FDA issues final guidance on providing regulatory submissions in alternate electronic formats

The US Food and Drug Administration on Thursday issued a final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.
 
The guidance contains few changes from the draft issued in March 2020. (RELATED: FDA Drafts Guidance on Alternate Electronic Formats, Announces Support for New Data Standards, Regulatory Focus, 10 March 2020). In its final form, the guidance clarifies where the table of contents should be located and provides an example of the folder structure, according to an announcement  in the Federal Register.
 
The guidance applies to new drug applications and abbreviated new drug applications, as well as to certain drug master files, biologics license applications and investigational new drug applications submitted to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.
 
The guidance addresses how to submit electronically in an alternate electronic format without an extensible markup language (XML) backbone. It covers how to submit FDA forms; pre-submission considerations; the structure of the submission, including the level of granularity, files and folders; file formats; and datasets and study information.
 
No specialized software is needed to use the alternate electronic format; commercial off-the-shelf software may be used to build or view submissions.
 
All document and data files should be placed in a main folder using the application type and number. FDA incorporated a suggestion submitted by AstraZeneca during the draft guidance comment period to add a table of contents with hyperlinks and bookmarks in numerical order to more easily navigate the files contained in the submission.
 
Electronic submissions should solely be made up of FDA fillable forms, and not scanned forms.
 
The level at which the submission content is broken out into separate files should be aligned with the International Council for Harmonization (ICH) M4 guideline on the organization of the CTD or the ICH M2 specification guidance on change requests for the eCTD.
 
For the listing of headings and hierarchy, sponsors should use FDA’s technical specification for the comprehensive table of contents and hierarchy. Similarly, files within an alternate electronic submission should conform to the technical specification for eCTD specifications, and PDF files should adhere to the relevant technical specification.
 
Electronic submissions should be transmitted via the FDA’s Electronic Submissions Gateway (ESG) if submissions are 10 gigabytes or smaller. Larger submissions should follow the eCTD specifications for electronic submission transmission.
 
The final guidance includes a list of relevant technical specifications and FDA guidance documents.
 
Comments are being accepted anytime.
 
FDA’s guidance on electronic submissions