technical areas:
Strengthening regulations and guidelines
MTaPS is providing technical assistance to strengthen pharmaceutical-sector governance by working with the Pharmacy Unit under the Ministry of Health (MOH) and developing standards and an accreditation system for pharmaceutical services in the country in collaboration with the National Pharmacy Council and the Rwanda FDA. MTaPS Rwanda is supporting the Government of Rwanda in developing regulations and guidelines for the Rwanda FDA that are required for full implementation of the functions of the authority.
Supporting more efficient health information systems
The Rwanda FDA has established an online portal to carry out key functions such as product registration, inspection, import-export, and finance. The functionality of the system will be assessed and compared to the needs of the current and future regulatory systems. MTaPS is providing technical assistance to the Rwanda FDA to promote the consistent use of electronic systems for registration and inspection of pharmaceutical products.
Building governing capacity
MTaPS is working with the MOH to fully establish a pharmacy unit, including developing terms of reference, job descriptions, and a quality services manual. The program is also advocating for an increase in human resources for the unit by recruiting technical staff to handle policy formulation and oversight of pharmaceutical services.
Although Rwanda has a PV system for capturing data on adverse drug reactions, it has failed to provide adequate active safety monitoring of priority medicines. MTaPS, in collaboration with partners and public health programs for HIV and TB, is building the capacity of the Rwanda FDA’s pharmacovigilance system. This includes establishing electronic tools and protocols for more accurate and efficient tracking, including PViMS, a web-based application that can be used by clinicians, regulatory bodies, and implementing partners to monitor the safety of medicines. It will link to PRIMS, an online government pharmaceutical regulatory management system.