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# Guide on Drug eSubmissions Using cCTD Specs
- URL: https://www.fdaweb.com/guide-on-drug-esubmissions-using-cctd-specs/
- Published: 2020-02-21T12:00:00.000Z
- Updated: 2026-09-14T16:04:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146147

FDA has released a [revised guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-certain-human-pharmaceutical-product-applications-0?ref=fdaweb.com) on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission types. It also references several technical specification documents and the Electronic Common Technical Document Conformance (eCTD) Guide, which provide additional details about organizing content for electronic submissions.

The guidance specifies that all Type 3 drug master files will qualify for an exemption from submitting in the eCTD format. This is in addition to the current exemption for noncommercial INDs. Additionally, the agency says it will grant long-term waivers from the requirement to submit drug master files in eCTD format for certain positron emission tomography drugs. “In certain extraordinary circumstances, FDA may grant a short-term waiver from eCTD submission requirements,” it says.