By Hannah Kerfoot 

 

What is IRIS? 

Like its Ancient Greek mythologic namesake, Iris the messenger of the Gods, the IRIS platform has been developed by the European Medicines Agency (EMA) to ensure open communication during submissions by Market Authorisation Holders (MAHs).  

When will it start to come into effect?  

It was first launched in 2018 for Orphan designation procedures and now the system is gradually being rolled out to cover other regulatory areas in different ways. Since 2020, it has served as a platform for MAHs to request scientific advice from the EMA during submissions.  

The most recent updates to its use involve the change to post-authorisation procedures. From January 2025, any post-authorisation procedures which have been submitted to the EMA on or after the 20th of December 2024 will be managed in IRIS. Additionally, periodic safety update reports (PSURs) will transition to IRIS from the 6th of February 2025 onwards.  

What do MAHs need to do during this transition? 

Hopefully, MAHs should have already requested to register in the EMA IAM (Identity and Access Management 2) by October 2024, and if so, now they will be transitioning their post-authorisation communication to IRIS. Additionally, advice has been to ensure that everyone who needs access to the IRIS system is registered, to ensure that all communications from the EMA on the IRIS platform are answered in a timely manner.  

Why have the EMA chosen to do this?   

There are multiple reasons why the EMA have decided to switch to this system. One is to potentially streamline the EMA’s processes and reduce time needed for applicants to prepare and submit applications. It also means there will be better data quality, since the IRIS platform allows data to be integrated with other EMA systems. Also, users can check the status of their applications and are notified if there are changes, thus communication with the EMA could be much faster than the old system. Direct and quick communications will allow MAHs to gather and submit any data the EMA needs to evaluate their products faster.  

With regards to patients, the move to the IRIS system could help with improving patient-centricity (a big theme in the pharmaceutical industry in recent years), especially from a perspective of improving the speed of submissions. Not only that, but any safety signals or concerns spotted by the EMA or client will be addressed or checked faster, through the IRIS platform. Additionally, if communications are through the IRIS platform, there is a guarantee that these communications are clearly recorded, which means that the system will be more transparent, another plus for patients. 

What support can MAHs get from the EMA? 

Learning a new system and way of working could be challenging for companies who are familiar the previous communications system. However, the EMA have provided multiple resources to support MAHs who are trying to adapt to IRIS.  

The EMA have provided forums, guidance, and instructions. Additionally, there are multiple YouTube videos available for different scenarios, including how to register for access, how to submit initial and follow-up scientific advice applications, and EMA IRIS Inspections Industry training.  

Please follow this link to visit our main website and find out more about Pharmora!