title: The role of veterinary medicine regulatory agencies.
abstract: An effective animal medicine regulatory programme includes a systematic, evidence-based means of documenting the safety and effectiveness of products before they are produced, marketed or used in a particular country or region. The programme must also include adequate monitoring and controls over the use of these substances. It is clearthat such programmes provide veterinarians, farmers and other animal medicine users with greater assurance that veterinary drugs and biologicals will be safe and effective in preventing and mitigating disease. It is important that these regulatory controls include programmes to ensure that human food obtained from treated animals is safe and that all potential toxicological and microbiological hazards that may be associated with the use of veterinary medicines have been adequately evaluated. There is a great need worldwide for veterinary medicines that provide needed therapies for vast numbers of animals and animal species and, in the case of food-producing animals, for medicinal products that enhance the productivity and efficiency of food production and ensure food safety when they are used in accordance with their approval specifications. The public health mission of regulatory agencies succeeds when they are able to put into the hands of the user an approved, safe and effective, well-manufactured and appropriately labelled medicine, and when there are adequate controls in place to assure proper compliance.
authors.affiliation: International Programs and Product Standards, Center for Veterinary Medicine, Food and Drug Administration, Rockville, Maryland 20855, USA. Merton.Smith@fda.hhs.gov
authors.forename: M V
authors.initials: MV
authors.lastname: Smith
mesh_terms: D000818:Animals; D059022:Food Safety; D006076:Government; D006801:Humans; D007880:Legislation, Drug; D007886:Legislation, Veterinary; D019155:Veterinary Drugs; D014730:Veterinary Medicine / Q000592:standards*
chemical_list: D019155:Veterinary Drugs