Veterinary regulations in animal health can be categorized by which country or geographical region the approval is intended, and by the product being evaluated. Before entering into a veterinary clinical trial, it is important to verify which agency has regulatory purview over the clinical trial, as this will influence the various authorizations required to initiate your trial.
United States: regulatory oversight for animal health products are routinely covered by one of three federal agencies, being the Food and Drug Administration Center for Veterinary Medicine (FDA-CVM), United States Department of Agriculture Center for Veterinary Biologics (USDA-CVB), and the Environmental Protection Agency (EPA).
Europe: the European Medicines Agency (EMA) oversees sponsors developing and marketing veterinary products in the European Union (EU).
US, Canada and European Regulations
Veterinary Regulations in the US
In general, the following applies to animal health products in the United States. The FDA-CVM regulates veterinary drugs and pharmaceuticals, including having purview of veterinary medical devices and dietary supplements. The USDA-CVB regulates veterinary biologics (vaccines, immune modulators, antitoxins, antibody products) and veterinary diagnostic kits. The EPA regulates veterinary pesticides and ecto-parasitics, such as flea and tick products.
Veterinary Regulations in Canada
In Canada, veterinary pharmaceuticals are regulated by the Veterinary Drugs Directorate (VDD). The VDD is responsible for evaluation and monitoring the safety and efficacy data, and for advocating the responsible use of veterinary drugs in companion animals and livestock.
Pet foods and feeds are regulated by the Canadian Food Inspection Agency.
Veterinary Regulations in Europe
In Europe, the European Medicines Agency (EMA) oversees the approval of medical products for veterinary use. Medical products are defined as “A substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action.” As such, the EMA regulates all veterinary products including vaccines, pharmaceuticals, biologicals, and pesticides. Further information concerning the regulations can be found in the EudraLex publication Volume 5.