The FDA's Technical Rejection Criteria For Study Data: Does Your eCTD Submission Comply?

By Annette F. Arlinghaus, Director, Regulatory Operations

When a submission is sent through the FDA’s Electronic Submissions Gateway (ESG), it goes through an automated check of many validation rules, as specified in the Electronic Common Technical Document (eCTD) submission standards guidance. This validation check determines if the submission is uploaded into the FDA’s system, or if it is technically rejected.

To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the agency developed the technical rejection criteria (TRC) for study data and began enforcing the TRC for study data in September 2021.