New Approach Methodologies (NAMs) have the potential to transform global drug development in the next few years. Global governments and regulators have recently put intense focus on integrating NAMs data to replace animal methods in drug development. This focus appears to have intensified in 2025 with different regulators in multiple regions seeking to use NAMs to replace animals. NAMs companies and drug developers have a unique opportunity to benefit from this change.
However, with such broad attention on NAMs, it is no surprise that differing governments have different understanding, definitions, and approaches to them. NAMs have always been plagued by unclear definitions. But with the pivot to NAMs now having direct, practical impacts, it is critical for NAMs developers, users, and even regulators to understand how these different definitions might affect NAMs approval and adoption.
A key case of this gap is the definitions of “Validation” and “Qualification”. These two terms are likely the most critical to NAMs adoption and are widely discussed. However, these two terms can vary so significantly between regulators, as to nearly invert their relationship. One of the oldest NAMs-focused organizations is the US ICCVAM. Their 2024 report on “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies” provides a comprehensive list of definitions, including those two critical titular terms. The UK’s widely reported 2025 “Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods” (which establishes UKCVAM) also provides definitions of those two terms. Table 1, below, provides the definitions directly from the two publications.
| US ICCVAM Report on NAMs | UK Replacing Animals Strategy | |
| “Qualification” Definition | A conclusion that the results of an assessment using a validated model or assay can be relied upon to have a specific interpretation and application in product development and regulatory decision-making. (p 48) | A process by which a non-animal method is demonstrated to be fit-for-purpose; and have sufficient reliability and rigor in a specific context of use to give confidence that decisions made based on data generated in these methods are robust. Qualification may also set expected criteria to be used in the subsequent validation. (p 53) |
| “Validation” Definition | The process by which the accuracy, reliability, and relevance of a procedure are established for a specific purpose. Validation for one specific purpose does not imply validation for other specific purposes. Further qualification may be needed for a particular context of use. (p 50) | A process by which a non-animal method is demonstrated to consistently produce reliable results meeting pre-determined quality standards and acceptance criteria in a specific context of use. Validation of a test method is required for data generated in them to be accepted for regulatory decision making. (p 54) |
The takeaway: The US considers qualification a mechanism for regulatory decision-making which follows validation; the UK considers validation a mechanism for regulatory decision-making which follows qualification.
These differences DO NOT implicitly suggest error or misalignment between the two groups. ICCVAM’s qualification definition is in line with FDA practices, as described with their well-established Drug Development Tool Qualification Program. Meanwhile, the UK’s definitions are closer to more traditional concepts of design or process qualification and validation. Both definitions are valid, well-investigated, and satisfy requirements within their own jurisdictions.
Regardless, it is of critical importance for all stakeholders to be aware of these differences:
- NAMs Developers – Be conscious that these have different meanings for different agencies. Informing the UK your system has received US “Qualification” may not be interpreted as you anticipate.
- Drug Developers – When submitting NAMs data in preclinical contexts, ensure the phrasing and impacts are well described if submitting data to different agencies.
- Regulators – Understand that NAMs data described at one standard may not meet the same requirements in your jurisdiction. For example, UK NAMs data may be submitted to FDA with a “Qualification” designation. This may not rise to the same standard expected by your agency.
As focus on NAMs accelerates, understanding and navigating these differences will be key.
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