EMA publishes draft qualification opinion on Virtual Control Groups (VCG) for rat studies

The proposal marks the first qualification opinion for a New Approach Methodology (NAM) in toxicity assessment and represents a significant step toward reducing animal use in medicines development.

VCGs use historical control data combined with statistical methods and expert judgement to create virtual comparators, offering the potential to replace live control animals without compromising study quality or regulatory decision-making. If ultimately qualified, the methodology could be accepted in future regulatory submissions within its defined context of use.

According to the EMA, the initiative supports the 3Rs principles—Replacement, Reduction and Refinement of animal use—and could serve as a blueprint for expanding virtual control approaches to additional toxicology studies in the future. The draft opinion is open for public consultation before final adoption.

Read the full document – Link

Further information:

1. Standard Operating Procedure for the Implementation of Virtual Control Groups in Preclinical Studies – LINK
2. CHMP Scientific advice – LINK