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EMA publishes Revision 2 of VICH GL49 on residue depletion study method validation

🇪🇺 EMA · Fri 13 Nov 2026

The revised guideline covers validation of analytical methods used in residue depletion studies for veterinary drugs in food-producing animals; the changes from the previous version are not stated.

The European Medicines Agency has published Revision 2 of VICH GL49, the guideline on validating analytical methods used in residue depletion studies for veterinary medicines in food-producing animals. The document was listed on 13 November 2026.

The guideline belongs to the VICH series on studies evaluating the metabolism and residue kinetics of veterinary drugs in food-producing animals. Its specific subject is the validation of the analytical methods that generate data in residue depletion studies.

The information available does not say what has changed from the previous version, and the full text was not available for this report. Readers should consult the revised guideline directly to identify any amendments.

As general context, residue depletion data are used to support the setting of maximum residue limits (MRLs) and withdrawal periods for veterinary medicines used in animals intended for food production. Sponsors of such studies are therefore the main audience for the guideline.

What it means for your team

  • Sponsors and laboratories running veterinary residue depletion studies should obtain Revision 2 and compare it with the version they currently follow.
  • Teams should check whether any change affects analytical method validation plans for ongoing or planned studies supporting MRL and withdrawal period determinations.
  • The scope of the revision is not stated in the available information, so no conclusions about its impact should be drawn until the text has been reviewed.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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