The European Medicines Agency’s (EMA) human medicines committee (CHMP) has taken a landmark step towards reducing animal testing by issuing a draft qualification opinion for a new preclinical research method. 

 

The approach, which could significantly reduce the number of rats used in certain dose-range finding studies, replaces standard animal control groups with “virtual control groups.”

 

By qualifying this new approach methodology (NAM), the CHMP “can accept evidence generated using virtual control groups (within the defined context of use) as scientifically valid in future medicines applications.”

 

While the reduction in animal testing will be gradual, the CHMP said this first qualification opinion “creates a blueprint for future applications.” Future iterations could see NAMs applied to toxicological studies where control groups are typically required, meaning “replacing control groups with ‘virtual animals’ in such studies would have a substantial impact on reducing the total numbers of animals used.”

 

Virtual control groups work by characterising control data and identifying appropriate “virtual comparator animals” for treated animals, following a standard operating procedure that combines statistical methods with expert judgment.

 

The qualification of virtual control groups marks a “crucial first step towards reducing animal use in medicines testing.”

 

The EMA emphasized that innovative NAMs like virtual control groups support the agency’s commitment to the 3Rs principles – “to replace, reduce and refine the use of animals in medicines development and regulation.” They also align with international efforts by the International Coalition of Medicines Regulatory Authorities (ICMRA) to encourage testing methods that reduce or replace animal use.

 

Through virtual control groups, EMA aims to “improve the relevance and predictability of non-clinical testing, which supports both more efficient and more ethically responsible medicines development.” The agency stressed that a key requirement is ensuring “their use does not compromise study outcomes or pose a threat to human safety in later clinical trials.”