Coordination of efforts under Complement-ARIE
In 2023, NIH approved the Complement Animal Research in Experimentation (Complement-ARIE) program concept to accelerate the development, validation, and adoption of NAMs, especially those that combine different approaches to more accurately model human biology and diseases. Complement-ARIE is an NIH-wide effort, involving 23 Institutes, Centers, and Offices, and was developed with input from eight federal agencies. U.S. federal agencies participating in Complement-ARIE activities include:
- U.S. Department of Health and Human Services
- Advanced Research Project Agency-Health
- Biomedical Advanced Research and Development Authority
- National Institutes of Health
- Defense Threat Reduction Agency (U.S. Department of War)
- U.S. Environmental Protection Agency
- U.S. Food and Drug Administration
- National Aeronautics and Space Administration
- National Institute of Standards and Technology
- U.S. Department of Agriculture
- U.S. Department of Veterans Affairs
In 2025, EPA and FDA formalized their participation in Complement-ARIE through Memoranda of Understanding. Activities that will be facilitated and conducted under these agreements include providing regulatory expertise from EPA and FDA to support, refine, and advance Complement-ARIE projects, and the convening of joint workshops to support progress and develop new initiatives. A number of governmental, international governmental, nongovernmental organizations, and private companies are participating in the Complement-ARIE Validation and Qualification Network, a public-private-partnership managed by the Foundation for NIH to accelerate the regulatory approval and deployment of NAMs for biomedical research. The network includes 20 public partners, with representatives from the European Union, United Kingdom, and Japan, as well as over 40 private sector partners. Partner organizations provide scientific and regulatory expertise to develop projects within the Complement-ARIE Validation and Qualification Network.