The European Medicines Agency (EMA) is set to enhance the management of post-authorisation procedures by transitioning to its new Information System (IRIS). This shift aims to streamline processes for Centrally Authorised Products (CAPs) and associated non-CAPs, ensuring more efficient handling of submissions from December 20, 2024.
Key Procedures Moving to IRIS
Starting January 8, 2025, the EMA will officially host a questions and answers clinic to guide stakeholders through the transition to IRIS. The transition encompasses a range of procedures, including Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies, and Referrals. These changes will affect submissions submitted via the existing systems like Gateway and the PSUR repository.
Initial Transition Phases
The first phase of the IRIS transition began on January 23, 2024, focusing on onboarding variations, Article 61.3 notifications, and marketing authorisation transfer procedures for a select group of human and veterinary CAPs with low regulatory complexity. Periodic Safety Update Reports will follow, with their transition scheduled to start on February 6, 2025, in alignment with the PSUR procedural timetable.
– Enhanced efficiency expected in post-authorisation processes
– Increased transparency and data management through IRIS
– Potential for reduced processing times for submissions
– Improved stakeholder support with dedicated Q&A sessions
– Gradual implementation ensures minimal disruption to current workflows
The seamless integration of IRIS is poised to revolutionize how post-authorisation procedures are managed within the EMA framework. By centralizing and updating submission systems, the EMA aims to provide a more robust and user-friendly platform for industry stakeholders.
Adopting IRIS will not only streamline regulatory processes but also enhance the overall quality and safety monitoring of medicinal products across the European Union. The dedicated support through clinics and detailed transition timelines underscores EMA’s commitment to a smooth and effective implementation.
EMA’s proactive approach in transitioning to IRIS demonstrates a significant step towards modernizing regulatory processes. Stakeholders are encouraged to participate in the upcoming Q&A clinic to gain comprehensive insights and ensure a successful adaptation to the new system. This move promises to bring substantial benefits in terms of efficiency, transparency, and regulatory compliance, ultimately supporting public health objectives across Europe.

This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.