RE: RE: 66 Days!31 May 2024 16:26
Understood Older, to me it would be about minimising risk of delay to the process or worse.
Its just like a developer would never submit a planning application without a pre-application meeting to understand initial thoughts and how receptive those who make the decisions are to the proposals.
Also from the EMA website.
"EMA strongly encourages sponsors to request a pre-submission meeting with the Agency prior to filing an application. Pre-submission meetings usually take place via teleconference, unless the sponsor has a strong preference to come to EMA in person.
If a sponsor feels they could benefit from a preliminary discussion before the submission of an orphan drug application, they can request a pre-submission meeting/teleconference at least two months prior to their planned submission date via the IRIS portal. This should allow enough time for the organisation and any amendment of the application as recommended by EMA.
Sponsors should create an initial draft application for orphan designation before creating the application for the pre-submission discussion. These are two separate submissions to be made in the IRIS system. The draft submission for orphan designation should be populated with the relevant data and documents, but not submitted, at least one week before the pre-submission meeting date.
Pre-submission meetings are useful since the evaluation process has a fixed duration of 90 days and cannot be lengthened to accommodate for the lack of data or other omissions in the application. Experience has shown that they have a positive impact on the success rate of the applications."