When submissions arrive in eCTD format, reviewers can easily find and access the information they need to review, whether it was part of the original submission or added later by the product sponsor.
Electronic submissions make it easier for FDA to review data, approve new drugs, and monitor drugs after they go on the market. Using eCTD also simplifies the process for submitters, because it is the same format used by drug regulatory agencies in other countries.
If you are new to eCTD, follow these steps to get started:
Learn about eCTD
Review the Electronic Submission Resources
Submit Fillable Forms and Compliant PDFs
Request an Application Number
Register for an Electronic Submissions Gateway Account
Send a Sample Submission to FDA
Submit Via the Electronic Submission Gateway
- NEW eCTD Submission Requirements: What You Need to Know fact sheet (PDF - 224KB)
- Recent eCTD presentations by FDA staff
- CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Electronic Submission Requirements for ANDAs: Are You Ready? – November 21, 2016
Tip: Build and maintain a knowledge base by staying informed about existing, new, and updated eCTD-related tools and information.
- FDA Guidances
- eCTD Submission Standards Catalog
- Data Standards Catalog
- Technical Conformance Guide
- Validation Specifications
- Fact Sheets
- Additional Resources
Tip: Plan and prepare early for electronic submission and obtain clarification from the appropriate Review Division in advance.
For submission-related questions, email email@example.com
For study data-related questions, email firstname.lastname@example.org
Submit only FDA fillable forms (e.g., 1571 or 356h) with digital signatures to enable automated processing of the submission, which delivers your submission to the review teams quickly and efficiently. Do not submit scanned images of FDA fillable forms. See the FDA Forms.
PDF files should be searchable and compliant with the ICH M4 Granularity Annex (PDF - 125 KB) and the FDA PDF Specifications (PDF - 170 KB). Also, ensure that documents and files prepared by third parties are compliant with these specifications.
Tip: Have questions? Ask for clarification by writing to email@example.com or the appropriate Review Division in advance.
Before you can submit an application to FDA, you will need a pre-assigned application number:
Tip: Plan accordingly and avoid rushing when submitting to help avoid mistakes. What may seem like a small error can have big implications (such as a wrong digit in your application number).
The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to FDA.
Registering to use the FDA ESG involves a sequence of steps to be conducted for all submitters and types of submissions. It is best to start well in advance of when you plan to make a submission.
The account creation process includes a testing phase designed to ensure that the FDA ESG can successfully receive your electronic submission and that the electronic submission is prepared according to published guidelines. The testing phase is done through the FDA ESG test system. Once the submitter’s test submission has passed the testing phase, an account will be set up to allow submissions through the FDA ESG production system.
All relevant information, including detailed descriptions of the steps and contact information for requests and assistance, can be found on the FDA ESG website.
- NEW Getting Started: Creating an ESG Account fact sheet (PDF - 209 KB)
Tip: Allow plenty of time to complete the multi-step account creation process and become familiar with the ESG interface.
Submitting a sample eCTD or standardized data sample is optional, but can provide valuable feedback. This is separate from the test submissions made as part of the ESG account signup process. For information on the process of submitting a sample, please refer to the Sample Submission Process.
Tip: Submit the sample early to allow time to make adjustments prior to final submission.
As of the time frames stated above, eCTD submissions sized 10 GB or smaller must be submitted via the FDA Electronic Submissions Gateway (ESG). Most submissions fall within these limits.
Submitters are strongly advised to obtain ESG accounts as soon as possible, as the signup process can take some time.
- NEW FDA Electronic Submissions Gateway fact sheet (PDF - 208 KB)
Tip: Review and validate your eCTD submission prior to submitting to avoid submission errors. See the Specifications for eCTD Validation Criteria (PDF - 254 KB) for more information.
If you have questions for CDER, please contact the CDER Electronic Submission (ESUB) Support Team at firstname.lastname@example.org.
If you have questions for CBER, please contact the CBER ESUB Support Team at email@example.com.