The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. Beginning May 5, 2017 submission types NDA, ANDA, BLA and Master Files must be submitted in eCTD format. Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018. Submissions that do not adhere to the requirements stated in the eCTD Guidance will not be filed or received.
As of the timeframes stated above, submissions sized 10GB and under must be submitted via the FDA Electronic Submission Gateway. Because most submissions fall within these limits, submitters are strongly advised to obtain Gateway accounts as soon as possible. You must submit electronic submissions using the version of eCTD currently supported by FDA. The version of eCTD currently supported is specified in the Data Standards Catalog.
FDA has exempted all submissions regarding noncommercial INDs from the requirements under section 745A(a). Although these submissions will be exempt, FDA also accepts their submission electronically. For additional information on the guidance, including additional exemptions, please refer to the Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications.
- Technical Rejection Criteria for Study Data (PDF - 92KB added 11/14/2016)
- Update to eCTD Technical Conformance Guide (PDF - added 10/19/2016)
- Update to PDF Specifications (PDF - added 10/3/2016)
- Transmission Specification version 1.6 (added 3/4/2016)
eCTD Documentation and Resources
If you have not previously submitted in eCTD format, or have an electronic submissions gateway account, an ESG account and sample submissions are needed before your initial submission.
- Step 1: eCTD Basics and Getting Started
- Step 2: Electronic Submissions Gateway
- Step 3: Submit a Sample eCTD or Standardized Data Sample
- Step 4:
- Step 5: Study Data Standards Resources
The FDA periodically publishes guidances on many matters, including eCTD. Those related to eCTD can be found below:
- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications (PDF)
- Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Receipt Dates (PDF)
- Final Guidance for Industry: Integrated Summaries of Effectiveness and Safety – Location within the CTD (PDF)
- Draft Guidance for Industry: Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs (PDF)
For presentations, webinars, conference dates and other related information, see below:
For fact sheets on eCTD requirements and ESG submission, see below:
- eCTD Submission Requirements: What You Need to Know
- New Requirements for Electronic Submission of DMFs
- FDA Electronic Submissions Gateway
- Getting Started: Creating an ESG Account
For information regarding specific eCTD submissions:
- Important Notices Archive
- FDA Forms
- Technical Rejection Criteria for Study Data (PDF)
- Electronic Common Technical Document (eCTD) v4.0
- Structured Product Labeling Resources
- FDA Adverse Events Reporting System (FAERS) Electronic Submissions
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
- Regulatory Guidance Drug Registration and Listing
- If you have questions for CDER, please contact CDER ESUB at firstname.lastname@example.org.
- If you have questions for CBER, please contact CBER ESUB at email@example.com.