Law establishing Rwanda Food and Drugs Authority and Determining its Mission, Organisation and Functioning (Law 3 of 2018).

This Law establishes Rwanda Food and Drugs Authority (FDA) and determines its mission, organization and functioning.This law regulates the production, sale, and safety standards of a wide range of pharmaceutical, biological, and chemical products, including drugs, vaccines, medical devices, processed foods, herbal medicines, and tobacco. The Rwanda FDA's mission includes regulating the safety, quality, and compliance of pharmaceutical products, vaccines, processed foods, medical devices, and other related items, while overseeing clinical trials and post-marketing surveillance. It ensures that products meet prescribed standards for manufacturing, storage, distribution, and labeling, and manages the authorization and control of regulated items, including the publication of approved and prohibited products. Additionally, it conducts research, pharmacovigilance, and provides guidance to the government on relevant matters, fostering collaboration with regional and international regulatory bodies. The Law consists of 38 Articles divided into VI Chapters.