Medical research saw a tectonic shift in 2025.
The promise of New Approach Methodologies (NAMs) to improve human health and replace animals in drug testing is no longer hypothetical. Global governments took notice and acted.
In 2025:
- The US released the groundbreaking “Roadmap to Reducing Animal Testing in Preclinical Safety Studies”
- The UK released its roadmap, “Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods”
- The CDC announced the elimination of primate testing in their facilities
- A record number of technologies were accepted into the FDA ISTAND program
2026 promises to deliver even more NAMs bombshells.
We are likely to see new government initiatives, a multitude of new and updated guidance documents, and dozens of groundbreaking new technologies.
However, there are three key items I’ll be keeping an eye out for in 2026:
The EU’s Roadmap
One of the most hotly anticipated items in 2026 is the promised European Commission’s “Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments”. Publication is anticipated in Q1. This publication is expected to outline Europe’s plan to phase out animal experimentation for all chemical substances, including pharmaceuticals* (relevant to the EMA).
Together, the FDA and EMA account for over 70% of novel drugs approved globally. The two roadmaps, published less than 12 months apart, will clearly outline how animal testing will be phased out of regulatory approval of drugs.
One of the major outstanding questions will be, “how aggressively will Europe pursue the elimination of animal testing?” Historically, this objective has always been pursued conservatively, but with added pressure from the US and UK, the EU might choose to move faster. This document gives the EU the opportunity to become the global leader in NAMs adoption.
US NAMs Legislation
The FDA Modernization Act 3.0 is a very short and simple bill. It identifies 22 locations in the existing Code of Federal Regulations pertaining to the FDA (21 CFR) that reference animal testing and require this language be replaced with “nonclinical” tests. This primarily impacts 21 CFR 312 (IND Applications), 314 (New Drug Applications) and 601 (Biologics License Applications). The FDA Modernization Act 3.0 has passed the Senate and its companion measure is waiting on a floor vote in the House. While not guaranteed, a House vote is expected in 2026. Bipartisan support suggests it would be passed and signed.
As written, this change seems small. However, its impact could be extraordinary. This small tweak from the word “animal” to “nonclinical” in IND, NDA, and BLA applications formally opens the door for truly animal-free drugs to be approved by the FDA.
ISTAND Progress
The first technology accepted into the FDA ISTAND program to qualify new technologies was Integral Molecular’s Membrane Proteome Array (MPA). Integral Molecular has since had their Qualification Plan accepted and then submitted their Full Qualification Package (the final stage) in 2025. As the first FQP to be reviewed, there is no definite timeline for acceptance. But, Integral Molecular’s QP review took just under 17 months and ISTAND timelines have been accelerating. If the FQP is considered acceptable and the review can be completed in under 15 months, 2026 will show the first technology to ever complete the program.
This acceptance will have profound consequences. Acceptance will set the standard for future technologies to be accepted. It will enable other technologies’ reviews to move faster. Most importantly, it will allow drug developers to include ISTAND-approved technologies in INDs within the framework of an approved Context of Use (COU). This could profoundly alter the preclinical strategies of global drug developers.
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[…] flurry of attention New Approach Methodologies (NAMs) have recently received has come with a range of ambitious […]
[…] past 12 months have shown an incredible focus on New Approach Methodologies (NAMs) to reduce our reliance on animals and incorporate human-relevant biology into drug development and […]
[…] Momentum behind New Approach Methodologies (NAMs) has accelerated rapidly in recent years. Regulators, industry, and academia are investing heavily in human-relevant technologies such as organoids, microphysiological systems (MPS), other complex in vitro models, and computational models. […]