FDA is planning to introduce new eCTD validation criteria it will use to enforce requirements for clinical and non-clinical study data submitted electronically.
The study data validation errors (2 High, 2 Medium) will apply to the following eCTD sections – 4.2 Study Reports and 5.3 Clinical study reports and related information. FDA is asking sponsors to submit a Trial Summary dataset (TS.xpt) for these sections.
Here are descriptions of the new validation specifications.
These requirements pertain to submission of clinical and non-clinical data for studies initiated after December 17, 2016 if you’re filing NDAs, BLAs, and ANDAs. For commercial INDs, the requirement starts after December 17, 2017. In the event an original submission was filed before the requirements went into effect, subsequent submissions (amendments, supplements, and reports) to these types of applications still must meet the requirements.
Submissions that fail to meet these requirements are subject to technical rejection. The FDA may refuse to file (RTF) NDAs and BLAs. ANDAs would receive a refuse to receive (RTR) designation. FDA has left some wiggle room for manual interpretation of the validation criteria based on language in the notice posted on October 3, 2016.
“Although CDER and CBER can RTF or RTR submissions that do not conform to the required standards, we will implement a process to assess high-level study data standards conformance at the time the submission is submitted and validated. The criteria to be used to assess conformance are listed in the tables below. If the submission fails these criteria, it will be rejected and the sponsor will be notified.”
As is customary, FDA will use its eCTD website to give industry 30 days’ notice prior to the new validation specifications going into effect.