FDA eCTD 指南（正式版 Rev 8）及 eCTD v3.2.2/v4.0 提交标准与实施通知

Quick Links

• eCTD Guidance (Final, Rev 8)(PDF -11 KB)
• eCTD Submission Standards for eCTD v3.2.2 and Regional M1
• eCTD Submission Standards for eCTD v4.0 and Regional M1
• FDA Data Standards Catalog and Study Data Resources
• eCTD v3.2.2 Technical Conformance Guide (PDF - 546 KB)
• eCTD v4.0 Technical Conformance Guide
• Drug Master Files (DMFs)
• eCTD 4.0 Implementation

Notices

• FDA FR Notice on supporting v4.0 Forward Compatibility submissions
• FDA FR Notice on high severity eCTD validation for v3.2.2 and v4.0
• FDA FR Notice on supporting v4.0 submissions
• Past Notices

The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Please refer to the eCTD Guidance for the complete details to meet the eCTD requirement.

Important Dates

Per the FDA Federal Register Notice, CDER and CBER are supporting Forward Compatibility for NDA, BLA, ANDA, IND, and MFs beginning October 16, 2026. Applications originally submitted using eCTD v3.2.2 may now use Forward Compatibility to continue in eCTD v4.0. FDA will provide advance notice of when the Agency will begin supporting electronic submission only in eCTD v4.0. Please see the FR Notice, Data Standards Catalog, eCTD v4.0 Submission Standards for details.

Visit the Submit Using eCTD page to learn how to submit an application using eCTD and obtain an ESG account.
To view all eCTD Submission Resources, visit our eCTD Resources page.

Types of Submissions Subject to eCTD Requirement

Electronic submission requirements will apply to the following types of submissions to CDER/CBER:

• NDAs
• ANDAs
• BLAs
• Commercial IND applications (for products that are intended to be distributed commercially)
• All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
• Master files, such as DMFs, which are considered to be submissions to an IND, an NDA, an ANDA, or a BLA

Electronic submission standards will be optional but encouraged for the following categories:

• Noncommercial INDs, such as investigator-sponsored INDs and expanded-access INDs
• Submissions for blood and blood components, including source plasma
• Submissions for Type III Master Files

Current Versions and Updates

• Electronic submissions must use a version of eCTD currently supported by FDA, either v3.2.2 or v4.0, which is specified in the FDA Data Standards Catalog. Updates to the standard will be announced on the FDA website and published in the Federal Register. The notices will include the date on which the new versions will go into effect.
• For a listing of Specifications, Supportive Files, and versions related to eCTD, please refer to
  • eCTD Submission Standards for eCTD v3.2.2 and Regional M1
  • eCTD Submission Standards for eCTD v4.0 and Regional M1

Stay Connected

• If you have questions for CDER, please contact the CDER Electronic Submission (ESUB) Support Team at esub@fda.hhs.gov
• If you have questions for CBER, please contact the CBER ESUB Support Team at esubprep@fda.hhs.gov.