eSubmitter Overview and Checklist

The creation of a premarket tobacco product application (PMTA) involves thousands of hours of work across several disciplines, generating documents across many scientific work streams. All of the data generated must then be compiled and packaged electronically for submission to FDA CTP using a software called eSubmitter. The FDA eSubmitter is a free software that supports the creation of electronic submissions of most of the submissions accepted at FDA CTP. This application contains no modules or technical standards for how the data must be ordered, like the eCTD module used by other Centers for example. There are also currently no application standards (eTTD is still in some sort of proposal state) or data standards (TIG v1.0 is in development) for tobacco product submissions. This can be problematic when building regulatory submissions with a large amount of disparate data (HPHC data, CMC data, toxicological data, clinical trial data). FDA does provide a user guide for reference.

This post will provide a quick overview of tactical submission strategies to consider when building applications and submitting files electronically to FDA Center for Tobacco Products (CTP) using eSubmitter.

CTP eSubmitter submission creation page

Imagine logging onto a computer in 1995. That exact experience can be recreated when using the eSubmitter software today. eSubmitter is a JAVA-based application and is downloaded locally onto a user's computer where applications are built locally before being transmitted via the CTP Portal. It is recommended to download the application on a Windows machine as there is an incompatibility with Macs. If you have a Mac, I would recommend downloading software that creates a virtual PC like Parallels.

It is sometimes seen as an afterthought to compile, qc and publish a submission when the focus should be on the science, but because of the limitations of eSubmitter it helps to be strategic in how a submission is organized and submitted upstream via the content plan development as well as data outputs.

Here are a few checklist items to consider when building a submission in eSubmitter:

• No need to register eSubmitter when initially opened. Always click 'Register Later'.

• Organize the submission in no more than 3-levels of hierarchy. This is partly due to the file path limitations of 200-characters. The deeper the hierarchy, the longer the file path. Plus, the further nested a file is the more potentially confusing it is for a CTP reviewer to find.

• Create modules similar to eTTD and name all files with a leading 01, 02, 03 etc. so the files can quickly be ordered within the submission folder. All files will ultimately be attached to the eSubmitter transmittal form in a flat file structure (ie one folder).

• Make sure all files are in the correct format as specified by CTP in the user guide (.pdf but never .docx) and that they are compressed to limit file size.

• Before packaging the submission (ie zip the files) be sure to run an Output -> Missing Data Report as well as an Output -> Submission Report as a final submission qc. These reports should indicate if any files were missed in the file attachment process. 400 files in the folder pre-attachment should equal 400 files on the transmittal form.

• Create a .pfx certificate in order to encrypt and digitally sign the packaged submission.

• Give sufficient time to transmit the .zip file(s) via the CTP Portal. It could take 10 minutes or it could take 10 hours depending on portal traffic.

• That's the 10,000 ft view of eSubmitter. Check out my newsletter for more content like this.