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  6. Electronic Common Technical Document (eCTD) v4.0
  1. Electronic Regulatory Submission and Review

Electronic Common Technical Document (eCTD) v4.0

The documentation and links on this webpage provide information on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

FDA eCTD v4.0 Implementation Status

CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page.

Future implementation phases will address forward compatibility for existing v3.2.2 applications and two-way communication.

eCTD Submission Standards

For a listing of eCTD v4.0 Implementation Guides, Specifications, Validations, Technical Conformance Guide, and Supportive Files, please refer to the eCTD Submission Standards for eCTD v4.0 and Regional M1.

Send a Sample v4.0 Submission to FDA

There is an optional process to submit a sample eCTD v4.0 and/or standardized data sample for feedback. Currently only new application samples will be evaluated. Future phases will include evaluation of forward compatibility. For information on the process of submitting a sample, please refer to Submit an eCTD v4.0 or Standardized Data Sample to the FDA.

Additional Resources: ICH eCTD v4.0 Step 4 – Implementation Package

The ICH eCTD v4.0 Implementation Package, regional Implementation timeline information, and related files are available for download from the ICH eCTD v4.0 Step 4 page.

To submit comments or questions on the ICH eCTD v4.0 Implementation Package please see the Change Control section on the ICH eCTD v4.0 page.

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