ESG Submission Process: High Level Technical Validation

Submissions can be sent to the FDA Electronic Submissions Gateway (ESG) via a web interface also known as WebTrader or by a gateway to gateway connection known as AS2.  For the detailed process of a submission as it moves through the Gateway, click here.  The steps below detail the process of a submission as it is validated by its respective FDA Center:

Center for Drug Evaluation and Research (CDER)

CDER retrieves the submission from ESG and checks the following:

• The presence of a us_regional.xml file
• Valid application number
• Non-duplicate sequence number for the application
• Submission is NOT a single file
• Application type/number in the form (e.g. 356h, 1571) matches application/type in the us_regional.xml

If initial validation is successful, the eCTD validation tool is used to check for any high errors (as listed in the “Specifications for eCTD Validation Criteria”) in the eCTD submission.

 

Center for Biologics Evaluation and Research (CBER)

CBER retrieves the submission from ESG and checks the following:

• The presence of a us_regional.xml file
• Valid application number
• Non-duplicate sequence number for the application
• Submission is NOT a single file
• Application type/number in the form (e.g. 356h, 1571) matches application/type in the us_regional.xml

If initial validation is successful, the eCTD validation tool is used to check for any high errors (as listed in the “Specifications for eCTD Validation Criteria”) in the eCTD submission.