New Approach Methodologies
NAMs
A synchronised global shift in safety standards transcends the pharmaceutical landscape, as NAMs become the trusted default for drug safety decision-making.
Toxicology teams in the UK, EU, and US are now being challenged by their respective regulators to ask:
“Which combination of AI, computational models, and in silico platforms can prove this compound is safe?”
Here is your complete guide to understanding what NAMs are and why they’re urgent.
Contents
Updated for 2026 FDA CDER, UKCVAM, and ECHA/REACH requirements.
Practical implications for pharma
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UK Roadmap
UK Government commit to hard deadlines for integration of UKCVAM validated NAMs
Will your safety assessment testing protocols be approved?
The UK Government’s roadmap to phase out animal testing targets a new, evolving compliance requirement to deploy proven new approach methodologies (NAMs) in place of in vivo and other animal-based assays.
The much anticipated UKCVAM will establish a governance and oversight of standard, validated methods for carrying out non-animal safety assessments and other studies. They will introduce standardised protocols for industry, and deliver the most relevant tools to support regulators.
With this pharmaceutical testing standards and regulatory frameworks, including those established by the VICH, ICH, and OECD, are already considering alternative methods in their recommendations.
FDA Year One Progress
US accelerate alternatives with FDA roadmap mandating NAMs integration
Looking to derisk your Investigational New Drug (IND) filing?
The FDA launched a modernised nonclinical framework in 2025, which has already fundamentally shifted compliance expectations by moving past abstract planning into active, mandatory NAM integration for drug pipelines.
The ISTAND (Innovative Science and Technology Approaches for New Drugs) program detailed in the FDA roadmap, is now an established gateway for formal acceptance of NAMs, pinpointing where nonclinical alternative methods are acceptable and expected to replace legacy mammalian models.
The FDA is working closely with international harmonisation bodies to align global guidelines. These efforts with the EMA (Europe), DfR (Germany), PMDA (Japan) and TGA (Australia) will expedite an international consensus that establishes alternatives as the modern baseline requirement for successful IND clearances in the US and beyond.
EU Commission Roadmap
EU legislation alignment spans chemical and pharmaceutical NAMs deadlines
Could your chemical safety data be rejected?
The Commission has committed to the introduction of binding legislative proposals by 2029, where the utilisation of validated, human-relevant NAMs is the definitive gateway to entering and maintaining market access.
EU agencies ECHA, EFSA, and EMA are working towards the Next-Generation Risk Assessment (NGRA) framework, overturning traditional toxicology, resulting in data rejection where legacy animal data is used when a validated computational or in vitro alternative exists.
Established exploratory spaces are allowing industry and regulators to co-qualify testing methods to reach the EU standard for new approach methodologies, ensuring seamless data compliance under REACH and ICH.
What's changed?
Global reality check
As well as increased funding and collaborative spaces, the UK, US and EU are prioritising data sharing frameworks and pushing ahead with hard deadlines for specific endpoints where predictive alternatives have already seen approved safety testing protocols. Examples include use cases such as skin sensitisation.
You must keep up with the strides regulators are making to validate and promote NAMs over preclinical in vivo studies. Here’s what’s changed:
Deadlines are in place. The transition to NAMs is no longer a future goal of the spanning pharmaceutical sector.
Instead, regulatory agencies are rolling out formal deadlines and frameworks to detail how we will reach a hard endpoint of animal testing in safety testing.
Preclinical strategies must include NAMs. Building a preclinical strategy on legacy animal models will actively lead to regulatory rejection.
Designing and starting a preclinical program with associated safety testing today will result in your IND hitting submissions when binding deadlines launch, from 2029 onwards.
Regulators are working with industry. Regulators (the FDA, EMA, ECHA) have opened up collaborative, confidential exploration spaces to seek validation.
Your competition is likely already talking with regulators in these spaces, bypassing the regulatory bottlenecks associated with NAMs instead of waiting for fully validated models to hit the market.
Traditional toxicology thresholds. NAMs are new investigational tools that differentiate species-specific toxicity thresholds from true, human safety risks.
Promising drug candidates no longer have to be shelved by species-specific toxicity anomalies alone. Drug pipelines can be re-evaluated for unnecessarily shelved candidates.
One-size-fits-all becomes Fit-for-Purpose and Context of Use. Backed by the FDA’s March 2026 draft guidance, standard preclinical protocols are being replaced by tailored ones.
Establishing validation now requires you to justify the human biological relevance of testing models relative to the drug’s specific mechanism of action.
Practical implications
Five point checklist for implementation
Investment
Allocate budget now to ensure you can reap the full benefits of early adoption of new approach methodologies in your pipeline.
Revise Strategy
Follow the early stage development of NAMs integration and build ‘weight of evidence’ packages over previously defined animal studies.
Evidence Generation
Concentrate on generating robust scientific evidence for reliable NAMs validation and work closely with exploratory spaces.
Partner Selection
Choose partners with validated NAM expertise and experience generating data that meets regulatory expectations.
Competitive Positioning
Adopt NAMs early to improve development efficiency, avoid regulatory rejections, and quickly identify promising candidates.
You should begin to implement these practical process changes now, to reflect the below timeline:
April 2025
US FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies
November 2025
UK Strategic Roadmap for Replacing Animal Testing in Scientific Research, backed by £75 million in funding
March 2026
FDA Draft Guidance 'General Considerations for the Use of New Approach Methodologies in Drug Development' introducing Fit for Purpose and Context of Use frameworks
June 2026
European Commission Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments, spanning 22 concrete actions and 15 legislative domains
Late 2026
UK's hard deadline for halting the use of animals for skin and eye irritation tests
Late 2026
Formation of the UKCVAM, structured with direct input from the US (ICCVAM) and EU (ECVAM) validation counterparts
Mid 2027
UK hard deadline for terminating Botulinum Toxin bioassay
Mid 2027
UK, US and EU are bound to produce progress reports for their roadmaps
2028
UK forced swim test licenses to legally expire and banned sale of new licenses
December 2029
EU's legislative mandates will go live, as new proposals are submitted to replace animal data with validated in silico and in vitro models for prioritised endpoints
2035
Humanised in vitro and in silico models are the default global baseline inline with the US's EPA statutory deadline to eliminate mammalian testing endpoints
Risks of inaction
Why action on NAMs matters now
Choosing to pursue 2026 and 2027 with traditional toxicology testing models isn’t simply ‘sticking to what you know’, but it is actively creating a regulatory bottleneck in your approval process.
You must keep up with the strides regulators are making to validate and promote NAMs over preclinical in vivo studies.
For pharmaceutical organisations, the real consequence of inaction is not just that regulators will ask different questions in the future, but that competitors will also be making better-informed safety decisions earlier, reducing attrition, saving time, and generating stronger evidence for regulators and partners.
Understanding the crux of why the UK, EU, and US have published their roadmaps means recognising that a move towards modernising toxicology and adopting more predictive, mechanistic, and human-relevant approaches has already begun. With this, businesses should transition to meet the requirements of today’s science and next-generation pharmaceutical products.
The risk of inaction can span commercial, operational, and compliance disadvantages, both now and in the future:
Increased length of development timelines
Misalignment with the evolution of toxicology and reduced confidence in safety decisions
Lack of commercial advantage in a crowded landscape
Growing a NAMs Ecosystem
The transition to NAMs is being driven not by a single regulator, but by a coordinated ecosystem of regulatory agencies, scientific organisations, and international standard-setting bodies.
We’ve detailed some key players in the NAMs ecosystem to the right.
Working collaboratively to develop guidance, validation frameworks, and scientific evidence, each contribution will shape the future of regulatory-accepted NAMs.
Lhasa Limited recently hosted an industry roundtable. Discover how others in the market are responding to regulatory roadmaps in the whitepaper.
Local government engagement: