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:
• human medicines:
o Initial and Follow-up Scientific Advice;
o Initial and Follow-up Protocol Assistance;
o Initial and Follow-up Qualification Procedure;
• veterinary medicines:
o Initial and Follow-up Scientific Advice.
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.
Registration steps
Users should complete the registration steps below before using the IRIS platform. The Quick interactive guide to IRIS registration process provides a summary to ensure that:
• you have an active EMA account;
• your organisation is registered in EMA’s Organisation Management Service (OMS). It can take from five to ten working days to update or register a new organisation;
• you have the appropriate user access role and affiliation to an organisation. IRIS user roles are requested in the EMA Account Management portal.
To submit your scientific advice application via IRIS you will also need to ensure that:
• you have a valid EMA customer account number, which is a unique reference number for financial matters required to submit scientific advice applications;
• you have a valid Research Product Identifier (RPI) that EMA uses to track medicines through pre-authorisation procedures. Requests for new RPIs, including requests for transfers of RPIs, are submitted via IRIS. If a request for an RPI also requires registration of an active substance in EMA’s public list of substances, this may take up to five working days.
EMA’s revised IRIS guide to registration explains the registration steps in more detail.
Virtual training sessions
EMA is also offering virtual training sessions on using IRIS for scientific advice procedures, in advance of 19 October.
• Online training: How to submit Initial and Follow-up Scientific Advice applications (human) using IRIS (13/10/2020)
• Online training: How to submit Initial and Follow-up Scientific Advice applications (veterinary) using IRIS (14/10/2020)
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.
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