As evidenced by the FDAs impending mandate that drug and life science companies switch from paper to eCTD format, the Agency is serious about transitioning to electronic submissions.
The FDA is on the verge of instituting a change that will fully automate the process for those in the industry already submitting in eCTD. This is all part of the refinement underway to prepare for the overwhelming amount of electronic submissions expected as the mandate takes effect.
With the human element gone from the process, there is no flexibility, no margin for error.
The Agency recently updated to eCTD Validation Criteria Version 2.2, giving them the capability to accept or reject a submission on technical merit without the possibility of human intervention.
Currently, a submission is loaded onto the Agency server and run through validation software. Error reports are then generated, and subsequently reviewed for legitimacy by a member of the FDA team.
Once the fully-automated system is implemented, detection of a high-level error could meet the system’s threshold, and trigger technical rejection. A high-level error might simply be a case of misinterpreting FDA guidance, or using a publishing tool not updated with the latest validation criteria.
All indications point to the FDA announcing the fully automated system shortly, as they’ve given the industry sufficient lead time to prepare. To guard against technical rejection, it is essential that all eCTD submissions contain as few errors as possible – and are reviewed from the same vantage point as the FDA.