New online platform for scientific advice
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Human
Veterinary
Corporate
Scientific advice
From 19 October 2020, developers of human or veterinary medicines should use EMA’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice.
At any stage of a medicine's development, the developer can ask for guidance and direction from EMA, known as scientific advice, on the best methods and study designs to generate robust data on how well a medicine works and how safe it is.
The procedures concerned are:
The IRIS platform will provide a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning each scientific advice procedure.
Medicine developers wishing to apply for scientific advice must first be registered to use IRIS. Guidance is available on how to register for and use IRIS for scientific advice and other regulatory procedures.
Users should complete the registration steps below before using the IRIS platform. The Quick interactive guide to IRIS registration process a summary to ensure that:
To submit your scientific advice application via IRIS you will also need to ensure that:
EMA’s revised IRIS guide to registration and RPIs explains the registration steps in more detail.
EMA is also offering virtual training sessions on using IRIS for scientific advice procedures, in advance of 19 October.
EMA will publish updated procedural guidance on requesting scientific advice using IRIS when the new process goes live on 19 October. Until 19 October, EMA’s current procedural guidance applies.
The IRIS platform was first launched in 2018 for orphan designation procedures. EMA is gradually rolling it out to cover other regulatory and scientific business areas.
IRIS helps to streamline EMA processes and reduces the overall time needed for applicants to prepare and submit applications for scientific procedures. It also ensures better data quality through integration with other EMA systems. Users will be able to check the status of their applications across multiple devices and will receive automatic updates when their status changes.