What’s Hot in 2026: New Approach Methodologies

Regulatory guidance is helping to drive greater acceptance of new approach methodologies that can reduce animal use and help improve outcomes of drug studies 

For years, I’ve contributed to the annual forecasts that Eureka, Charles River’s thought leadership platform, releases every December, providing readers with a glimpse of what’s to come in the new year. All were based on incredible scientific advances.  However, this year, I want to highlight the recent regulatory roadmap announcements regarding the increased use of New Approach Methodologies (NAMs) for pharmaceutical safety assessment. These methods are already leading to a reduction in animal use and are predicted to shorten the time required for new medicine development due to the use of human-relevant models.

This is a sea change in perspective for toxicology safety assessment, as reflected in responses from regulatory agencies. For instance, in April, the US Food and Drug Administration took the groundbreaking step to advance the development of therapeutic antibodies using non-animal methods and issued its draft guidance in December on using NAMS for testing mAbs. The European Medicines Agency’s reflection paper, released in November on the current regulatory testing requirements for medicinal products, encourages consideration of opportunities for implementing the 3Rs. Also in November, the UK Government signaled the use of NAMs for safety and highlighted the importance of validation and qualification, as well as steps to accelerate regulatory confidence. NAMs-based methods are already part of the toolbox for developing new medicines; these regulatory announcements shed light on their current use as well as the requirement to increase their use when scientifically justified to accelerate the development of new medicines that are both effective and safe. 

- Mary McElroy, PhD, MBA, Head, Discovery Pharmacology and Toxicology