About Animal Medicines

Regulation

AHI members develop medicines that protect the health and enhance the well-being of animals. These animal medicines are vigorously researched and tested for safety, purity and efficacy by our member companies before being submitted for additional review, research, testing and, ultimately, approval by government regulatory agencies. The agencies involved in the approval and regulatory process of our members’ products include the FDA (pharmaceuticals), the USDA (biologics) and the EPA (pesticides).

Safety and Oversight
Animal pharmaceuticals, biologics and pesticides are highly regulated by the U.S. government. Navigating the regulatory pathways for new products takes an average of five to seven years, and the research and development process requires the investment of millions of dollars. The results are products that the animal health industry and the American public can count on to be pure, safe, potent and effective.

  • USDA Center for Veterinary Biologics (CVB): Evaluates the purity, safety, potency and effectiveness of all vaccines and biological products prior to licensing. The review process, which includes challenge studies, safety trials and manufacturing testing, can take three to five years.
  • Food and Drug Administration (FDA)/Center for Veterinary Medicine (CVM): Tests, approves, licenses and regulates all pharmaceutical products. When a new drug has been determined to be a potentially useful medicine,  the pharmaceutical company begins working closely with the FDA to review development plans and to set up testing protocols. Reviews of studies and testing continue throughout the process, which can take seven to 10 years before approval is granted.
  • Environmental Protection Agency (EPA): Evaluates the safety and effectiveness of pesticides, and develops safety guidelines to closely oversee their use. Manufacturers must provide scientific evidence demonstrating with reasonable certainty that a product will cause no harm to humans, the environment or non-target species. The process from discovery through long-term toxicology studies and EPA review takes, on average, five to seven years.