Drugs
Electronic Common Technical Document (eCTD)
Important Note: 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 |
Important Note: Submission of Periodic reports to the eCTD - avoid incorrect submission of ICSRs Periodic1 reports consist of two parts; a descriptive portion and the Individual Case Safety Reports (ICSRs); only the descriptive portion of the Periodic may be submitted to the eCTD. Descriptive portion: The acceptable format is the Periodic Adverse (Drug) Experience Report or the ICH-E2C Periodic Safety Update Report (PDF) (allowed with approved waiver); either format may be submitted to the eCTD in module 5.3.6. Firms should indicate in the descriptive portion that the ICSRs have been submitted electronically as XML files to the FDA Electronic Submissions Gateway (ESG) or that FDA 3500A forms have been mailed to FDA’s Central Document Room (CDR). ICSRs, with or without attachments: The acceptable methods of ICSR submission are electronically using ICH E2B standards or by mail using Form FDA 3500A. Submission of ICSRs to the eCTD is not acceptable because these ICSRs are not received in a manner that can be processed into the Adverse Event Reporting System (AERS) database. ----------------------- 1. Periodic adverse drug experience reports or Periodic adverse experience reports, as described in 21 CFR 314.80 and 600.80, respectively. |
eCTD Basics and Getting Started
The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. The FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and we offer the following steps to help smooth the process.
- Review the Published Guidance and Specifications documents below
- View recent eCTD presentations by FDA staff
- Refer to the Comprehensive Table of Contents Headings and Hierarchy (PDF) for information on document location, and for a regulatory and CFR mapping to the CTD (see page 12)
Understand the Various Tools, Software and Training Opportunities
FDA as a government agency does not recommend specific software or tools. Information on tools, vendors, and eCTD preparation firms may be obtained by Internet search. We recommend that you choose eCTD software and tools that allow you to build, validate, and view an eCTD.
In addition, there are several non-profit organizations that sponsor conferences and offer training in eCTD, and FDA regularly participates in these events.
Submit a Sample eCTD to the FDA
Your first step after following the recommendations above would be to submit a sample eCTD for evaluation. For information on the process of submitting a sample, please refer to the Sample Submission Process.
Build Quality into Your Process to Ensure Success
- Plan and prepare early for electronic submission
- Build a knowledge base to understand the electronic submission process and clarify any questions you have on guidance documents
- Ask CROs in advance to provide reports in searchable PDF format compliant with the ICH M4 Granularity Annex and FDA PDF Specification
- Utilize a procedure to verify that your submission is complete and accurate
- Don’t rush when submitting, since what can seem like a small error can have big implications (such as a wrong digit in your application number)
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Take advantage of the Electronic Submissions Gateway and use FDA fillable forms and digital signatures for the fastest processing of your electronic submissions
It’s important to both view and validate your eCTD submission prior to submitting; see the eCTD validation specifications for more information. Review the most recent eCTD presentations by FDA staff so you’re aware of current recommendations.
If you have questions along the way, please do not hesitate to contact the CDER Electronic Submission (CDER ESUB) Support Team at esub@fda.hhs.gov.
eCTD Guidance and Specifications
Electronic Submissions Public Docket 
Request a Pre-assigned Application Number for a Planned eCTD Submission
Guidance Documents
- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications (PDF - 132KB) (June 2008)
- Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98KB) (April 2009)
eCTD Specifications
- FDA eCTD Table of Contents Headings and Hierarchy (PDF - 73KB) (updated 7/6/2005)
- eCTD Backbone Files Specification for Module 1 (PDF - 102KB) (updated 12/13/2006)
- eCTD Backbone File Specification for Modules 2 through 5 3.2.2 (PDF - 726KB) (updated 7/16/2008)
- The eCTD Backbone File Specification for Study Tagging Files 2.6.1 (PDF - 149KB) (6/3/2008)
- Study Data Specifications (PDF - 199KB) (updated 7/18/2012)
- eCTD Validation Specifications Website (12/20/2011)
- Portable Document Format Specifications (PDF - 37KB) (updated 1/20/2012)
- Transmission Specifications (PDF - 35KB) (updated 7/26/2012)
| UTILS | Version | File Name | MD5 Checksum | Support Began | Support Ends |
|---|---|---|---|---|---|
| ICH eCTD DTD | 3.2 | ich-ectd-3-2.dtd | 1d6f631cc6b6357f0f4fe378e5f79a27 | 11/2003 | |
| ICH-STF DTD | 2.2 | ich-stf-v2-2.dtd | 0972c10a4dadf3df5d2f41b2026a4a5c | 8/2003 | |
| US Regional DTD | 2.01 | us-regional-v2-01.dtd | 9d09aa5ffdb44368416e287f9b0ddeeb | 8/2003 | |
| US Regional Stylesheet | 1.1 | us-regional.xsl | b3bdeb93158b2a30faca4d943b89fba4 | 9/2003 | |
| ICH eCTD Stylesheet | 2.0 | ectd-2-0.xsl | 3a07a202455e954a2eb203c5bb443f77 | 11/2004 | |
| ICH STF Stylesheet | 2-2a | ich-stf-stylesheet-2-2a.xsl | 7af15705b92a21ac1a19527cfc504245 | 5/2007 | |
| Valid Values xml | 2.2 | valid-values.xml | 664f584d0631db0414e8789e2a06613b | 8/2008 |
If you have questions, please contact CDER ESUB at mailto:esub@fda.hhs.gov.
Important Related Information
CDER Data Standards Program - Electronic Regulatory Submission and Review (ERSR)
FDA Forms Structured Product Labeling Resources FDA Adverse Events Reporting System (FAERS) Electronic Submissions Regulatory Guidance Drug Registration and Listing CDER Investigational New Drug (IND) Renumbering Formal Meetings Between the FDA and Sponsors or Applicants_PRA (PDF - 95KB)
