Guidelines

Toxicology

Genotoxicity: Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing
Safety, Toxicology, Pharmaceuticals

VICH GL23(R2) - (Safety) - August 2025 - For implementation at Step 7 in the regions by August 2026

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Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies
Safety, Pharmaceuticals, Toxicology

VICH GL 22(R) – (Safety) - August 2025 - For implementation at Step 7 in the regions by August 2026

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Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
Toxicology

VICH GL54 (Safety) November 2016 - For implementation by November 2017

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Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (chronic) toxicity testing
Toxicology

VICH GL37 (Safety: Repeat-dose chronic toxicity) May 2004 - Implemented in May 2005

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Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to Testing
Toxicology

VICH GL33 (Safety: General Approach) - Final Revision 2 at step 9 - Implemented in February 2010

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Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental Toxicity Testing
Toxicology

VICH GL32 (Safety: Developmental Toxicity) October 2002 - For implementation in October 2003 (Except EU: later date) - Revision 1 of May 2004

Download GL32_st7-Rev.pdf


Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (90 days) Toxicity Testing
Toxicology

VICH GL31 (Safety: Repeat-dose Toxicity) October 2002 - Implemented in October 2003 - Revison 1 of May 2004

Download GL31_st7-Rev.pdf


Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing (Revision at Step 9)
Toxicology

VICH GL28 (Safety: Carcinogenicity) October 2004 - Implemented in March 2006

Download Gl28_st7F.pdf