Tox News: October 2026

The NC3Rs is playing a leading role in advancing the uptake of new approach methodologies (NAMs) for chemical and medicines safety assessment. Through our NAMs programme, which includes leading delivery of commitments in the UK Government's strategy on replacing animals in science, we are working with regulators, industry and researchers to support the practical implementation of these innovative approaches and strengthen their acceptance in regulatory frameworks. Over the past few months, we have shared our expertise at several international events and through invited publications that are helping to shape the future of NAM adoption.

New database to support the use of replacement approaches in regulatory safety assessment

We have launched a database of alternative methods and approaches to help identify opportunities for their use in regulatory safety assessment. This delivers a key part of Commitment 10 of the UK Government’s strategy on replacing animals in science. 

The list is initially being published as an Excel spreadsheet with a consultation period for version 1 open until 22 January 2027.

Recent publications

• In Nature Reviews Bioengineering, Dr Natalie Burden, Head of NAMs Strategy, explored opportunities for NAMs to reduce reliance on animal toxicity testing, highlighting the important role of bioengineers in ensuring NAMs are deployable, reliable and relevant to safety decision making.
• In Current Opinion in Toxicology, Dr Fiona Sewell, Head of Toxicology, examined the regulatory momentum for NAMs in medicines development, including insights from our joint NC3Rs/MHRA/ABPI workshop, which brought together regulators, industry and academia to explore practical approaches to NAM implementation.

Recent regulatory and scientific engagement

• NAMWISE workshop: Dr Amy Marriott, Programme Manager for Chemical Safety Assessment, contributed to discussions focused on building confidence in innovative approaches and developing case studies to support regulatory decision making at a stakeholder workshop of the EU-funded NAMWISE project.
• UK PARC Science Day: Natalie presented an update on progress towards accelerating NAM adoption for safety assessment as part of the UK Government’s strategy on replacing animals in science, at the UK Partnership for the Assessment of Risks from Chemicals (PARC) Science Day 2026.
• 3RCC/SCAHT Symposium: Fiona presented an overview of the UK perspective on translating the growing momentum for NAMs into practical implementation at the symposium co-organised by the Swiss 3R Competence Centre (3RCC) and the Swiss Centre for Applied Human Toxicology (SCAHT) on the validation of NAMs in toxicology.
• ApconiX Drug Safety Forum: Fiona delivered the keynote presentation at the ApconiX Drug Safety Forum 2026, discussing progress in implementing the UK Government's strategy on replacing animals in science and the role of the NC3Rs in supporting the uptake of NAMs.

In our latest blog Fiona discusses the importance of NC3Rs collaborations with the global toxicology community to find the balance between detecting potential risks of chemicals to human reproductive health while avoiding unnecessary suffering of rats and rabbits used in developmental and reproductive toxicity (DART) studies. With considerable differences in views about the workability of updated dose-setting advice from the European Chemicals Agency and concerns about the impacts on animals used, the NC3Rs is a leading voice in facilitating discussions to seek clarity and consensus to ensure chemicals are only tested at the lowest doses necessary to assure protection of human health.

Read more about our work on dose-level selection for DART studies.

Sunday 15 – Wednesday 18 November
San Antonio, Texas (USA)

If you are attending the American College of Toxicology (ACT) 47th Annual Meeting in San Antonio, visit us at booth #106 and join our session, Rethinking the ICH M3 two-species requirement: evidence for data-driven single-species approaches. The session will present findings from our collaborative data-sharing project exploring opportunities to reduce animal use in regulatory toxicity testing for pharmaceuticals, alongside interactive case studies demonstrating how single-species approaches could be applied in practice.

Read more on our work in challenging the routine use of two species in regulatory toxicity testing.

A recent publication in Frontiers in Toxicology, co-authored by Fiona, identifies practical opportunities to expand the responsible reuse of animals in toxicology studies and proposes a framework to support implementation. Reuse approaches have the potential to reduce the number of animals used and improve the sustainability of nonclinical safety assessment, without compromising scientific quality or animal welfare.

NAMs Technology Partn3Ring webinar series: Recordings available

Our six-part webinar series showcasing 27 innovative technologies with the potential to replace some animal use in toxicology and safety assessment from organisations across Europe, North America and Asia, is available to watch online. The series highlighted emerging approaches, shared insights from technology developers and fostered discussion on opportunities for collaboration and regulatory adoption.

In silico models to predict thyroid receptor-mediated endocrine disruption 

The Thyroid Tox CRACK IT Challenge funded by the NC3Rs has delivered two in silico models capable of identifying chemicals that may disrupt thyroid hormone signalling, reducing reliance on animal studies. With support from Shell and Syngenta as part of the Challenge, KREATiS have developed a QSAR model and a molecular docking tool, both now available as a service through KREATiS.

Accelerating the use of non-animal reagents for in vitro research

The latest NC3Rs impact report on Accelerating the use of non-animal reagents for in vitro research includes case studies on characterising engineered human heart tissue for use in cardiovascular research and safety assessment, evaluating an animal-free product protocol for the OECD Test Guideline 487 (the micronucleus assay) and optimising animal-free culture conditions for in vitro airway nanotoxicology.

The DRIVER recommendations: Improving the quality of in vitro research

We have recently launched the DRIVER recommendations, a new framework designed to improve the quality, reliability and reproducibility of research conducted using in vitro models. By promoting greater transparency and reporting standards, DRIVER aims to increase confidence in in vitro data, for example supporting the wider use and adoption of in vitro NAMs in regulatory decision making.

Rethinking the project license application and assessment process

Commissioned by the Home Office, we have reviewed how the principles of the 3Rs are incorporated into the current project licence application and assessment process, and published recommendations to improve both animal welfare and regulatory efficiency.

NC3Rs welfare webinar series

Our welfare webinar series showcases the latest evidence-based refinements for laboratory animals. Recent sessions include a focus on anaesthesia and analgesia for fish research (which can include studies used for ecotoxicology), alongside an upcoming webinar on refined drug administration methods.

EFSA Scientific opinion on waiving dog studies for agrochemicals

In July, the European Food Safety Authority (EFSA) published the Scientific Opinion on waiving of the dog studies in the regulatory process of agrochemicals approval, proposing a tiered, evidence-based approach to determine whether the 90-day dog study can be waived for a new active substance.

UK HSE online event: Avoiding vertebrate testing for biocidal products

Tuesday 3 November, 10.30 – 13.00 (GMT)

Delivered by regulatory specialists from Health and Safety Executive (HSE), this event will explore how to address toxicology information requirements for biocidal products without the use of vertebrate testing. 

The session is aimed at technical and regulatory professionals involved in the preparation and submission of data into the GB biocidal product authorisation process. Talks will explore how submissions are assessed by the GB regulator and opportunities to submit data from NAMs to assure human safety, replacing some tests involving rats, mice and rabbits.

HESI webinar on potential ICH S7A revision

Wednesday 4 November, 8.30 – 10.00 (EST)/13.30 – 15.00 (GMT)

The Health and Environmental Sciences Institute (HESI) are hosting a public webinar to discuss priorities for a potential revision of the ICH S7A guideline for safety pharmacology studies, including opportunities to integrate NAMs into safety assessment and promote the reduction and refinement of animal use.