EMA proposes new method to reduce animal drug testing

Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.

On 31 March, EMA's Committee for Medicinal Products for Human Use (CHMP) published the proposed qualification that specifically addresses the use of VCGs in non-clinical rat dose range finding (DRF) studies. The agency said their use could reduce the number of control animals used in studies or completely replace them in concurrent control groups.

"While the reduction of animal testing will be gradual, this first qualification opinion for a NAM used in the assessment of toxicity, creates a blueprint for future applications," said EMA. "Potential iterations of the NAM could be qualified for use in toxicological studies where control groups are routinely required.

"Replacing control groups with ‘virtual animals’ in such studies would have a substantial impact on reducing the total numbers of animals used," the agency added.

The VCGs are based on a database using the Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (SENDIG) standard called the Developing and implementing VIrtual Control groups To reducE animal use in toxicology Research (VICT3R) database. EMA emphasized that its qualification opinion applies only to VCGs intended to replace concurrent control groups, and that the population and composition of the VICT3R database are outside the scope of the document.

EMA also emphasized that marketing applicants who wish to use the VCG approach must provide assurance that the proposed method will not compromise study outcomes or human safety. The agency added that the objective of using VCGs in DRF studies is to inform researchers on dose selection for subsequent pivotal repeated dose studies by establishing a No Observed Adverse Effect Level (NOAEL) and identifying preliminary adverse findings.

Global harmonization

International regulators, including the EMA, often require animal studies for non-clinical safety assessments before researchers begin in-human testing in clinical studies and submit marketing applications. Typically, regulatory toxicology studies use 25% of the animals as controls, but that may change as researchers use VCGs.

"Virtual control groups are established by characterising control data and identifying appropriate ‘virtual comparator animals’ for treated animals," said EMA. "This is done in line with a standard operating procedure, using a statistical approach that is complemented by expert judgement.

"The qualification of virtual control groups marks a crucial first step towards reducing animal use in medicines testing," the agency added.

Broadly speaking, EMA said that use of NAMs promotes its commitment to replace, reduce, and refine (3R) the use of animals in medical research and regulation. The agency said it is also in line with the International Coalition of Medicines Regulatory Authorities (ICMRA), to encourage the development, validation and adoption of testing methods and strategies that reduce and replace the use of animals used in research.

"Through the integration of virtual control groups, EMA also seeks to improve the relevance and predictability of non-clinical testing, which supports both more efficient and more ethically responsible medicines development," said EMA.

"EMA supports the progressive integration of NAMs through various mechanisms, including qualification, with the aim of enabling their regulatory acceptance, fostering innovation and reducing reliance on animal testing while ensuring human and animal safety," the agency added.

Stakeholders can comment on EMA’s proposed qualification until 12 May by emailing the agency at [email protected].

The US Food and Drug Administration (FDA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) have both also recently issued guidance on using NAMs to reduce the need for animal testing in medical research.

Last week, MHRA published a guidance on how it plans to review clinical trial authorization applications of marketing authorization applications that use non-animal data. The agency said it will work to phase out animal testing as much as possible by helping product developers use NAMs. It also said that applicants using NAMs will be able to get more clarification from its reviewers on how such data can be used, ultimately giving them more confidence in their marketing applications. (RELATED: MHRA moves to reduce animal testing with new guidance, Regulatory Focus 25 March 2026)

MHRA's announcement came a week after FDA published a similar guidance intended to encourage drugmakers to rely less on animal studies and instead adopt NAMs. The agency's efforts are part of the mandate issued by Congress under the 2022 FDA Modernization Act 2.0, which explicitly states that NAMs can be used to support an Investigational New Drug (IND) application or a biosimilar biologics license application (BLA). (RELATED: FDA drafts guidance on animal testing alternatives, Regulatory Focus 18 March 2026)

EMA proposed qualification, EMA announcement