Regulatory intelligence &amp; pharmacovigilance updates, mapped to your role.

Local Affiliate ComplianceInspection ReadinessLocal Safety Officer

Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; confirm local obligations and document follow-up actions.

SOP Impact5 SOPs

Relevant for: Local Safety Officer, Signal Management Lead, PV Quality Lead

verifiedRegulatory action: Country Guides

publicFda · Updated May 22, 2026

FDA MDR hub highlights VMSR guidance and quarterly malfunction reporting

Local Affiliate ComplianceICSR SubmissionLocal Safety Officer

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

SOP Impact4 SOPs

Relevant for: Local Safety Officer, Regulatory Intelligence Lead, PV Operations Lead

verifiedRegulatory action: Devices

publicEma · Updated May 22, 2026

MHRA reiterates GxP data integrity spans GVP as Annex 11 evolves

Local Affiliate ComplianceVendor OversightQPPV

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

SOP Impact7 SOPs

Relevant for: QPPV, Local Safety Officer, Signal Management Lead

verifiedRegulatory action: AI/GxP

publicMhra · Updated Jun 10, 2025

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Signal ValidationRisk ManagementLocal Safety Officer

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

SOP Impact9 SOPs

Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Country Guides

publicHealth Canada · Updated May 22, 2026

Health Canada reposts device recall forms and updates GVP GUI-0102

Local Affiliate ComplianceDevice VigilanceLocal Safety Officer

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

SOP Impact4 SOPs

Relevant for: Local Safety Officer, Regulatory Intelligence Lead, Medical Device Vigilance Lead

verifiedRegulatory action: Regulators

publicUpdated May 21, 2026

InSphero acquires PhenoVista, expanding 3D assay and imaging services

Risk ManagementVendor OversightQPPV

This update requires triage for Risk Management, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

SOP Impact4 SOPs

Relevant for: QPPV, Signal Management Lead, Labeling Lead

verifiedRegulatory action: Company Watch

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Signal ManagementLabelingRegulatory Intelligence Lead

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

SOP Impact2 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead

verifiedRegulatory action: Regulators

publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Country ComplianceRegulatory Intelligence Lead

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead

verifiedRegulatory action: Regulators