Mission of Rwanda FDA under LAW Nº 003/2018 OF 09/02/2018

  • regulate pharmaceutical products, vaccines, human and veterinary processed foods and other biological products used in clinical as drugs food supplements, food fortificants fortified foods, poisonous substances, herbal medicines, medicated cosmetics, medical devices, tobacco and tobacco products, management of unfit pharmaceutical and food products and clinical trials on pharmaceutical products for human and veterinary use;
  • regulate compliance with quality standards relating to the manufacture, storage, sale, distribution, use, import and export, labels, packages and raw materials used in the manufacture of products regulated under this Law;
  • regulate laboratory and cleaning chemicals and pesticides as well as premises involved in the manufacture of products regulated under this Law;
  • establish, approve and publish the list of human and veterinary food and pharmaceutical products as well as other products regulated under this Law for which marketing authorization has been granted;
  • establish and publish the list of prohibited cosmetics;
  • establish the quality assurance and quality control of products regulated under this Law through designated quality control laboratories when necessary;
  • to regulate and inspect clinical trials;
  • ensure that processed food, food supplements and fortified food meet the prescribed quality standards before they are placed on the market;
  • conduct pharmacovigilance and post marketing surveillance for safety and quality of products regulated under this Law;
  • follow up and analyse information on the use of pharmaceutical products that are subject to global drugs safety monitoring;
  • regulate and analyse information used in the promotion, advertising and marketing of products regulated under this Law;
  • regulate the use of unregistered products regulated under this Law for clinical trial purposes or compassionate use;
  • disseminate information on quality and safety of products regulated under this Law to health professionals and to other concerned persons;
  • conduct research and studies on food and pharmaceutical products and publish the findings in order to promote investment;
  • build cooperation and partnership for harmonization of practices with regional and international bodies with similar missions;
  • to advise the Government on matters regarding the products regulated under this Law;

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