Licensing and Approval of Antimicrobials for Use in Animals

Abstract

Registration of Veterinary Medicinal Products ( VICH) has been very successful in harmonizing product quality, human food safety, environmental risk assessment, and efficacy requirements, and those guidelines are highlighted in this chapter. There is general agreement within the scientific community that the development of resistant, human-pathogenic bacteria results primarily from the direct use of antimicrobial agents in humans but also from acquisition of resistant organisms or resistance factors from animal and environmental sources. The direct public health concern is that use of antimicrobials in food-producing animals may contribute to the development or dissemination of antibiotic-resistant zoonotic organisms that may contaminate food products at the time of slaughter and subsequently be transmitted to humans. The indirect effect is where animals are treated with antimicrobials and commensal bacteria develop resistance that may be passed to human-pathogenic bacteria. Licensing and approval of antimicrobials for use in animals, particularly food-producing animals, is a complex process involving considerations of efficacy, target animal safety, environmental safety, and human safety, including antimicrobial resistance. The approval process strives to ensure that the products are effective and safe and to manage the risks of adverse effects from their use. After veterinary drugs are licensed and marketed, surveillance is undertaken to ensure the continued safety and efficacy of the products.