Issue Date: April 24, 2009
Issued by: Center for Veterinary Medicine
Topic(s): Target Animal – Safety, VICH
Status: Final
CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products
Data from target animal safety (TAS) studies are required for registration of veterinary products in the regions participating in the VICH. International harmonization of standards for essential TAS studies will facilitate adequacy of data and minimize the need to perform separate studies for regulatory authorities of different countries. Appropriate international standards should reduce research and development costs by minimizing repetition of similar studies in each region. Animal welfare should benefit because fewer animals may be needed. This VICH TAS guidance has been developed as a harmonized standard to aid in development of mutually acceptable TAS studies for relevant governmental regulatory bodies. This guidance document is intended to cover TAS evaluation for any IVPP used in the following species: bovine, ovine, caprine, feline, canine, porcine, equine, and poultry (chickens and turkeys). The recommendations in this guidance may not be appropriate for registration by national or regional authorities of products for use in minor species or minor uses. The guidance does not provide information for the design of TAS studies in other species, including aquatic animals.
Download the Guidance Document
