EMA Seeks Opinion on Animals Used in Drug Development

The European Medicines Agency (EMA) announced on March 31, 2026 that it’s Committee for Medicinal Products for Human Use (CHMP) has issues a draft qualification opinion1 for a preclinical research methodology to reduce the use of animals in specific dose-range finding studies.2 The new approach method (NAM) would replace standard animal control groups with virtual groups, and once qualified, would allow CHMP to accept evidence generated from virtual control groups in medicine approval applications.

EMA states that reduction in animal testing will be gradual. The first qualification opinion for a NAM used in toxicity assessment will create a “blueprint” for future applications, and potential versions of the NAM could be qualified in the future for toxicological studies that require routine control groups. “Replacing control groups with ‘virtual animals’ in such studies would have a substantial impact on reducing the total numbers of animals used,” the agency stated in the press release.2

To create a virtual control group, control data are characterized, and appropriate virtual comparator animals are identified, in line with a standard operating procedure and a statistical approach complemented by expert judgement.

Why Use Virtual Control Groups?

The use of virtual control groups is part of EMA’s and the International Coalition of Medicines Regulatory Authorities’ commitment to replace, reduce, and refine the use of animals in the development and regulation of drugs. According to the agency, NAMs can contribute to these efforts, and the agency supports the integration of NAMs into various mechanisms to enable regulatory acceptance and foster innovation without the use of animals.

“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,” the agency stated in the release.2 “A key requirement for the implementation of virtual control groups is the assurance that their use does not compromise study outcomes or pose a threat to human safety in later clinical trials.”

Public consultation on the draft opinion is open from March 31 through May 12, 2026. Input from the scientific community and stakeholders can be sent to ScientificAdvice@ema.europa.eu using a template.

How Is FDA Making Similar Moves in the US?

On March 18, 2026, FDA issued a draft guidance document on how to validate NAMs to replace animal testing in drug development.3 The document provides recommendations for validating NAMs when nonclinical NAMs data are provided.4 Drug sponsors are required to submit nonclinical pharmacology and toxicology data before an investigational drug can go to clinical trial.

The guidance document established 4 validation principles:

• Context of use that provides a clear definition of the NAMs’ intended regulatory purpose
• Human biological relevance to demonstrate how NAMs can assess toxicity
• Technical characterization to establish scientific confidence through robust, reliable, and reproducible methods
• Fit-for-purpose to provide assurance that NAMs help in regulatory decision-making (eg, drug review and potential approval).

“Technological advances are allowing us to move beyond animal testing in drug development, which has a poor track record of predicting safety and efficacy in humans,” said FDA Commissioner Marty Makary, MD, MPH, in a press release.3 “This guidance will facilitate the adoption of modern alternatives to animal testing in regulatory submissions.”

References

1. Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies. EMA. March 31, 2026. Accessed April 1, 2026. https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-virtual-control-groups-vcg-replace-concurrent-control-groups-ccg-rat-non-glp-dose-range-finding-drf-studies_en.pdf
2. EMA consults on virtual control groups to help reduce animal use in medicines development. EMA. Press release. March 31, 2026. Accessed April 1, 2026. https://www.ema.europa.eu/en/news/ema-consults-virtual-control-groups-help-reduce-animal-use-medicines-development
3. FDA releases draft guidance on alternatives to animal testing in drug development. FDA. Press release. March 18, 2026. Accessed April 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-alternatives-animal-testing-drug-development
4. General considerations for the use of new approach methodologies in drug development. Draft guidance. FDA. March 19, 2026. Accessed April 1, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development