New Approach Methodologies NAMs

Regulators worldwide are actively developing pathways to accelerate the use of NAMs.

Recent initiatives from the FDA, EMA, and MHRA demonstrate growing support for scientifically validated, human-relevant, and fit-for-purpose approaches with well-defined contexts of use in drug development.

Medicines & Healthcare products Regulatory Agency - March 2026

"MHRA Approach to Medicines Using Non-Animal Methods"

The UK's MHRA has established a framework for early engagement around medicines developed using non-animal approaches. The initiative provides developers with opportunities to discuss NAM-generated evidence before formal regulatory submission.

Food and Drug Administration (FDA) - March 2026

"General Considerations for the Use of New Approach Methodologies in Drug Development"

The FDA released draft guidance outlining how NAMs can be incorporated into drug development programs. The guidance emphasizes fit-for-purpose validation, context of use, and the generation of reliable evidence to support regulatory decision-making.

European Medicines Agency (EMA) - December 2025

"Reframing the voluntary data submission to foster regulatory acceptance of NAMs"

The European Medicines Agency continues to expand initiatives encouraging developers to submit NAM-generated evidence. These efforts aim to build regulatory experience with emerging technologies while accelerating their integration into drug development workflows.