A new era of regulations

Global regulatory agencies are reaching unprecedented levels of alignment on the adoption of New Approach Methodologies such as Organ-Chips. Learn how these new policies are impacting the future of drug development.

OVERVIEW

Is phasing out animal testing by 2030 realistic?

On April 10, 2025, the FDA issued an announcement that they plan to phase out animal testing in 3-5 years. In their roadmap for achieving this goal, they specifically cited Organ-Chips as one of the New Approach Methodologies (NAMs) that could help get us there.

Since that announcement, several other global agencies have announced similar policies. Read on to learn the latest.

GLobal Regulatory Alignment

US Food & Drug Administration

The US FDA has a goal to phase out animal testing by 2030, starting with monoclonal antibodies and expanding from there. They have since followed up their announcement by publishing draft guidelines for reducing NHP usage.

National Institutes of Health

In July 2025, the NIH banned funding for new proposals that only feature animal-based experiments. They are also shifting their funding priorities to support more human-relevant methods.

UK Government

In November 2025, the UK Government announced a similar plan as the US FDA to phase out animal testing, with specific milestones and £75 million in new funding to help accomplish that goal.

US Environmental Protection Agency

In January 2026, the US EPA reaffirmed its commitment to phasing out animal testing by 2035.

European Medicines Agency

The EMA is expected to issue guidelines on the reduction of animal usage in preclinical research in early 2026.

Recognition by Global Regulatory Agencies

Emulate’s Organ-on-a-Chip technology has a strong track record with the world’s leading global regulatory agencies.

Used by 20+ global government and regulatory labs

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Multiple global agencies are actively using Emulate Organ-on-a-Chip technology in their research labs, including the US FDA, NIH, and Department of Defense, as well as the UK Health Security Agency and Germany’s Paul Ehrlich Institute.

On-track to become an
FDA-approved drug development tool

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As of February 2026, Emulate is the only Organ-Chip company in the final stage of the FDA’s ISTAND program. Pending successful completion of the qualification plan, the Emulate Liver-Chip S1 will be an FDA-approved drug development tool (DDT) for the detection of drug-induced liver injury (DILI) in IND submissions.

Sole Organ-Chip cited by US FDA and UK government

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Both the US and UK drug development regulatory agencies have announced plans to reduce the use of animals in preclinical research in favor of more human-relevant methods. In both of their published roadmaps for accomplishing that goal, Emulate was the only Organ-Chip company cited as a proof point of the technology’s readiness for providing more human-relevant data.

Regulatory Applications of Organ-Chips

AGENCY	ORGAN MODEL	PUBLICATION
US FDA	Brain	Modeling neurovascular dysfunction in Alzheimer's disease using an isogenic brain-chip model
	Liver	Utilization of a model hepatotoxic compound, diglycolic acid, to evaluate liver Organ-Chip performance and in vitro to in vivo concordance
	Liver	Co-Culture of Human Primary Hepatocytes and Nonparenchymal Liver Cells in the Emulate® Liver-Chip for the Study of Drug-Induced Liver Injury
	Liver	Challenges and Solutions in Measuring Commonly Used Biomarkers for Drug-Induced Liver Injury in a Liver-On-A-Chip Platform
	Lung	Assessment of drug permeability using a small airway microphysiological system
NIH	Liver	Liver quad culture chip as a model for radiation injury research
NIH	Liver	Developing an RNA Signature for Radiation Injury Using a Human Liver-on-a-Chip Model
US Department of Defense	Lung	Using Lung-Chip Technology to Characterize Emerging SARS-CoV-2 Variants
	Liver, Kidney	Development of Novel Modeling Approaches for Rapid Risk Characterization of PFAS and PFAS Alternatives
	Liver	A novel approach to interrogating the effects of chemical warfare agent exposure using organ-on-a-chip technology and multiomic analysis
	Intestine	Characterization of an engineered live bacterial therapeutic for the treatment of phenylketonuria in a human gut-on-a-chip
UK HSA	Lung	Infection of human alveolar MPS at high containment as a model for pandemic pathogens and assessment of medical countermeasures