VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies - Scientific guideline

This document aims to ensure international harmonisation of reproduction testing, which is appropriate for the evaluation of risks to reproduction from long-term, low-dose exposures, such as may be encountered from the presence of veterinary drug residues in food. It provides guidance on the core requirement for a multigeneration study for those veterinary medicinal products that leave residues in human food.

Keywords: VICH, consumer safety, reproduction toxicity, residues of veterinary drugs in human food

Current effective version

VICH GL22: Safety studies for veterinary drug residues in human food: Reproduction studies - Step 7

Adopted Reference Number: CVMP/VICH/525/00-FINAL Legal effective date: 01/07/2002

Revision 1

VICH GL22(R) - Studies to evaluate the safety of residues of veterinary drugs in human food reproduction testing (Revision 1)

Draft: consultation closed Consultation dates: 15/02/2024 to 31/07/2024 Reference Number: EMA/CVMP/VICH/525/2000 Summary:

This Guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft will be recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

Document history

VICH GL22(R) - Studies to evaluate the safety of residues of veterinary drugs in human food reproduction testing (Revision 1)

Draft: consultation closed Consultation dates: 15/02/2024 to 31/07/2024 Reference Number: EMA/CVMP/VICH/525/2000 Summary:

This Guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft will be recommended for adoption to the regulatory bodies of the European Union, Japan and USA.

Comments should be provided using this template. The completed comments form should be sent to [e-mail]