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USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements.

These recommendations pertain to the format of the content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).

Sponsors and applicants who receive an exemption or a waiver from filing in electronic common technical document (eCTD) format under section 745A(a) of the FD&C Act should still provide those exempted or waived submissions electronically.

Although the alternate electronic format utilizes the same folder structure found in eCTD submissions, it does not include XML and other specific files needed for electronic display.

The alternate electronic format does not require specialized software. Commercial off-the-shelf software or other methods may be used to either build or view the submission but like eCTD, the alternate electronic format should follow the FDA technical specification The Comprehensive Table of Contents Headings and Hierarchy.

Also, the alternate electronic format should follow the eCTD Technical Conformance Guide (e.g., Section 3.1.2 Cover Letter and Reviewers Guide).

To know How to Submit in an Alternate Electronic Format (without XML backbone) and understand on Pre-Submission Considerations, Submission Structures like Granularity, Files, and Folders, File Formats and Datasets and Study Information etc, CLICK this LINK.


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