PV Bulletin

Voluntary Data Submission Pilot to Advance Innovative Alternatives to Animal Testing

The European Medicines Agency (EMA) has launched a voluntary data submission pilot for developers to present New Approach Methodologies (NAMs) data.

Primary source: View

PV Impact Brief

MonitoringConfidence: high

What changed

A voluntary data submission pilot has been initiated, enabling stakeholders to submit NAMs data for consideration independent of existing regulatory procedures.

Why it matters

This initiative promotes the use of innovative testing methodologies, potentially leading to reduced reliance on animal testing and more efficient regulatory decision-making.

Action needed

Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Country Compliance
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

Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.

The EMA's new pilot allows stakeholders to submit NAM data for tailored feedback, aiming to facilitate innovative alternatives to traditional animal testing.

What changed: A voluntary data submission pilot has been initiated, enabling stakeholders to submit NAMs data for consideration independent of existing regulatory procedures.

Why it matters: This initiative promotes the use of innovative testing methodologies, potentially leading to reduced reliance on animal testing and more efficient regulatory decision-making.

Practical implication: Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.

View original source

  • Source: EMA - What's new
  • Published at source: 2026-09-01T13:48:00.000Z
  • Discovered by monitor: 2026-09-02T21:45:26.922Z

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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