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policy-change

publicEuropean Medicines Agency · European Union · Updated Jun 5, 2026

EMA: Updated Day 215 PI Annex Submission Checklist for Post-Opinion Linguistic Review

Update internal labeling workflows to align with the revised checklist; ensure submission documents meet updated formatting requirements for linguistic review.

LabelingRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV

verifiedRegulatory action: Checklist

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publicEuropean Medicines Agency · European Union · Updated Jun 24, 2026

ICH E22 Guideline on Patient Preference Studies Comments Overview

Monitoring

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.

LabelingSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Signal Management Lead, Labeling Lead

verifiedRegulatory action: Consultation

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