Posted Fri, 03 Jan 2025 11:09:37 GMT by Jorg Schneidereit Mr
The new EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance (dated 13 December 2024) still provides for follow-up scientific advice (e.g. in response to Q26: "In some cases, e.g. as a result of scientific developments, an alternative approach to that advised may be preferred. In this case it is recommended to Applicants to request a follow-up to the initial scientific advice or protocol assistance given"), but the option to submit a follow-up scientific advice is no longer available in the IRIS portal, only initial advice.
This deprives the applicant of the opportunity to identify their submission in IRIS as a follow-up advice and to link their submission to previous advice. This can only be done via the briefing book. 
How do I submit follow-up scientific advice using the current IRIS interface?
Posted Mon, 06 Jan 2025 17:22:49 GMT by Tarita Toufexi Ms
We are currently operating under the new fee regulation (Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency), which came into force on January 1st 2025.

The new fee regulation has introduced changes to Scientific Advice/Protocol Assistance.

Notably, the structure of scientific advice types and associated fees has been simplified. Consequently, distinctions between initial and follow-up requests have been removed, and follow-ups are no longer available as process types in the IRIS system.

However EMA staff are still able to follow the lifecycle of a specific product and previous advices via the RPI that is the link between all pre-authorisation procedures.

You must be signed in to post in this forum.