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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publicMHRA · United Kingdom · Updated Jun 29, 2026

MHRA: Updated information on the MHRA's service providing scientific and regulatory guidance to developers of innovative medical products

Monitoring

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guidance

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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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