The eCTD Summit: Coming Soon: New eCTD Validation Criteria for the FDA

The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.

When is the FDA going to move to the new validation criteria?

The FDA has mentioned various estimated dates and the draft version does mention that the deployment is scheduled for June 2011; however, the new criteria have yet to be formally implemented. The last I’ve heard is that the new criteria is currently under test. The FDA is evaluating the changes, and will be moving to the new version sometime in the next few months. Currently they are still validating with the previous criteria, and using the GlobalSubmit VALIDATE version 4 to do so.

So what are some of the major changes to the criteria?

First off, there has been a lot of work done on cleaning up existing errors. Within the draft guidance, fourteen errors have been removed from the list. This was to clean up redundant checks, a change in the criteria, or the error can no longer be triggered based on the validation tools behavior.

For more information click here: The eCTD Summit: Coming Soon: New eCTD Validation Criteria for the FDA