U.S. FDA To Launch Next-generation CTP Portal in 2025 To Simplify New Tobacco Product Application Process
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U.S. FDA to launch next-generation CTP portal in 2025 to simplify new tobacco product application process
The FDA's Center for Tobacco Products (CTP) announced that it will launch a new generation of the CTP portal next year to streamline the application process for new tobacco products and is seeking public input on related improvements. The public comment period begins on July 16 and ends on September 14.
On July 15, the FDA's Center for Tobacco Products (CTP) published two notices in the Federal Register stating that it plans to launch a new generation of the CTP portal next year for submitting applications for certain new tobacco products.
The purpose of this improvement is to:
Integrate the electronic submission of significant equivalence (SE) reports and premarket tobacco product applications (PMTAs), previously submitted amendments, and general communications into one system;
Introduce a more efficient submission process by eliminating the need for multiple tools (including merging PDF editing software, FDA's eSubmitter desktop tool, and FDA's CTP Portal web application into one place);
Provide tools to speed up data entry, guide applicants to relevant sections, and verify that applicants have provided all required data.
For users of any current CTP system, these planned improvements do not require any action. Existing CTP Portal accounts and any pending or in-progress applications will automatically migrate to the new CTP Portal Next Generation. CTP will provide additional communication and support in advance of the change.
As part of submitting SE reports and PMTAs in CTP Portal Next Generation, applicants will need to enter certain information on the applicable forms. Therefore, two Federal Register notices announced today (one for SE and one for PMTA) are seeking public comment on entering this information.
The public comment period begins on July 16 and ends at 11:59 p.m. (EST) on September 14.
