美国FDA 指导原则 CVM GFI 149(VICH GL33)评估人类食品中兽药残留安全性的研究通用检测方法 英文原版.pdfVIP

149 Guidance for Industry Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing VICH GL33 (This version of the guidance replaces the version that was made available in June 27, 2006. This guidance document has been revised by inserting a reference to the 3 R’s Principle (Refine, Reduce and Replace), highlighting the VICH adherence to the goal of minimizing animal testing. FINAL GUIDANCE This final guidance outlines a testing approach to assure human food safety following the consumption of food products derived from animals treated with veterinary drugs. Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the Docket No. 2002D-0326. For questions regarding this document, contact the Division of Human Food Safety, Center for Veterinary Medicine, (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8208. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine March 17, 2009 Contains Non-Binding Recommendations VICH GL33 (SAFETY : GENERAL APPROACH) October 2002 For implementation at Step 7 - Final Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human