eCTD Validation Criteria v2.2 FAQs

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GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria.

The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager, Strategic Regulatory Innovation, Novo Nordisk Inc., GlobalSubmit’s CTO Jason Rock discussed the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

Q: FDA forms have PDF security. Is this a problem in validation, and if so, how should it be dealt with?

A: Any file in the forms sections will not be validated again PDF checks; for example, PDF security. Forms have special validation; for example, ensuring that the application number is correct.

 Q: Some ICH regions have provided free validation tools as a collaborative effort between agency and vendor. Does FDA/GlobalSubmit have any plans to provide a free validation tool to industry?

A: Currently neither GlobalSubmit nor the FDA has plans to provide free validation tools to the industry.

 Q: When will the new FDA Validation criteria version 2.0 be implemented at the agency? The FDA website says November 2011. Is this still the time frame?

A: No, the tentative date is February 2012.

Q: How do we get a list of validation errors from the FDA from each of our submissions?

A: You should request the validation errors from your Project Manager.

Q: We have numerous CBER multi-BLAs (both with multiple products in a single application number), and numerous applications where we submit a single submission impacting all the applications.  Can you provide more details on the multi-product aspects of CBER product submissions?  Is it for multiple products in one application, or submissions across multiple applications?

A: Trans BLAs, a CBER program, can target multiple products. CDER does not have such a program. The FDA has provided a draft specification that will allow CDER and CBER to accept one submission to multiple applications.

Q: If during the lifecycle we accumulate errors, is there any “baseline” submission possible?

A: Unfortunately, no. eCTD does not have any mechanism to fix mistakes in attributes or clean up misplaced documents.

Q: For the validation criteria “STF doc-content title and leaf title must match”, what elements is this criterion looking for? Is it looking for the Name of the Study Report folder to match the value of the Full Report Title, instead of the Report Number?

A: This error looks for the Leaf’s Title and the Study Tagging File Title. These two titles must be the same.

Q: Is there any real benefit to the sponsor in using fillable forms and is there a timeline for fillable forms to be mandated by the FDA?

A: The benefit to the sponsor is that the submission will be routed to the reviewer quicker.

Q: We’ve never had any issues to date re: our forms.

A: The FDA has not been systematically rejected submission based on the application form. The FDA have announced that rejections can be expected based on the form not being fillable when the implement the new validation criteria.

Q:  About the fillable forms, if the chemical name is truncated in the form, does that affect the review process? Should we send a scanned copy with the full name?

A:  This does not have an effect on the review process.

Q:  Have complete response letters been issued for electronic submission errors, or just based on submission content?

A:  Complete response should be for scientific reasons. If there are technical issues in your submission, finding content might be difficult. This can lead to a complete response.

Q:  If fillable forms are not mandated, then how can it be a ‘high’ severity in the validation criteria? The concern is once FDA moves to an automated technical validation, the submission would be rejected.

A:  The validation errors are posted by the FDA. If any criteria is considered troublesome, it would be best to bring that to the FDA’s attention.

Q:  This question is in regards to the validation error triggered by the eCTD application number not matching the folder name.  It is my understanding that the FDA includes a three letter prefix in their eCTD folder names, for example ind777777. Will this prefix trigger a validation error?

A: The validation checks the last 6 characters in the application folder.

Q: Does submitting a fillable form without electronic signature and  a scanned form with signature still leverage advantages of using fillable forms?

A: Yes, The system looks for the fillable form.

Q: Currently, the Annual Report form will not allow for a leading 0, but instead changes the application number to include a comma. Does FDA plan to update this form, or is the best practice now to use a 356h fillable form and select the “annual report” option?

A: We will provide this answer on this blog shortly.

Q: Are the new validation criteria linked to the new planned version of the FDA Module 1? Is there a draft specification for the new US M1 available?

A: The validation criteria is NOT linked to new M1. I will follow up with a blog post on where the new M1 draft specification is posted.

Thank you again to all of those who participated in the webinar. For your reference, the webinar slides are now available for download here.

We look forward to seeing you at future events.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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