Insight Blog
Navigating New Approach Methodologies (NAMs): a practical guide for developers
Download the full White Paper here
For many years, animal studies have been a standard part of bringing new medicines to market. That is starting to shift, and not just in principle. Regulators around the world are building frameworks for what is known as New Approach Methodologies, or NAMs: non-animal methods that generate or integrate human-relevant data to support the assessment of new treatments.
This concept is now being brought into regulatory practice. In the US, legislative and the FDA's roadmap support for the reduced use of animal testing; in the UK, the government has committed to accelerating the uptake of non-animal methods; and in the EU, the European Commission is preparing a roadmap towards the phased reduction and replacement of animal testing. Regulators across the world are beginning to engage with NAMs through formal regulatory pathways and international collaboration.
For drug developers, this creates both opportunity and complexity. The direction may be clear, but the details, including which methods regulators will accept, in what contexts, and how to position them in a regulatory submission, are still evolving. Each agency has its own mechanisms, timelines and expectations, and effective implementation requires understanding the regulatory landscape around it.
This is the focus of this White Paper. Drawing on published guidance, regulatory frameworks and real-world examples, our regulatory expert maps out how the MHRA, EMA and FDA are approaching NAM adoption, where expectations are most advanced, where gaps remain, and what developers should be doing now to prepare.
The white paper covers:
- What regulators actually mean by NAMs, and the range of methods that fall under the term;
- How major agencies are supporting adoption, from legislation and guidance to scientific advice procedures;
- How NAMs evidence is evaluated, including the four principles that shape regulatory assessment;
- Where limitations remain and what that means in practice;
- What developers should do next: practical steps for integrating NAMs into development programmes
Whether you're already exploring New Approach Methodologies or just starting to consider them, this White Paper serves as a practical guide to a fast-evolving regulatory landscape.