Regulation

TGA publishes its position on NAMs

Weight-of-evidence approach. NAMs may need to run alongside animal studies where uncertainty remains.

SystImmune reports IND clearance with a NAM-based safety package

Company says organ-on-chip and primary human tissue models replaced conventional animal toxicology for bispecific SI-B037. FDA has not commented publicly.

Emulate files full qualification package for Liver-Chip

Final step of three in ISTAND. If FDA qualifies it, it would be the first organ-chip drug development tool, for DILI assessment.

EPA announces changes to new chemical and pesticide reviews

Two changes aimed at modernizing safety reviews while reducing reliance on animal tests.

House passes FDA Modernization Act 3.0 (H.R. 2821)

Passed by voice vote and received in the Senate on Jul 21. The Senate must pass the House bill before it goes to the President. No final vote found as of this update.

NIH formally launches ORIVA

New office with two divisions: DAIBR for extramural NAM investment, and D-NICEATM, which absorbs NICEATM.

EPA updates its accepted NAMs list for TSCA and FIFRA

First update in five years. Adds 13 methods from external authoritative bodies and opens a nomination process.

EU roadmap to phase out animal testing in chemical safety assessments

22 actions and 30+ recommendations across 15 legislative domains, from industrial chemicals to pharmaceuticals, with indicators, a public dashboard and a 2029 review conference.

Draft guidance: oncology biologics and conjugates, streamlined nonclinical safety

Weight-of-evidence approach centered on three-month toxicology studies for certain oncology biologics and conjugated products.

C-Path launches NAMs Developer Coalition

Precompetitive coalition of NAM developers working with regulators on shared validation and qualification standards.

FDA Year One progress report on reducing animal testing

FDA says first-year goals were met: ISTAND made permanent, a NAMs acceptability database, and its first qualified AI drug development tool. Critics note animal studies remain the default starting point.

Draft guidance: General Considerations for the Use of NAMs in Drug Development

CDER validation framework built on context of use, human biological relevance, technical characterization and fit for purpose. Comments closed May 18, 2026.

Complement-ARIE first awards ($150M+)

Five NAM technology development centers, a NAMs data hub, a validation and qualification network with FNIH (about $20M), and a $7M challenge run with FDA and EPA.

Endotoxin testing Q&A update backs non-animal reagents

Updated pyrogen and endotoxin questions and answers supporting a shift away from horseshoe crab-derived reagents.

EPA recommits to ending mammalian testing by 2035

Administrator memo revives the 2035 goal first set in 2019 and rescinded in 2021.

Senate passes FDA Modernization Act 3.0 (S.355)

Passed by unanimous consent. Directs FDA to issue an interim final rule within one year replacing animal-specific language in its regulations with nonclinical language.

ARPA-H names CATALYST performer teams

Up to $125M over 4.5 years for AI and computational ADME-Tox models meant to support regulatory filings. Eight teams: Draper (with Revalia Bio), Deep Origin, Inductive Bio, Jackson Laboratory, Black Mesa Technology, Cedars-Sinai, Peptilogics and UNC Chapel Hill.

Draft guidance: monoclonal antibodies, streamlined nonclinical safety studies

Draft guidance to reduce or remove certain nonhuman primate studies for monoclonal antibodies.

UK strategy: Replacing animals in science

GBP 75M, a new validation center (UKCVAM) and dated targets: skin and eye irritation and skin sensitization tests replaced by end of 2026, Botox potency tests by 2027, fewer dog and primate PK studies by 2030.

Complement-ARIE Reduction to Practice Prize launched

Prize competition for NAMs that can show practical, real-world viability.

EMA qualification opinion for the Simcyp PBPK platform

First PBPK platform qualified for EU regulatory submissions, for defined CYP-mediated drug-drug interaction contexts of use.

NIH unified strategy on human-based NAMs

NIH restated its commitment to promote human-based methods and reduce animal use across its portfolio.

NIH stops issuing animal-only funding opportunities

NIH no longer releases funding opportunities focused exclusively on animal models.

NIH initiative to prioritize human-based research

NIH said it would create ORIVA and judge methods in funding applications on suitability, context of use, translatability and human relevance.

FDA roadmap to reduce animal testing in preclinical safety studies

Stepwise plan that starts with monoclonal antibodies and aims to make animal studies the exception within three to five years.

ISTAND accepts first organ-chip submission

FDA accepted Emulate's letter of intent for a Liver-Chip tool to assess drug-induced liver injury, the first of three qualification steps.

FDA Modernization Act 2.0 enacted

Removed the statutory requirement for animal testing before human trials. Nonclinical tests can now include cell-based assays, microphysiological systems and computer models.