PV Bulletin

Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing

The European Medicines Agency (EMA) now supports the regulatory acceptance of innovative testing methods known as New Approach Methodologies (NAMs) in the EU.

Primary source: Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline

PV Impact Brief

Urgency: HighConfidence: high

What changed

The guidelines now specify the process for the regulatory acceptance of NAMs, detailing how developers can engage with EMA's Innovation Task Force and submit data for evaluation.

Why it matters

This shift towards NAMs is significant as it can lead to reduced reliance on animal testing, promoting more ethical practices in medicine development and aligning with the principles of the '3Rs'.

Action needed

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 1, 2026

Full briefing

Practical implication

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

The EMA has introduced guidelines promoting the regulatory acceptance of new approach methodologies (NAMs) that aim to replace, reduce, and refine traditional animal testing. This initiative encourages developers to interact with EMA through informal discussions about their NAMs and aids in assessing their readiness for regulatory decision-making.

What changed: The guidelines now specify the process for the regulatory acceptance of NAMs, detailing how developers can engage with EMA's Innovation Task Force and submit data for evaluation.

Why it matters: This shift towards NAMs is significant as it can lead to reduced reliance on animal testing, promoting more ethical practices in medicine development and aligning with the principles of the '3Rs'.

Practical implication: Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

View original source

  • Source: EMA - What's new
  • Published at source: 2026-09-01T11:48:00.000Z
  • Discovered by monitor: 2026-09-01T21:48:03.578Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Guidance#Source-ingestion#Regulator-monitor#European Union#Ema.europa.eu

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