NAMs News
AUG. 31 - SEPT. 04, 2026
NEWS, REPORTS & POSITION STATEMENTS
1. China’s CDE launches PIONEER Program to advance NAMs in drug development
China’s Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) on July 7, 2026 announced the launch of PIONEER — formally, “Propel Innovation and Operation of NAMs to Enhance Efficiency in R&D” — a structured five-year pilot initiative to advance the research, validation, and regulatory application of New Approach Methodologies (NAMs) in drug non-clinical evaluation as part of China’s effort to modernize non-clinical drug evaluation.
The agency opened a one-month public comment period on three foundational documents: an application guidance, an application form, and an implementation framework. The initiative is framed as a priority action under China’s 15th Five-Year Plan for pharmaceutical industry development. PIONEER establishes a formal channel through which drug developers and NAM technology developers can engage the CDE on the use of non-animal, human-biology-relevant methods, as part of non-clinical drug evaluation packages. The pilot is also intended to establish an “industry-academia-research- regulator” collaboration mechanism to jointly develop NAM technologies, validation standards, and regulatory science.
2. China: Animal testing exemption for perms, hair dyes & new-ingredient cosmetics is now law
China’s National Medical Products Administration (NMPA) has widened one of its most consequential regulatory pathways. Announcement No. 70 of 2026, dated July 28 and published July 29, takes effect immediately. This finalizes the draft NMPA circulated on March 31, 2026, and brands now have a concrete, operative framework to work with.
This expansion is one of eight measures in the announcement — and the one with the most direct impact on animal testing policy.
3. Impact of the FDA roadmap and perspectives for regulatory use of NAMs in Japanese pharmaceutical companies
The Japan Pharmaceutical Manufacturers Association (JPMA) conducted a survey of JPMA member companies in July 2025 to provide an overview of the status of NAMs in the Japanese pharmaceutical industry and to generate evidence for policy recommendations.
Shedding light on the impact of the FDA’s roadmap for reducing animal testing in nonclinical safety assessment, the results indicate strong interest in promoting the 3Rs and improving non-clinical development, but limited experience with NAMs, especially for regulatory applications. Both internationally harmonized guidelines and the establishment of a domestic qualification system, including early consultation channels and a transparent public database, are required to promote the regulatory use of NAMs in Japan. The JPMA could serve as a central hub by facilitating proactive communication among domestic and international stakeholders, thereby promoting the broader implementation of NAMs in regulatory submissions.
4. EFSA publication: How do we show that a NAM is ready for regulatory use?
A recent EFSA supporting publication proposes an implementation plan for qualifying NAMs. Central to this approach is the Context of Use (CoU). Importantly in this paper, regulatory value does not necessarily depend on the development of an OECD Test Guideline. Qualification can instead focus on the performance and scientific validity of a method for a defined application, potentially allowing suitable NAMs to be integrated into regulatory assessment through other routes.
The proposed approach reflects a broader effort to align regulatory science around the use of NAMs. The work involves experts from EFSA, OECD, ECHA, SCCS, EMA and EURL ECVAM and is closely connected to the development of Next Generation Risk Assessment (NGRA), including the integration of mechanistic data, in vitro approaches, PBK modelling and weight-of-evidence strategies. The implementation plan is currently open for public consultation until 31 October 2026. The consortium is also seeking external case studies.
Read the post by Sanghamitra Mishra, NexGenTox
5. NC3Rs impact report: Accelerating the use of non-animal reagents for in vitro research
The NC3Rs has published a new report describing the outputs and impacts of a funding call to support a shift away from animal-derived products to animal-free alternatives.
In 2024, the NC3Rs invested £905k to accelerate the adoption of animal-free products and reagents in in vitro research, as part of a package of £5M funding from the Department for Science, Innovation and Technology (DSIT). The targeted investment was designed to address key barriers to the uptake of animal-free products and reagents in order to build confidence in their use in routine research applications. Ten awards were funded for projects that included the evaluation of recombinant antibodies, chemically-defined media and synthetic matrices for routine cell culture studies.
Read more and download the report
6. Australia strengthens its momentum towards non-animal research
This summer, Bellberry and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists) released the draft of their NAMs HREC Review Checklist: a risk-proportionate, hybrid-model guide for Australian Human Research Ethics Committees for first-in-human trials supported by NAMs. The draft guidance was open for comment until 31 August.
According to consultant Michael Phelan, “This is not another policy statement about the promise of NAMs. It is the first practical framework published from any jurisdiction in the world. It tells review committees exactly how to interpret and scrutinise a NAMs-supported first-in-human trial application”.
Read more on Bellberry website
7. Why traceability will make or break the organoid revolution
The 3D cell model revolution, encompassing spheroids, organoids, microphysiological systems (MPS), and organ-on-chip technologies, has generated extraordinary momentum. Multiple platform technologies are now commercially available. Funding priorities are shifting. In the United States, the National Institutes of Health (NIH) announced in 2025 that it would no longer issue funding opportunities exclusively supporting animal models, signalling that new proposals must incorporate human-relevant alternatives. Demand for such models is accelerating on every front.
Yet the field faces an important foundational challenge. The scientific community does not yet have the standardised, traceable, end-to-end infrastructure needed to ensure that findings from one laboratory can be reliably reproduced in another. Until that gap is closed, the full promise of organoid-based science cannot be realised.
Read more in Drug Discovery World
INTERVIEWS, NOMINATIONS & AWARDS
8. CSCI to lead new £20m MRC Hub to transform development of new medicines using stem cells and AI
The Medical Research Council (MRC) has announced a £20 million investment in a new Pre-clinical Translational Models Hub, led by the Cambridge Stem Cell Institute (CSCI), which will transform the development and testing of new medicines by advancing the use of human-based models and artificial intelligence (AI).
The Hub will bring together expertise in advanced human in vitro models, including organoids and other stem cell-derived systems, AI-powered approaches, bioengineering and clinical research to create more accurate and predictive ways of studying human disease and evaluating potential treatments before they reach patients. The Hub will launch in November 2026, and will be led by Professor Matthias Zilbauer, Group Leader at the CSCI and Honorary Consultant Paediatric Gastroenterologist at Cambridge University Hospitals, and Professor Bertie Göttgens, Director of the CSCI.
Read the announcement by Bertie Gottgens
9. Interview with Dr Clive Roper: Why 90% of drugs fail
Despite remarkable advances in medicine, nearly 90% of drug candidates never make it to patients. Why does this happen — and how can we build a better path forward?
In episode 4 of 3DCC Platform Conversation, Dr. Clive Roper, Director, Roper Toxicology Consulting Limited, an internationally recognised expert in toxicology and NAMs, explores the limitations of traditional preclinical testing and discusses how human-relevant models are transforming the way we evaluate the safety and efficacy of new therapies.
TOOLS, PLATFORMS, CALLS
10. Contribute to the WC14 Program
The 14th World Congress on Alternatives and Animal Use in the Life Sciences (WC14) will be held in Seoul, Korea, from 15 – 19 August 2027. Under the congress theme, “Beyond New Frontiers: Innovation in New Approach Methods Using Life Sciences”, WC14 will bring together leading scientists, regulators, policymakers, industry experts, NGOs, and young researchers from around the world.
Be the catalyst of change and shape tomorrow’s future with your contribution! Present groundbreaking research, showcase visionary projects, and drive dynamic discussions in the Scientific Program of the Congress.
11. NAMina’s new tool to build human-relevant preclinical programs
NAMina Bio Corp. has opened the first public version of NAMina Program Builder™, a modular tool designed to help build human-relevant preclinical programs around the biological decision that needs to be addressed. Rather than starting from a specific technology, the approach begins with the scientific question and progressively connects biological context, human-relevant models, experimental conditions, functional and multi-omics readouts, analytical layers and evidence objectives.
The first public version is intended to gather feedback from scientists and biotech teams, while the underlying architecture is being progressively developed and validated.
Read the announcement by Paola Dama, Founder of NAMina Bio Corp
INDUSTRY, BIOTECH & PARTNERSHIPS
12. Bruker Corporation made majority investment in MIMETAS
Leader of the Post-Genomic Era, Bruker’s investment expands its post-genomic solutions for disease biology research, as well as for drug discovery and development into MPS, also referred to as NAM, and based on human physiology-relevant model systems.
“Human physiology-relevant tissue and disease models are becoming increasingly important for understanding disease biology and evaluating therapeutic candidates,” said Frank H. Laukien, President and CEO of Bruker Corporation. “The unique MIMETAS organ-on-a-chip platforms complement Bruker’s capabilities in multiomics, spatial biology and preclinical imaging. We believe that humanized Microphysiological Systems, or NAMs, have a bright future, and will be increasingly adopted in drug discovery, development and preclinical testing.”
SCIENTIFIC DISCOVERIES & PROTOCOLS
13. A ‘renaissance for biomedicine’: Human brain organoids record the passage of time over 5 years
In a new study published Aug. 19 in Nature, researchers from Harvard University show that a brain organoid, derived from a vial of blood, is able to record the passage of time and remain alive in a dish for five years.
Over the five years that these brain organoids were kept alive, the researchers optimized growth conditions to extend excitatory neuron viability beyond previous limits. Using maturation-associated modules derived from endogenous human brain, they show that brain organoids transcriptionally age with cell type specificity over years in culture. Whole-genome methylation profiling reveals that the predicted epigenomic age of organoids correlates precisely with time spent in vitro, and parallels epigenomic ageing in vivo. “For biomedicine, we might see a renaissance of new therapies that will emerge, where for decades and decades, nothing worked.” said Paola Arlotta, professor of stem cell and regenerative biology at Harvard University and corresponding author, in an interview with Fierce Biotech.
14. Brain organoids in Alzheimer disease and related tauopathies: Challenges and opportunities for translational readiness
A major hurdle in Alzheimer disease research is the failure of mouse models to capture complexities of the human brain that contributes to repeated clinical trial failure. Although the recent US Food and Drug Administration (FDA) Modernization Act 2.0 has enabled non-animal preclinical pathways, brain organoid models of tauopathies remain nascent compared with other disease areas.
In a recent article, researchers identify three challenges for their translational readiness, maturity, disease-relevant cellular complexity, and pathological accuracy, and examine current achievements and emerging solutions. They propose a ten-metric benchmarking framework and discuss the opportunities and remaining challenges for translational readiness in tauopathy modeling.
Read more in Stem Cell Reports
15. Human organ models for pandemic research
The COVID-19 pandemic created a unique situation in which researchers repurposed human models of varying complexity to investigate SARS-CoV‑2, providing the opportunity to analyse their contribution across organs. Researchers conducted a systematic review of 558 studies, divided into pandemic and post-pandemic periods, to assess how human models were applied to investigate host factors, viral replication of SARS-CoV‑2, immune responses, and to evaluate reporting quality.
By synthesizing the available evidence, the review identifies current strengths and limitations of the field and formulates seven recommendations to improve reproducibility, comparability, and translational relevance of human organ models for future pandemic research. The study was supported by Einstein Foundation Berlin; Federal Ministry of Research, Technology and Space; European Union; Else Kröner-Fresenius-Stiftung; Volkswagen Foundation; Charité 3R; Foundation Charité.
Read the article in eBioMedicine
16. External validity for in vitro toxicity studies: An important but challenging concept
When assessing whether chemical exposures are causing adverse health outcomes, or when making regulatory decisions informed by toxicity testing studies, it is essential to place the most weight on the most valid evidence. In a new paper, researchers present an operational conceptualisation of external validity for in vitro studies, to support the development of the forthcoming INVITES-EX tool.
They define external validity as consisting of a concept of applicability and a concept of generalisability, and explain how it applies to in vitro comparative effect size studies. The authors argue that external validity assessment is relevant at two stages of evidence synthesis, during study screening and during evidence integration. Because evidence integration is complex and likely best supported by guidance, they conclude that INVITES-EX should be targeted at assessing the applicability of individual studies and used when screening studies for inclusion in a systematic review or chemical assessment.
Read the article in Regulatory Toxicology and Pharmacology
WORTH (RE)SHARING — Summer edition
OECD releases 2026 NAMs test guideline updates, Eryn Slankster-Schmierer, ICAPO
On July 2026, the US House of Representatives passed the FDA Modernization Act 3.0
Report “Advancing Drug Development by Reducing Reliance on Animal Testing”, Reagan Udall Foundation for the FDA
“Need for NAMs: A systematic evidence synthesis revealing over half a century of drug development failure”, Tamara Zietek & al., NAM Journal
“Introduction to the 3RsC’s cross-platform microphysiological systems evaluation for drug-induced liver injury in collaboration with FDA-CDER”, LaFollette et al., Regulatory Toxicology and Pharmacology
“The Experiment Is Over. The Ethical Responsibility Is Not”, Damien Huzard, Founder, NeuroNautix
Novo Nordisk and AWS partner to accelerate AI-driven drug discovery
“Democratizing Organoids: Building Trust and Scientific Reproducibility through End-to-End Traceability”, Carolina Lucchesi, BioCompare
Biobank of patient-derived HepatocellularCarcinoma (HCC) organoids generated from diagnostic biopsies, Nuciforo et al., Cell reports
“How Online NAM Platforms Are Changing Toxicity Testing”, Kinga Nimz et al., JHU Toxicology Policy Lab
UPCOMING WEBINARS, WORKSHOPS, SYMPOSIA
Presentation of the call for proposals “Demonstrating the value of organoids and organs-on-chips” – 07 Sept. 2026 – 10h00 — 11h00, online (in French)
3RsC Bone Marrow MPS Webinar – 09 Sept. 2026 – 16h00 — 17h00, online
Inside the Organoid Services Ecosystem for Drug Discovery Webinar – 09 Sept. 2026 – 16h00 — 17h00, online
Mini-Symposium #2 on NAMs for Preclinical HIV Research – 10 Sept. 2026, 11h45 — 16h30 (EDT), online
Advancing NAMs Together: An Interactive Exchange of Insights & Expertise – 10 Sept. 2026, 1:00 PM — 2:30 PM (EDT), online
Novel Alternative Methods in Basic Mechanisms of Brain Aging and AD/ADRD – 10 – 11 Sept. 2026 – 11h00 — 15h30 (ET), online
EUROTOX 2026 – 13 – 16 Sept. 2026, Vienna (Austria)
