Tag archive

Regulatory Intelligence

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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publicSwissmedic · Switzerland · Updated Jun 15, 2026

SEND Format Requirement for New Authorisation Applications in Switzerland

Urgency: High

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Notice

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