eCTD Important Notices

Important Note 02/2014:

FDA has published revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: "The eCTD Backbone Files Specification for Module 1," version 2.3 (which includes the U.S. regional document type definition (DTD), version 3.3); " The Comprehensive Table of Contents Headings and Hierarchy," version 2.3; "Specifications for eCTD Validation Criteria," version 3.1; and "Example Submissions using eCTD Backbone Files Specification for Module 1," version 1.3.  Technical files that support these documents are also available.  Please see the eCTD Data Standards


Important Note 07/2013:

Update 10/05/2015: Removed option for mailing. Submissions are to be made electronically.
Submission of periodic safety reports to the eCTD
Periodic safety reports consist of two parts: a descriptive portion and the individual case safety reports (ICSRs).  Only the descriptive portion of the periodic safety report can be submitted to the eCTD.
Descriptive portion:
Firms can submit the descriptive portion of the periodic safety report in the following formats: the periodic adverse drug experience report, the periodic adverse experience report or, with an approved waiver, either the periodic safety update report or the periodic benefit-risk evaluation report.  The descriptive portion can be submitted to the eCTD in module 5.3.6 and should indicate that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG).
Firms can submit ICSRs electronically using ICH E2B(R) standards via the FDA Electronic Submission Gateway (ESG) or via the Safety Reporting Portal (SRP). Submission of ICSRs to the eCTD is not acceptable because these ICSRs cannot be processed into the FDA Adverse Event Reporting System (FAERS) database.

Important Note 04/2013:

FDA has published a new document, "Specifications for File Format Types Using eCTD Specifications."  Please note that file types specified in this document as acceptable in eCTD subsections within 1.15 Promotional material may not be submitted using the current Module 1 (US Regional DTD v. 2.01), as these subsections do not exist in that version. The file types specified for 1.15 subsections are intended for use in the updated Module 1 (US Regional DTD v. 3.1 or higher), once it is implemented.


Important Note 02/2013:

FDA has completed testing and will deploy upgrades to its validation software in April 2013. The Specifications for eCTD Validation Criteria, Version 2.1 will be in effect no later than April 30, 2013.  The updated validation software will allow support for Valid Values v. 3.0, which has been posted to the eCTD website under "eCTD Supportive Files".


Important Note 04/2012:

CDER's Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications - DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway at this time. If received, these submissions will be rejected by CDER. For information about submissions to OPDP, please refer to the following web page: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm

Page Last Updated: 10/07/2015
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