Helping Researchers and Developers Gain Regulatory Approval for New Approach Methodologies.
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Timeline overview
See here an overview of the different steps necessary for validation and approval, and the associated agencies for each step.
1. Research & Development
About preparation, documentation and more
See OverviewUniversities
Research & Tech offices
Datasteward
Knowledge Institutes
RIVM, WFSR, TNO, et cetera
2. Standardization
About standardization in the development, implementation, and validation of NAMs.
About Standardization3. Validation
What data should you have to make validation of your NAM go quicker?
See OverviewAgencies for Safety Assessment of Pharmaceutical Products
EURL ECVAMEMA-SAWPAgencies for Safety Assessment of Chemical Substances
EURL ECVAMPAREREEU-NETVAL (WFSR, TNO, Triskelion,Charles River)ESACOECD
4. Acceptance
Last step after the validation study and peer-review is regulatory acceptance.
About AcceptanceAgencies for Safety Assessment of Pharmaceutical Products
EMA-CHMPICH AssemblyAgencies for Safety Assessment of Chemical Substances
OECD-WNTECHASCCSESACEFSAThis overview has been adapted from the RIVM “Landscape New Approach Methodologies (NAMs) safety assessment chemical substances” and the RIVM 'Landscape New Approach Methodologies (NAMs) safety assessment pharmaceutical products'.
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The NAM Navigator was commissioned by TPI under the direction of the More Knowledge with Fewer Animals program of ZonMw.
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