The End of Paper Submissions

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After having worked its way through various draft stages and legal interpretations, the final binding guidance mandating certain submission types be sent to FDA in the specified electronic format is a reality.

The document, Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications – was published Tuesday, May 5, 2015.

You can read the full text of the guidance document here

During the FDA Update delivered Monday, May 11 at the DIA eRI conference, representatives of the Agency stressed that this wasn’t your average guidance document in that its’ provisions are legally enforceable and not just good practice. You’ll notice the word “must” appears in the binding guidance where “should” was used previously to indicate a best practice.

Transition from Paper to eCTD

The release of the final binding guidance now sets in motion a 24-month timeline. Using the May 5th date as a guide, it stands to reason that submission types NDA, ANDA, BLA, and master files must be submitted in eCTD format beginning May 5, 2017. IND submissions would be required May 5, 2018.

Interestingly enough the electronic submission mandate and other FDA modernization efforts were linked to an Executive Branch memorandum dated August 24, 2012. The directive asked all Federal agencies to take the necessary steps so that all permanent records were managed electronically by 2019.

With currently exempted submissions like non-commercial and emergency use INDs mentioned among the FDA’s long-term wish list of electronic initiatives, is the ‘End of Paper’ an attainable goal?

Author: Brandon Underwood

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