FDA to enforce the Technical Rejection Criteria (TRC) beginning Sept 15th, 2021
( Technical Rejection Criteria for Study Data)
The TRC has been added to the existing eCTD validation criteria to enforce compliance with the SEND requirements for study types modelled in an FDA supported SEND Implementation Guide (SENDIG) version. Any electronic submission submitted after Sept 15th, 2021 will be rejected if the submitted datasets don’t pass the same. Our PointCross Validation engine have already been extended to ensure that all datasets are checked against the Technical Rejection Criteria. You can verify your datasets and make sure that they do pass the TRC by using our eDataValidator.
Study data standards are required in clinical and nonclinical studies that start after December 17, 2016. Technical rejection criteria have been added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines below and will become effective on September 15, 2021.
FDA will not accept an electronic submission that does not have study data in compliance with the required standards specified in the FDA Data Standards Catalog. The standards apply to the following types of submissions to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER):
• New drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
• Commercial investigational new drug applications (INDs) (for products that are intended to be distributed commercially).
Learn more about: FDA Study Data Technical Rejection Criteria (TRC)