policy-change

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

SOP Impact2 SOPs

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

verifiedRegulatory action: Notice

publicTherapeutic Goods Administration (TGA) · Australia · Updated Jun 5, 2026

TGA Consultation on Radiopharmaceutical Regulation in Australia

Country ComplianceRegulatory Intelligence Lead

Review the consultation document and consider submitting feedback by 2026-07-31. Monitor for final regulatory changes affecting radiopharmaceutical safety monitoring and compliance.

SOP Impact1 SOPs

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Consultation

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

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

LabelingRegulatory Intelligence Lead

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

SOP Impact1 SOPs

Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV

verifiedRegulatory action: Checklist

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

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

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

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

SOP Impact2 SOPs

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

verifiedRegulatory action: SOP