eCTD Basics and Getting Started

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. Follow the steps below prior to submitting an eCTD to the FDA.

Refer to the Published Specifications and Guidance Documents

• Visit the FDA eCTD website to review specifications and guidance documents
• View recent eCTD presentations by FDA staff
• Refer to the Comprehensive Table of Contents Headings and Hierarchy 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 several times a year. 

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)

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 Electronic Submission Support Team at ESUB@fda.hhs.gov.

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