Submit Using eCTD
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:
Electronic Submission Resources:
For CDER submission related questions, email esub@fda.hhs.gov
For CDER study data-related questions, email edata@fda.hhs.gov
For CBER submission related questions, email esubprep@fda.hhs.gov
For CBER study data-related questions, CBER-edata@fda.hhs.gov
Tip: Plan and prepare early for electronic submission and obtain clarification from 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.
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 and can provide valuable feedback. This is separate from the test submissions made as part of the ESG account signup process.
Please refer to the following pages:
- Submitting standardized study data
- Submitting eCTD v4.0 (may include standardized study data sample)
Tip: Submit the sample early to allow time to make adjustments prior to final submission.
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.
Tip: Review and validate your eCTD submission prior to submitting to avoid submission errors. See the Specifications for eCTD Validation Criteria (PDF - 254 KB) or Specifications for eCTD v4.0 Validation Criteria for more information.
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.