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  1. Electronic Regulatory Submission and Review

eCTD Resources

Electronic submission using the Electronic Common Technical Document (eCTD) can involve the use of several resources. These resources will help provide direction in the submission process.  


FDA Guidances

Final guidances related to eCTD:

Draft guidances related to eCTD: 

eCTD Submission Standards Catalog

For a listing of Specifications, Supportive Files, M1 versions 1.3 and 2.3 documents related to eCTD, please refer to eCTD Submission Standards (XLS - 76KB)  or eCTD Submission Standards (PDF - 108KB)

Data Standards Catalog

Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog on the Study Data Standards Resources page.

Technical Conformance Guide

eCTD Technical Conformance Guide (added 11/30/2018) (PDF - 345 KB)

Provides specifications, recommendations, and general considerations on how to submit eCTD-based electronic submissions to CDER or CBER.

Validation Specifications

Specifications for eCTD Validation Criteria (PDF - 460KB)

Information required to validate an eCTD submission.

 

Fact Sheets

Additional Resources

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