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EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.
The European Medicines Agency (EMA) is encouraging the use of new approach methodologies (NAMs) as an alternative to animal testing in the assessment of safety and efficacy of new medicines during non-clinical development (1). In the European Union (plus Norway), 8.48 million uses of animals for scientific purposes occurred in 2022 (2). In most countries, the use of animals for some safety tests is required. For instance, Directive 2010/63/EU requires marketing authorisation holders to integrate the 3Rs (replacement, reduction, refinement) and welfare standards for the treatment of animals in all aspects of the development, manufacture, and testing of medicines (3). In October 2023, EMA published a concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs testing approaches (4). Such alternative methods as NAMs can be highly effective at modelling individual aspects of safety and efficacy and should help to reduce and/or replace animal testing in line with the 3Rs principles (5). These principles include:
NAMs will need to be phased in. EMA is working with NAM developers to facilitate regulatory acceptance of these methodologies through briefing meetings and discussions with its Scientific Advice Working Party. Companies can also apply for the Committee for Medical Products for Human Use qualification of NAMs and voluntarily submit data generated from NAMs to the EMA; however, these data can be excluded from the regulatory decision-making process (Figure 1).
The European Federation of Pharmaceutical Industries and Associations (EFPIA) endorses EMA's actions and believes it is feasible to phase out animal testing, “providing there is cross-sector collaboration, robust funding and incentives, global harmonization and streamlined regulatory acceptance of nan-animal methods” (6). In June 2025, EFPIA published pharma-specific recommendations regarding the phasing out of animal testing for chemical safety assessment. These include:
NAMs encompass a range of techniques, such as high-throughput screening, in vitro (cell- and tissue-based) assays, and in silico modelling, often utilizing artificial intelligence and machine learning. NAMs focus on identifying changes in biological function that occur before outward symptoms, allowing for a more mechanistic understanding of the biomolecular interactions along the pathway toward harm (7). For instance, adverse outcome pathways (AOPs) enable tiered testing at multiple biological levels, increasing the overall predictive power and providing more accurate evidence-based approaches for hazard and risk assessment (Figure 2). AOPs could potentially reduce the levels of drug attrition rates resulting from undesired effects later in product development (8–10).
Furthermore, some organoids, organ-on-a-chip (OOC) technologies, and multi-organ microphysiological systems can simulate native organ structure and function, providing a cost-effective and accurate model for pharmacokinetics, pharmacodynamics, and toxicity studies (11). OOCs allow the rapid screening of multiple drug development candidates on a single chip, improving regulatory safety assessments and reducing the number of animal-based screens (12). In addition, several in vitro cell biotransformation assays (CTAs) can assess carcinogenicity and exhibit good correlation with rodent bioassays. The CTAs can detect genotoxic and non-genotoxic carcinogens and provide a quick and more cost-effective alternative to in vivo carcinogen models (13). Large pharma companies, such as AstraZeneca, GSK, and Pfizer, have established partnerships with OOC and CTA companies to harness this technology in their preclinical drug development programmes (14–16).
There is a paradigm shift toward a more mechanistically driven approach to toxicity testing for safety assessment. During the past decade, significant progress has been made in the development and evaluation of AOPs, OOCs, and in silico modelling technologies that enable risk-free biomedical testing and reduce the need for animal-based models (2). Stakeholders will need to work together to phase in NAMs and phase out animal testing (6). The regulators are keen to embrace new methodologies that replace, reduce, or refine the use of animals in research and encourage NAM developers to share their data and knowledge to facilitate the regulatory acceptance of these methodologies and ensure the NAMs are scientifically sound and useful in regulatory decision-making for the future (1).
Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.