Health sector is one of the fastest growing in the country, having posted solid pillars such us financing mechanisms, decentralisation and community healthcare services. Despite rapid growth levels, Pharmaceutical products quality assurance should properly be regulated in order to efficiently protect the Rwanda Public health by assuring Safety, Efficacy and Quality of all regulated products.
Hence regulation of Food and Pharmaceutical products requires well build regulatory system for quality and regulatory best practices, promoting local pharmaceutical production, and facilitating regulated industrial economic growth.
Rwanda FDA is established by the Law Nº 003/2018 of 09/02/2018 with clear mandate to protect public health, Human and Veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco & tobacco products and conduct of clinical trials. This requires the Authority to have a well-designed and strong system for regulatory compliance.