Electronic Common Technical Document (eCTD)

FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process. eCTD Basics, Getting Started and Sample Submissions

Request a Pre-assigned Application Number for a Planned eCTD Submission

Request a Waiver: NOTICE: Important instructions regarding electronic submissions, effective January 1, 2008 

Guidance Documents

• Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications [PDF] (June 2008)
• Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [PDF] (April 2009)

eCTD Specifications

• FDA eCTD Table of Contents Headings and Hierarchy [PDF] (updated 7/7/2005)
• eCTD Backbone Files Specification for Module 1 [PDF] (updated 12/13/2006)
• eCTD Backbone File Specification for Modules 2 through 5 3.2.2 [PDF] (updated 7/16/2008)
  • Clarification for question #10 of "ICH M4: The CTD -- Efficacy Q&As" on submitting integrated summaries of safety and effectiveness (ISS/ISE) in the eCTD format (9/12/2006)
• The eCTD Backbone File Specification for Study Tagging Files 2.6.1 [PDF] (6/3/2008)
• Study Data Specifications [PDF] (updated 8/7/2007)
• eCTD Validation Specifications (3/10/2008)
• Portable Document Format Specifications [PDF] (6/4/2008)
• Transmission Specifications [PDF] (updated 8/27/2009)

If you have questions, please contact CDER ESUB at mailto:esub@fda.hhs.gov

Important Related Information:

• Recent FDA Presentations
• FDA Forms
• Structured Product Labeling (SPL)
• Information on Submitting Postmarketing Individual Case Safety Reports
• Electronic Regulatory Submissions and Review (ERSR website)
• FDA’s Electronic Drug Registration & Listing System
• CDER IND Renumbering
• Information Packages for Meetings