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New upcoming eCTD validation checks at USFDA

Posted on March 22, 2021

On March 10, 2021, the USFDA announced that they would begin to enforce the new eCTD validation checks on September 15, 2021. From then on, the USFDA could start rejecting submissions that do not conform with the Technical Rejection Criteria (TRC) formulated in the new eCTD validation criteria (v3.9) with error codes 1734, 1735, 1736, and 1789 for study data. In addition, the eCTD validation criteria for both CBER and CDER are starting to differ significantly from each other.

To support you in this, the eValidator with the new validation profiles (v3.9) will already report non-compliances on study data, although the FDA will not reject them before September 15, 2021. There are two profiles: one for CBER and one for CDER. To be able to select the new profiles, you need to install the Regulatory Update Package (03-2021 | 1.6.3.2) for LORENZ eValidator which was released on March 22, 2021.

For LORENZ docuBridge’s built-in eValidator, the new validation profiles (v3.9) will be available automatically with the next docuBridge 21.1 release at the end of April 2021. It features an additional envelope property to specify the Center (CBER or CDER), so that the appropriate eValidator profile will be automatically chosen when publishing a submission from docuBridge. 

This entry was posted in Regulatory Affairs News.

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