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Ema.europa.eu

publicEuropean Medicines Agency · European Union · Updated Sep 1, 2026

Voluntary Data Submission Pilot to Advance Innovative Alternatives to Animal Testing

Monitoring

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

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicEuropean Medicines Agency (EMA) · European Union · Updated Aug 26, 2026

Monthly Reporting of Medicines Under Evaluation by EMA

Monitoring

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward

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