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Providing Regulatory Submissions in Alternate Electronic Format – US FDA

The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for submitting applications that are exempt from electronic common technical document (eCTD) filing requirements.

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1).

These recommendations pertain to the format of 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).

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.

The following is a list of FDA technical specification documents referenced in this guidance:

1. The Comprehensive Table of Contents Headings and Hierarchy

2. eCTD Technical Conformance Guide

3. Specifications for File Format Types Using eCTD Specifications

4. Portable Document Format (PDF) Specifications

5. Transmitting Electronic Submissions Using eCTD Specifications

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