The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recently issued a draft qualification opinion for a method to replace concurrent control groups with virtual control groups in dose-range finding non-GLP repeat-dose toxicology studies in the rat. Information and links to this draft, entitled “Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies”, are provided on the EMA website. The deadline to provide comments to the EMA on this draft is May 11th, 2026.
The Society of Toxicologic Pathology (STP) is preparing a list of comments to this draft opinion. The response will be coordinated and drafted by the Virtual Control Group Working Group of the Scientific and Regulatory Policy Committee (SRPC), led by Drs. Kirstin Barnhart and Brad Bolon. This working group has authored a draft Points-to-Consider manuscript on this topic, which is currently in review and will be published in Toxicologic Pathology by the end of the year. A few key points from this Points-to-Consider manuscript will be extracted by the Working Group leadership and approved by the Executive Committee to serve as an STP response to the EMA.
Additionally, a webinar entitled “Reducing Animal Use in Preclinical Toxicity/Safety Studies: Virtual Controls and Alternative Approaches", was held on April 23rd to delve deeper into the progress in industry on the use of virtual controls in nonclinical toxicity studies. View Recording
We encourage all STP members to review this important EMA draft opinion and consider providing feedback to the EMA directly as an independent scientist and/or on behalf of your employer/institution. A link to the EMA website for submission of comments is provided here.