International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); final guidance for industry on "studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing" (VICH GL23); availability. Notice.
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (116) entitled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food:Genotoxicity Testing" (VICH GL23). This final guidance has been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products(VICH) from a guidance regarding pharmaceuticals for human use, which was adopted by the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH). This final VICH guidance document recommends a basic battery of tests that can be used to evaluate the genotoxicity of veterinary drug residues in human food in the European Union, Japan, and the United States
D000818:Animals; D003226:Congresses as Topic; D017277:Drug Approval; D004341:Drug Evaluation / Q000592:standards; D005062:European Union; D005506:Food Contamination; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D009152:Mutagenicity Tests / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration; D019155:Veterinary Drugs / Q000633:toxicity*
D019155:Veterinary Drugs