The European Medicines Agency (EMA) has issued a fresh blueprint on the use of new approach methodologies (NAMs) amid its efforts to phase out the use of animals in preclinical drug testing.
The draft qualification opinion, which the agency debuted on 31 March, acknowledges the virtual animal control as a scientifically valid source of evidence for a drug’s safety in the preclinical setting – provided it fits within the defined context of use.
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This means that companies looking to demonstrate the safety of their drug candidate at the preclinical stage can now phase out standard animal controls in exchange for this form of new approach methodology (NAM), which can be created by characterising control data and identifying suitable “virtual comparator animals” for treated models.
According to the regulator, the introduction of virtual control groups will also boost the “relevance and predictability” of preclinical testing protocols, while improving the process from an ethical standpoint.
To ensure that the implementation of such a method does not impact drug safety down the line, the EMA requires companies to provide that their use will not compromise study outcomes or threaten human safety in the clinical setting.
This shift in stance from the regulator ties in with its ongoing efforts to reduce the reliance of rats and other animals in dose-range finding and other preclinical studies.
According to the EMA, its qualification of virtual control groups as a valid method is “a crucial first step” towards diminishing the use of animals when testing therapies. While the agency acknowledges that phasing out animal testing will take time, it hopes this draft qualification opinion will have an impact on the overall number of animals used in the preclinical testing process.
The EMA is currently running a public consultation on the framework, which will be open to contributions until 12 May 2026.
Global regulators home in on NAMs
The EMA is not the only regulator to introduce new guidance around NAMs, as the US Food and Drug Administration (FDA) has taken several steps in recent months to encourage the use of NAMs in preclinical testing.
In December 2025, the FDA put out a draft guidance focused on non-human primates, which encourages sponsors to reduce or eliminate the use of these animals in toxicity studies – instead focusing on human-relevant models like computational assays, organoids and real-world data. Prior to that, the agency announced that AI models and lab-based systems would take priority over animal data, as they are “more effective and human-relevant”.
Most recently, the FDA laid out its expectations in this area, noting that companies must clearly define the purpose and suitability of an assay, as well as its reproducibility and reliability as a measure of toxicity.
The UK government has also taken similar steps in this direction by pouring £60m into phasing out animal testing in favour of NAM approaches.
Though most regulators are making moves towards the widespread implementation of NAMs, Steve Bulera, CVP and chief scientific officer for safety assessment and toxicology, at Charles River Laboratories, previously told Clinical Trials Arena that the sector has several hurdles to overcome before this becomes standard practice.
