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Found 2 result(s) for "Signal Management".

Showing 1-2 of 2 published article match(es)

publicMhra · United Kingdom · Updated May 23, 2026

MHRA clarifies PSUR submission routes for Category 1 vs Category 2

1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer

SOP Impact8 SOPs

ConfidenceHigh

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

verifiedRegulatory action: Country Guides

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publicMhra · Updated Jun 10, 2025

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Urgency: High

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

Signal ValidationRisk ManagementLocal Safety Officer

SOP Impact9 SOPs

ConfidenceMedium

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

verifiedRegulatory action: Country Guides

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