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U.S. Department of Health and Human Services

Drugs

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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.

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. This step can provide valuable feedback. 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 and obtain clarification from esub@fda.hhs.gov or the appropriate Review Division in advance.
  • Build and maintain a knowledge base:
    • Understand the electronic submission process
    • Review the most recent eCTD presentations by FDA staff so you’re aware of current recommendations and common issues
    • Be knowledgeable about what FDA resources (websites, guidance documents, etc.) are available and what email addresses should be used for obtaining information and clarification
    • Learn where and how submission information is referenced in an eCTD
    • Stay informed of existing, new and updated eCTD related information
  • Ensure searchable PDF format is used that is compliant with the ICH M4 Granularity Annex and FDA PDF Specification and ensure documents and files provided by CROs also are compliant with Specifications.
  • Plan accordingly and avoid rushing when submitting to help avoid mistakes. What may seem like a small error can have big implications (such as a wrong digit in your application number)
  • Utilize a procedure to verify that your submission is complete and accurate
  • Use the Electronic Submissions Gateway and FDA fillable forms with digital signatures which allows automated processing to quickly and efficiently route your submission to the review teams.
It’s important to view and validate your eCTD submission prior to submitting; see the eCTD validation specifications for more information. 
If you have questions, please contact the CDER Electronic Submission (CDER ESUB) Support Team at esub@fda.hhs.gov.