The VICT3R project has reached an important milestone in the qualification of the Virtual Control Group (VCG) concept.
The European Medicines Agency (EMA) has issued a Qualification Opinion on VICT3R Context of Use I, which focuses on the application of VCGs in dose-range finding (DRF) non-GLP repeated dose toxicity rat studies.
The Qualification Opinion, adopted by the EMA Committee for Medicinal Products for Human Use (CHMP), represents a key step towards the regulatory acceptance of VCGs and data-driven approaches in toxicology.
The EMA Qualification Opinion concludes that:
“Based on the evidence presented by the Applicant and reviewed by the SAWP Qualification Team, CHMP considers that Virtual Control Groups (VCGs) can be used to substitute for Concurrent Control Groups (CCGs) ) in non-clinical non-GLP rat dose range finding (DRF) studies to inform on dose selection for subsequent pivotal rat GLP-compliant repeated dose studies, when applied in accordance to the SOP (see Appendix 1).”
The document is now open for public comments for a period of six weeks until 12/05/2026:
Following the consultation phase, EMA will review the feedback received and issue a final Qualification Opinion.
This achievement reflects the collective effort of the VICT3R community to date and provides further momentum as we continue our work towards the regulatory acceptance of the VCG concept.
More information here.
