Initiative 5.3. New Approach Methodologies

What is it about?

New Approach Methodologies (NAMs) refer to methods that do not involve live animals, such as in vitro or in silico approaches, as well as combinations of these. NAMs can complement or, in some instances, reduce or replace animal research models for biomedical research and regulatory testing, as well as for the assessment of the safety, efficacy, and quality of products.

This initiative includes the development, validation, acceptance and implementation of NAMs in biomedical research and regulatory testing of medicinal products and medical devices.

Goals & Key Activities

• Austria is participating in efforts towards a coordinated development, validation, acceptance and uptake of NAMs within the EU. The aim is to harmonise strategies for the development and implementation of NAMs, and to identify criteria for the application of NAMs.
• The development of NAMs is supported by the Austrian Science Fund's annual call for proposals for the funding of alternative methods to animal procedures. The call for proposals is intended to support innovative projects in the field of research and development of alternative methods to animal testing.
• Developing an overview and raising awareness of established NAMs and their field of application within the Austrian research community;
• Specific research infrastructure as well as special laboratories at universities or central research institutions in Austria offer services and know-how for the development and implementation of NAMs. A comprehensive overview in the form of a national catalogue is intended to provide the life sciences research community with the availability of NAMs, relevant research infrastructures and existing methods, thus facilitating the implementation of NAMs.

Who is involved?

• Austrian Federal Ministry of Women, Science and Research
• Austrian Federal Ministry of Agriculture and Forestry, Climate and Environmental Protection, Regions and Water Management
• Universities, research institutions and relevant companies
• Austrian National 3R Centre
• Austrian Institute of Technology (AIT)
• Austrian Science Fund (FWF)
• National Committee for the protection of animals used for scientific purposes
• European Society for Alternatives to Animal Testing (EUSAAT)

Expected impact

• NAM education and training, identifying the opportunities to better inform researchers and regulators on NAMs and on the application of the 3R-principle;
• Harmonised NAM openness and awareness, improving open access to NAM protocols;
• Increased public trust and societal acceptance of scientific innovation;
• Long-term expected impact includes the increased availability of NAMs that will in a first step complement, and in the long run reduce or replace, animal studies to accelerate progress in biomedical research and innovation.