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 FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now. Effective September 15, 2021, the FDA will begin enforcing the TRC for study data.