FDA Plans to Improve Portal for New Tobacco Product Applications
WASHINGTON, D.C. — According to new notices filed in the Federal Register, the U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) intends to launch a next-generation CTP Portal next year.
[Read more: Tackling Tobacco: June 2024 Legislative & Regulatory Roundup]
The improved web portal should help ease the submission process for applications of certain new tobacco products with updated features, including:
- Streamlining 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.
- A more efficient submission process by eliminating the need for multiple tools, including combining PDF-editing software, the FDA's eSubmitter Desktop Tool and the FDA's CTP Portal web application in one place.
- Tools to expedite data entry, guide applicants to relevant sections and verify that all required data have been provided by the applicant.
The FDA stated current users of the CTP systems do not need to take any action regarding the planned improvements. Existing accounts, along with any pending or in-process applications, will be automatically migrated to the new portal.
However, 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 are seeking comments from the public on the input of that information from now through Sept. 14 at 11:59 p.m. ET. Drafts of the updated forms and screenshots of the new system can be viewed in the docket for these notices.
The CTP plans to provide additional communication and support leading up to the change in the coming months, including resources on how to use the new system.
The update is part other work by the FDA to help tobacco manufacturers and retailers keep track of current approvals and regulations. In March, the agency launched its new Searchable Tobacco Products Database, a user-friendly, online list of tobacco products designed to provide key information for the public in a single location.