MAHs and sponsors must now use the updated IRIS portal for safety reporting and signal management, effective June 15, 2026.
Compliance with the latest digital submission standards is essential for regulatory submissions in the EU, impacting pharmacovigilance-related processes.
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.
Regulatory Intelligence Lead
Review before 2026-06-15.
Updated instructions for platform navigation, user registration, and data management for regulatory procedures. It reflects the latest system features for the 2026 rollout of IRIS services.
MAHs and sponsors are required to use the updated IRIS portal for safety reporting and signal management. This update ensures compliance with the latest digital submission standards for EU pharmacovigilance.
User roles must be managed to ensure appropriate submission access and compliance.
Separate user access roles are required for Parallel Distribution submissions.
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.
The EMA updated the IRIS guide, requiring Marketing Authorization Holders (MAHs) and sponsors to utilize the updated IRIS portal for safety reporting and signal management. This update, effective from June 15, 2026, aligns with the latest digital submission standards in EU pharmacovigilance.
What changed: MAHs and sponsors must now use the updated IRIS portal for safety reporting and signal management, effective June 15, 2026.
Why it matters: Compliance with the latest digital submission standards is essential for regulatory submissions in the EU, impacting pharmacovigilance-related processes.
Practical implication: 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.
Published from the Firecrawl policy change extraction pipeline.
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