FDA Pushes For Broader Electronic Filings Than Required By Statute
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency’s draft guidance for electronic submissions of pharmaceutical applications encourages sponsors to also submit manufacturing and promotional material electronically.
FDA is encouraging sponsors to submit drug master files as well as advertising and promotional materials in electronic format even though they are not required to do so.
The agency recently issued a draft guidance for providing pharmaceutical product applications electronically. The FDA Safety and Innovation Act signed into law last year requires sponsors to submit new drug applications, abbreviated new drug applications, biologics license applications and investigational new drug applications in electronic format.
The statute does not apply to master files and advertising and promotional labeling materials. However, the guidance says “FDA accepts and strongly encourages” companies to submit them electronically.
With regard to advertisements and promotional labeling material, the guidance says each promotional piece should be provided as an individual PDF file. FDA adds that it should be able to view the entire layout at one time when writing or images cover more than one page. For three-dimensional objects, the guidance says sponsors should submit a digital image of the object in sufficient detail to allow FDA to review it.
FDA notes that INDs for products that are not intended to be distributed commercially are exempt from the electronic submission requirement. But the guidance says the agency “strongly encourages sponsors to submit such INDs electronically.”
The guidance says FDA currently can process, review and archive electronic submissions made using the electronic common technical document (eCTD) specifications. It calls for materials to be submitted in eCTD version 3.2.2 format.
FDA announced the availability of the draft guidance, “Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,” in a Federal Register notice. Comments on the document are due by March 4.
The document supersedes a previous guidance FDA issued in October 2005 and revised in April 2006 and June 2008.
“This Guidance Contains Both Binding And Nonbinding Provisions”
The guidance also notes the timeframe for meeting the electronic filing requirements. NDA, ANDA and BLA submissions must be submitted in electronic format 24 months after publication of the final version of the draft guidance and IND submissions must be submitted electronically 36 months after the final guidance issues.
An FDA official noted at a meeting last year that it anticipates that NDAs, ANDAs and BLAs will be submitted electronically as early as February 2016 and INDs as early as February 2017 (Also see "FDA Starts Electronic Submissions Countdown Clock, Plans “Mama Guidance”" - Pink Sheet, 30 Oct, 2012.).
The guidance states that if the filings are not submitted electronically and they are not in a format that FDA can process, review and archive, the agency will not file them.
The guidance provides detailed information on how to submit materials electronically, including document granularity and table of contents heading. It also addresses the submission of paper copies.
“When providing applications in electronic format using the eCTD backbone files, paper copies of the application, including review copies and desk copies, should not be sent,” the guidance says. It notes that an exception would be submission of paper copies of meeting briefing materials.
Guidance documents routinely state that they should be viewed as recommendations unless specific regulatory or statutory requirements are cited. “FDA is not including this standard language in this guidance because it is not an accurate description of all the effects of this guidance,” the document states. “This guidance contains both binding and nonbinding provisions.”