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Validation and Implementation of Human-Based New Methods in Regulatory Contexts

The BMBF funding programme supports collaborative international projects aimed at validating and implementing human-based New Approach Methods (NAMs) to reduce animal testing in regulatory evaluations of chemicals and pharmaceuticals. Projects should target either Module I (TRL 3-4) or Module II (TRL 5-7), focusing on toxicity or efficacy testing. Collaboration between academia, industry, and regulatory authorities is required, with mandatory international (Germany-Netherlands) consortia involving public and private partners. Submission requires consultation with regulatory bodies (mandatory for Module II).

Deadlines:

  • Opening Date: 06 January 2025
  • Submission Deadline: 28 April 2025

Important Conditions:

  • Minimum Technology Readiness Level (TRL): 3
  • Maximum Technology Readiness Level (TRL): 7
  • Projects must include at least one German and one Dutch partner
  • Consultation with relevant regulatory authorities obligatory for Module II
  • Results must be usable within Germany, EEA, Switzerland, and OECD member states

Expected Outcome

The programme aims to sustainably strengthen the translation of research results into healthcare, establish human-based NAMs in regulatory frameworks, reduce animal testing, enhance chemical safety, and contribute significantly to environmental protection. Validated methods should be internationally standardized and accepted by regulatory bodies, such as the OECD and EMA.

Scope

Funded projects will validate, standardize, and implement human-based NAMs with an interdisciplinary approach. Examples include neurotoxicity, reproductive toxicity, endocrine disruptors, immunotoxicity, oral toxicity, immunogenicity, and inhalative sensitization. Projects should clearly demonstrate human relevance and potential to reduce animal testing, aiming for OECD regulatory acceptance within two years post-project.

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