Veterinary Regulations

Good Clinical PracticeVeterinary 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).

Veterinary Regulatory Links

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.

Other Countries Veterinary Regulatory Information

Brazil

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Other countries

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Veterinary International Conference on Harmonization

The VICH stands for Veterinary International Conference on Harmonization (VICH), which is an international cooperative program between the United States, Europe, and Japan (tripartite) to harmonize the technical requirements for registering veterinary medicine (veterinary pharmaceutical) products.  The VICH has a steering committee to manage the harmonization process, generate draft guidelines for input, and to implement the final guidelines to be ratified.  The VICH also has expert working groups (EWGs) to develop specific guidelines in their areas of expertise.  The VICH’s overall objective is to reduce unnecessary duplication and associated costs of technical requirements for registering veterinary products, including target animal safety and efficacy testing.   The VICH process is meant to ensure an efficient and consistent method for the interpretation of data requirements through dialogue among various regulatory authorities and the animal health industry.  The VICH also is designed to reduce delays in global product development through implementing (a) harmonized standards for the registration of veterinary pharmaceuticals and (b) post-market surveillance of registered products through pharmacovigilance requirements.