A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.
Submissions metrics for the US FDA’s new Module 1 shared with industry at the DIA RSIDM 2016 Forum paint a picture of modest activity for the enhanced specification. As of February 1, 2016, 117 companies submitted a total of 1,639 sequences of varying application and submission types.
The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten Agency rules. Bear in mind that subtle differences exist among vendors who have implemented eCTD systems. You need to ensure that your chosen vendor has experience migrating submissions, not only from your existing system, but from all systems that generated eCTD that you now have to manage.
The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.
The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.