eCTD Important Notices
- FDA will accept submissions using the new M1 Specifications (v.2.3) as of June 15, 2015 (added 5/8/2015)
- Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (added 5/5/2015)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription Drugs (added 4/22/2015)
- FDA has published addendum 2 to the M1 documents (added 4/8/2015)
- FDA is requesting comments on the draft eCTD v4.0 specifications (added 3/25/2015)
- FDA is seeking sample submissions for the new eCTD Module 1 Specifications (v2.3) to supplement testing of processing, review, and tracking systems (added 2/11/2015)
- FDA has updated the expected implementation date for the M1 New Specifications (v2.3) to the 3rd Quarter of FY 2015 (which ends June 30, 2015) (added 12/11/2014)
- FDA has published an update to PDF specifications for electronic submissions (PDF) (updated 09/14/2014)
- Draft eCTD Guidance - Not for implementation - Public comment period closes September 23, 2014 (added 07/2014)
- FDA has published revisions to the M1 documents (added 2/10/2014)
- Submission of periodic safety reports to the eCTD (added 07/2013)
- FDA has published a new document, Specifications for File Format Types Using eCTD Specifications (PDF) (added 04/2013)
- FDA has completed testing and will deploy upgrades to its validation software in April 2013 (added 02/2013)
- Submission of Advertising, and Promotional Labeling to CDER/OPDP (added 04/2012)
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.
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.
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".
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