In December 2014, the US FDA published a binding guidance document, Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Standardized Study Data, that establishes a requirement for submitting study data (clinical and non-clinical) in electronic format conforming to CDISC standards. After the publication of this guidance, all studies with a start date 24 months after the publication date (December 2014) must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog for NDA, ANDA, and certain BLA submissions. Study data contained in certain IND submissions must use the specified formats for electronic submission in studies with a start date 36 months after the publication of this guidance.
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.
The requirement to submit certain drug applications in electronic format is at least three years off, and the target date for the implementation of the new Module 1 has been extended yet again according to representatives of the U.S. Food & Drug Administration.