Drugs

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 - 93KB) New! or eCTD Submission Standards (PDF - 97KB) New!
 

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

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

Validation Specifications

Information required to validate an eCTD submission.
 

Fact Sheets

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. 
  • Technical Rejection Criteria for Study Data (PDF - 92KB) New!
    Study Data Standards are required in clinical and nonclinical studies. Technical rejection criteria is being added to the existing eCTD validation criteria. 
  • Electronic Common Technical Document (eCTD) v4.0
    To prepare for the FDA implementation of the eCTD v4.0 standard, FDA is making the documentation available for download and should be used for implementation planning purposes only. 
  • 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. 
  • FDA Adverse Events Reporting System (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.
    This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. 
  • 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. 
  • Electronic Common Technical Document (eCTD) Course
    This course will walk you through the essential steps of submitting electronic submissions to the Center for Drug Evaluation and Research (CDER), and can serve as a resource for questions about the submission process. 
  • Recent FDA eCTD Presentations
    Refer to presentation slides from FDA speaking engagements. 
  • CDER Small Business Industry Assistance (SBIA) webinars
    View archived SBIA webinars.

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Page Last Updated: 04/06/2017
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