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FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025

Beginning 7/16, public may provide comments until 9/16

July 15, 2024

Today, FDA’s Center for Tobacco Products (CTP) issued two notices in the Federal Register regarding its intention to launch CTP Portal Next Generation – an improved web portal for the submission of applications for certain new tobacco products – next year. 
The improvements are intended to:

  • Streamline electronic submission into one system for substantial equivalence (SE) reports and premarket tobacco product applications (PMTAs), amendments to previous submissions, and submission of general correspondence; 
  • Introduce a more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, FDA’s eSubmitter Desktop Tool, and FDA’s CTP Portal Web application in one place;  
  • Provide tools to expedite data entry, guide applicants to relevant sections, and verify that all required data have been provided by the applicant.

No action is needed from current users of any CTP systems regarding these planned improvements. Existing CTP Portal accounts, along with any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation. CTP is committed to ensuring a smooth transition to CTP Portal Next Generation and will provide additional communication and support leading up to the change, including resources on how to use the new system.  

As part of the submission process for SE reports and PMTAs in the CTP Portal Next Generation, applicants will be required to input certain information on applicable forms. Accordingly, the two Federal Register notices announced today – one for SE and one for PMTAs – are seeking comments from the public on the input of that information. Beginning July 16, the public comment period will be open through September 16 at 11:59 p.m. EST. Drafts of the updated forms and screenshots of the new system can be viewed in the docket for these notices. 

To learn more and comment on “Substantial Equivalence Reports,” visit the docket.

To learn more and comment on “Premarket Tobacco Product Applications and Recordkeeping Requirements,” visit the docket.

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