Draft eCTD Validation Specification Includes 50 New Errors

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The FDA has published a draft of updated eCTD validation criteria which will become final once the FDA implements a new version of GlobalSubmit VALIDATE. The new specification includes over 50 new errors which were not previously checked. Several of these errors will receive a technical rejection.

To understand the need to reject submissions, one has to understand the scale of the problem that poor submissions impose. As eCTD submissions have become the norm for transferring regulatory information to the FDA, the number of eCTD submissions has steadily increased. In December 2010, over 7,000 submissions were received by the FDA from the electronic gateway. To put that in perspective, that is a new submission every 75 seconds of every workday. With these quantities, it is no longer possible for a human to process these submissions as they arrive. Instead, more and more of submission processing is automated. When this goes smoothly, the submission is available for review within 10 minutes of being received, and the first human to see the submission is the reviewer. 

To ensure smooth processing, high errors are automatically rejected, and submissions that contain only medium and/or low errors are further examined to determine whether to accept or reject the submission. During Jared Lantzy’s presentation at the DIA EDM show last week, he pled with the audience to pay attention to the medium and low errors as they can lead to a rejection. While a specific date has not been set to check the new errors, these changes are imminent and cannot be ignored.


Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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