Regional Roadmaps and Approaches
WORC Community • NAM Evidence Hub
Explore NAM Standardisation & Global Roadmaps
Switch between the living PubMed standardisation literature table and the global NAM policy & adoption roadmap comparison.
WORC Community • Living PubMed literature table
NAM Standardisation approaches
Highlighted Papers and articles: 1 January 2023 to present.
Papers shown:
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Highlighted NAM Standardisation Papers
25 highlighted papers • scroll to explore • 5 shown at a time on desktop
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Paper / DOI / PubMed / Journal | Authors | Institution(s) / Company | NAM / Model | Standardisation / Quality Significance |
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Highlighted Roadmaps for Non-Animal Methods & NAM Adoption
| Policy / Feature | Replacing Animals in Science Strategy | EU Roadmap | FDA NAM Regulatory Transition | Human-Based Research Funding | CEPA NAM Strategy | 3Rs + NRP 79 | PMDA NAMs Initiative | RENAMA + CONCEA |
|---|---|---|---|---|---|---|---|---|
| Key initiative | Replacing Animals in Science Strategy | Roadmap towards phasing out animal testing for chemical safety assessments | FDA Modernization Act 3.0 / wider FDA NAM transition | NIH initiative to prioritise human-based research technologies | Strategy to replace, reduce or refine vertebrate animal testing under CEPA | Swiss 3Rs policy + National Research Programme 79 | PMDA New Approach Methodologies Initiative / Working Group | RENAMA + CONCEA alternative-method framework |
| Current period | 2025 onward | 2026 onward | 2025–26 onward | 2025 onward | 2025 onward | 2022–27 | 2025–26 onward | Active / expanding in 2026 |
| Type | National government strategy | EU-wide regulatory roadmap | Legislation / regulatory reform | Federal research-funding policy | Statutory strategy | Legislation + national research programme | Medicines-regulator programme | Regulatory framework + national NAM network |
| Main organisation | UK Government / MHRA | European Commission / EU agencies | FDA / HHS | NIH | Health Canada / Environment and Climate Change Canada | Swiss federal authorities / research system | PMDA | ANVISA / CONCEA / RENAMA |
| Main objective | Accelerate replacement of animal methods through development, validation, qualification and regulatory uptake of alternatives. | Transition chemical safety assessment towards non-animal approaches. | Implement modern nonclinical approaches within FDA-regulated drug development. | Prioritise human-based research technologies and reduce reliance on animal models in NIH-funded research. | Replace, reduce and refine vertebrate animal testing and incorporate NAMs into risk assessment. | Advance the 3Rs and increase development and use of alternatives to animal experiments. | Improve prediction of human safety, efficacy and pharmacokinetics using NAMs. | Develop, recognise, validate and implement alternative methods and NAMs. |
| Regulatory adoption | Central | Central | Central | NIH is primarily a research funder rather than medicines regulator | Central to risk assessment | Alternatives embedded within 3Rs framework | Central emerging objective | Alternative methods recognised in regulation |
| Funding NAM development | ✓ Yes | ✓ Yes | Not FDA's primary role | Central NIH role | ✓ Yes | ✓ National research funding | Research collaboration and programme support | ✓ Yes |
| Animal replacement / reduction objective | Explicit replacement ambition | Long-term phase-out objective for animal testing in chemical safety assessment | Reduce reliance and enable scientifically appropriate non-animal alternatives | Reduce reliance on animal models while expanding human-based research | Replace, reduce and refine | Replacement embedded in the national 3Rs framework | Reduce reliance on animal models while improving human prediction | Replace, reduce and refine |
| Standardisation / harmonisation | Qualification, robustness, reproducibility and validation | Strong emphasis on regulatory harmonisation and common assessment frameworks | Regulatory implementation and qualification | Reproducibility, standardisation and broad usability of human-based technologies | Standardisation and incorporation into risk assessment | 3Rs implementation and alternative-method development | International collaboration including global standards and regulatory convergence | Validation and formal recognition of alternative methods |
| Best shorthand | Validation → Adoption | System Transition | Regulatory Implementation | Fund Human-Based Science | NAM Integration | 3Rs + Alternatives | Human-Predictive Development | Build NAM Capacity |