FDA Drafts Guidance for Regulatory Submissions in Alternate Electronic Format

The US Food and Drug Administration (FDA) issued draft guidance providing recommendations on an alternate electronic format for submissions that qualify for an exemption or waiver from electronic common technical document (eCTD) requirements.

Background:

This guidance comes much less than a month after FDA finalized the seventh revision to its guidance on making regulatory submissions in eCTD format to indicate when an exemption or waiver from eCTD requirements is warranted.

According to that guidance, FDA may grant for certain positron emission tomography (PET) drugs and Type II DMFs for PET drugs for a long-term waiver from eCTD requirements. In some unique and rare circumstances, it may grant for short-term waivers for other submissions and Type III drug master files (DMFs) and noncommercial investigational new drug applications (INDs) are exempted from eCTD requirements.

Guidance:

In the new draft guidance, FDA describes how to submit applications and other regulatory submissions in alternate electronic format, without extensible markup language (XML) backbone. Even though the alternate electronic format utilizes the same folder structure found in eCTD submissions, it does not include XML and other specific documents needed for electronic display and does not require specialized software.

The guidance describes the folder structure and organization of the alternate electronic format and providing recommendations to sponsors that plan to make submissions using the format. And it also applies to submissions and applications that are exempted or obtained a waiver from eCTD requirements, including new drug applications (NDAs) and abbreviated new drug applications (ANDAs), as well as certain DMFs, INDs and biologics license applications (BLAs).