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Event

New Approach Methodologies (NAMs): The Future of Regulatory Toxicology

5 min read

This week, the international scientific community has gathered in Maastricht for ESTIV 2026, the 23rd Congress of the European Society of Toxicology In Vitro (29 June – 2 July). The theme captures exactly where our field is heading: “Ensuring Safety, Advancing Science: Bridging to the Future with NAMs.”

GenEvolutioN is on site alongside our partner Xenometrix, and the conversation everyone is having is the same one that drives our laboratories every day: how do we assess chemical safety more accurately, more ethically, and in step with evolving regulation? The answer increasingly points to New Approach Methodologies (NAMs).

What are New Approach Methodologies (NAMs)?

“New Approach Methodologies” is the umbrella term for any technology or strategy that informs chemical hazard and risk assessment without relying on conventional animal testing. NAMs cover a broad and growing toolbox:

  • In vitro methods — cell- and tissue-based assays, reconstructed human models
  • In silico approaches — computational modelling, QSAR, read-across
  • In chemico methods — cell-free reactivity assays
  • Omics and high-content technologies that capture biological responses at scale

The common thread is human relevance. Rather than extrapolating from animal physiology, NAMs characterise how a substance behaves in human-relevant biological systems — often with a clearer mechanistic readout.

Why NAMs matter for regulatory safety assessment

The shift towards NAMs is driven by four converging forces.

An ethical mandate. The 3Rs principle — Replacement, Reduction and Refinement — has guided experimental science for decades and is now embedded in regulatory expectations worldwide.

A regulatory reality. In the European Union, the marketing of cosmetic products and ingredients tested on animals is fully prohibited, a landmark transition that pushed the cosmetics sector to adopt alternative methods at scale. Frameworks such as REACH and ICH guidelines continue to expand the role of non-animal data across chemicals and pharmaceuticals.

Scientific maturity. Many NAMs are now formally validated and adopted as OECD Test Guidelines, giving them genuine regulatory standing.

Speed and cost. Well-designed in vitro and in silico strategies can shorten development timelines and reduce cost, supporting a faster, better-informed time to market.

Highlights

NAMs cover in vitro, in silico, in chemico and omics approaches — not a single technique, but a coordinated toolbox
Their defining strength is human relevance and mechanistic insight, not just animal replacement
Regulatory acceptance is accelerating through validated OECD Test Guidelines and integrated assessment frameworks
NGRA, IATA and Defined Approaches turn individual assays into robust, submission-ready conclusions

From single assays to integrated approaches

The most important evolution is not any individual test — it is how results are combined. Modern safety assessment increasingly relies on integrated strategies that weigh multiple lines of evidence:

  • NGRA (Next-Generation Risk Assessment) — an exposure-led, hypothesis-driven framework that integrates NAM data to reach a protective safety decision without a single definitive animal study.
  • IATA (Integrated Approaches to Testing and Assessment) and Defined Approaches — structured ways to combine assays into a transparent, defensible conclusion.
  • Adverse Outcome Pathways (AOPs) — mechanistic maps that connect an initial molecular event to a final health outcome, anchoring each assay in biological meaning.

This is where in vitro toxicology becomes genuinely predictive: by understanding mechanism, not only observing an effect.

Key figures

50+

years of scientific heritage

GLP

accredited regulatory testing

ISO

17025 & 10993 dual accreditation

NAMs in practice at GenEvolutioN

As a GLP-accredited contract research organisation specialising in regulatory in vitro toxicology, GenEvolutioN works at the operational edge of this transition. Our portfolio is built around endpoints where NAMs already deliver regulatory-grade data:

  • Genotoxicity — including micronucleus approaches and mechanistic readouts that help distinguish clastogenic, aneugenic and cytotoxic events
  • Phototoxicity
  • Skin sensitisation
  • Dermal permeation
  • Analytical chemistry in support of robust study design

Operating under GLP, ISO 17025 and ISO 10993, we help pharmaceutical, chemical and cosmetic clients translate NAM science into data that holds up to regulatory scrutiny.

GenEvolutioN and Xenometrix at ESTIV 2026

Our presence in Maastricht alongside Xenometrix reflects the very spirit of ESTIV 2026: building bridges between technologies, sectors and partners to advance non-animal science. It also marks another step in a growing collaboration centred on bringing validated NAMs to the clients who need them.

If you are attending the congress, we would be glad to discuss how NAM-based strategies can strengthen your regulatory dossiers.

Frequently asked questions

New Approach Methodologies (NAMs) — common questions

What does NAMs stand for?
NAMs stands for New Approach Methodologies — a broad term for in vitro, in silico, in chemico and omics-based methods used to assess chemical safety without conventional animal testing.
Are NAMs accepted by regulators?
Yes, increasingly so. Many NAMs are formally validated and adopted as OECD Test Guidelines, and frameworks such as NGRA and IATA are designed to integrate NAM data into regulatory decisions. Acceptance depends on the endpoint and jurisdiction.
Can NAMs fully replace animal testing?
For several endpoints — and entire sectors such as cosmetics in the EU — non-animal approaches are already the standard. For more complex systemic endpoints, integrated strategies continue to mature towards full replacement.
How does GenEvolutioN apply NAMs?
As a GLP-accredited CRO in regulatory in vitro toxicology, GenEvolutioN delivers NAM-based data across genotoxicity, phototoxicity, skin sensitisation and dermal permeation, supported by analytical chemistry for submission-ready dossiers.

Talk to our team about your in vitro toxicology and NAM strategy → Book a call