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revised

publicEuropean Medicines Agency · European Union · Updated Jun 15, 2026

IRIS Guide for Applicants - Updated Submission Requirements

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.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: Procedural Guidance

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publicEuropean Medicines Agency · European Union · Updated Jun 15, 2026

IRIS guide to registration and RPIs

Urgency: High

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

Country ComplianceSignal ManagementRegulatory Intelligence Lead

SOP Impact2 SOPs

ConfidenceHigh

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

verifiedRegulatory action: Procedural 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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