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Overview

Rwanda Food and Drugs Authority hereafter designated as the “Authority”, was established by the law Nº 003/2018 of 09/02/2018 determining its mission, organization and functioning. The mandate of the Authority is to protect public health through regulation of human and veterinary medicines, vaccines and other biological products, processed foods, poisons, medicated cosmetics, medical devices, household chemical substances, tobacco and tobacco products.

Human Medicines Registration

The Human Medicines and Diagnostics Registration Division is responsible for:

  1. Conducting scientific evaluation of submitted products’ dossiers to assess quality, safety, and efficacy of the below products prior to the granting of Marketing Authorization (MA): 

 

i. Pharmaceutical and other health products

  • human medicines and vaccines ; 

    • narcotics and psychotropic drugs, and other controlled substances; 

      • blood and blood products; 

      • biopharmaceutical products; 

      • radiopharmaceutical products; 

      • nanotechnology-based drugs and therapies; 

      • advanced therapies including gene-therapies, 

      • cell-based products and regenerative medicines; 

      • other human and biological products used as medicines;

      • Clinical trial investigational products regulated under the scope of this Order;

      • Herbal medicines;

      • Tobacco and nicotine products;