Signal Management

MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

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.

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

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

Tga update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

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

This update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

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