Tag archive

revised

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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publicCanada's Drug Agency (CDA-AMC) · Canada · Updated Jun 5, 2026

CDA-AMC Post-Market Drug Evaluation (PMDE) Program Procedural Update

Monitoring

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: SOP

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