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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 eCTD resources, including FDA industry guidances, submission standards, a data standards catalog, eCTD v4.0 implementation, and more, will help provide direction in the submission process.

FDA eCTD Guidances

Final Guidances

  1. Electronic Submissions for Promotional Materials (April 2022) - Explains how to submit promotional materials electronically in Module 1 of the eCTD.

  2. eCTD Format for Drug Applications (Sept. 2024) - Outlines how to organize and submit electronic content for drug applications under the FDC Act.

  3. Receipt Dates for Electronic Submissions (Feb. 2014) - Details how the FDA assigns receipt dates to electronic submissions for drug products.

  4. Integrated Summaries in the CTD (April 2009) - Clarifies where to include the integrated summaries of effectiveness and safety in CTD submissions.

Draft Guidances

  1. Formal Meetings with FDA for Drug Development (Sept. 2023) - This draft guidance offers recommendations for formal meetings between the FDA and sponsors/applicants regarding the development and review of drugs and biologics.

eCTD Submission Standards

For a listing of eCTD v3.2.2 Specifications, Supportive Files, Validations, Technical Conformance Guide, and M1 documents related to eCTD, refer to the eCTD Submission Standards for eCTD v3.2.2 and Regional M1.

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

Data Standards Catalog

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

eCTD v4.0 Implementation

To prepare submissions in eCTD v4.0 format to the FDA, additional documentation is available.

Information relating to the future implementation of forward compatibility from v3.2.2 to v4.0 will be available for planning purposes. Refer to the eCTD v4.0 webpage for more information.

Additional Resources

  • Important Notices Archive
    A list of important notices related to eCTD submissions.
  • FDA Forms
    This collection includes forms for applications and submissions, reports and accountability, certifications, and inspections.
  • SSR DMF Technical Conformance Guide
    This document provides specifications, recommendations, and general considerations on how to submit Risk Evaluation and Mitigation Strategy (REMS) submissions to a Type V Drug Master File (DMF) that is being used for a Shared System REMS (SSR).
  • Structured Product Labeling Resources
    The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
  • FAERS Electronic Submissions
    The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA.
  • Regulatory Guidance Drug Registration and Listing
    Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA.
  • Recent FDA eCTD Presentations
    Refer to presentation slides from FDA speaking engagements.
  • CDER SBIA Webinars
    View archived Small Business Industry Assistance (SBIA) webinars.
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