FDA sets deadline for study data technical rejection criteria

Regulatory NewsRegulatory News
| 28 July 2021 | By Michael Mezher 

The US Food and Drug Administration (FDA) has set a deadline for when it will begin refusing to file or to receive electronic submissions that fail to meet the agency’s established electronic common technical document (eCTD) validation criteria.
Beginning 15 September 2021, FDA says it will “reject submissions that contain any high validation errors included in the [technical rejection criteria] TRC.” The new effective date for the technical rejection criteria was announced in a Federal Register notice scheduled for publication on 29 July. The technical rejection criteria are applicable to submissions to both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
In its guidance, Providing Regulatory Submissions in Electronic format – Standardized Study Data, FDA explains that any “submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless they have an exemption or waiver from the electronic submission requirements.”
The agency maintains a list of acceptable standards in its Data Standards Catalog, as well as a list of technical rejection criteria for study data first published in 2016. At the time it was released, FDA said it would provide industry 30 days’ notice prior to the technical rejection criteria becoming effective. (RELATED: FDA offers technical rejection criteria for study data, Regulatory Focus 11 November 2016)
FDA explains that technical rejection criteria are “automated validations” performed by both CDER and CBER inbound processing systems against the agency’s Specifications for eCTD Validation Criteria.
In its latest technical rejection criteria for study data list, FDA details several validations and explains the error that could cause the validation to trigger and the corrective action to resolve the issue. For instance, FDA says that Validation 1734 may arise if the submitter did not include a dataset named “ts.xpt” with the information on study start date for each study in Module 4, section 4.2, or in Module 5, section 5.3 of the eCTD. The associated corrective action would be to resubmit with the appropriate dataset.
Federal Register Notice


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