EMA IRIS System Updates: New Account Requirements for PSUR Submissions Starting September 2025

Key Takeaways

• Starting September 1, 2025, Marketing Authorisation Holders must have IRIS-affiliated primary contacts for PSUR submissions
• Initial Marketing Authorisation Applications (iMAAs) delayed from 2025 to Q1 2026
• Changes affect all pharmaceutical companies submitting regulatory documents through EMA’s IRIS system

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The European Medicines Agency (EMA) has announced significant updates to its Integrated Regulatory Information System (IRIS) that will impact pharmaceutical companies’ regulatory submission processes starting September 2025.

New PSUR Submission Requirements

Effective September 1, 2025, Marketing Authorisation Holders (MAHs) will face stricter account verification requirements for Periodic Safety Update Report (PSUR) submissions. The EMA will no longer accept PSUR submissions where the primary contact listed on the submission form lacks an IRIS account properly affiliated with the product’s MAH.

This change represents a significant shift in the EMA’s approach to regulatory oversight, emphasizing enhanced accountability and traceability in pharmaceutical safety reporting. PSURs are critical documents that provide ongoing safety assessments of marketed medicines, making proper contact verification essential for regulatory compliance.

iMAA Timeline Extended

In a separate development, the IRIS team has updated its roadmap for initial Marketing Authorisation Applications (iMAAs), pushing the anticipated go-live date from late 2025 to Q1 2026. This delay affects companies preparing new drug applications through the centralized European authorization procedure.

The postponement suggests the EMA is taking a cautious approach to system implementation, likely ensuring robust testing and stakeholder readiness before launching the new iMAA functionality.

Industry Impact

These changes require immediate attention from pharmaceutical companies operating in the European market. Organizations must audit their IRIS account structures and ensure proper affiliations between personnel and marketing authorizations well before the September deadline.

The updates reflect the EMA’s ongoing digital transformation efforts, aimed at streamlining regulatory processes while maintaining rigorous oversight standards. Companies should begin preparing now to avoid potential submission delays or rejections due to non-compliance with the new requirements.

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Frequently Asked Questions

What happens if my company’s PSUR primary contact doesn’t have an affiliated IRIS account after September 1, 2025?

The EMA will not accept your PSUR submission, potentially leading to regulatory non-compliance and requiring resubmission with a properly affiliated contact.

When will the new iMAA system be available for initial marketing authorization applications?

The EMA has delayed the iMAA go-live from 2025 to Q1 2026, though no specific date within that quarter has been announced.

How can pharmaceutical companies prepare for these IRIS system changes?

Companies should audit their current IRIS accounts, ensure proper MAH affiliations for all primary contacts, and establish backup qualified personnel before the September 2025 deadline.