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The U.S. Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) has announced plans to launch CTP Portal Next Generation in 2025, an improved web portal for submitting applications for certain new tobacco products. This enhancement aims to streamline the electronic submission process, combining tools into a single system for efficiency.
Improvements include:
A single platform for submitting substantial equivalence (SE) reports, premarket tobacco product applications (PMTAs), amendments, and general correspondence.
Elimination of the need for multiple tools, integrating PDF-editing software, FDA’s eSubmitter Desktop Tool, and the CTP Portal Web application into one place.
Features to expedite data entry, guide applicants to relevant sections, and ensure all required data is provided.
Existing users of CTP systems do not need to take any action, as current accounts and pending applications will be automatically migrated to the new system. CTP is committed to ensuring a smooth transition by providing additional communication and support, including resources on using the new portal.
As part of the transition, the FDA has issued two notices in the Federal Register seeking public comments on the input of required information for SE reports and PMTAs in the new portal. The public comment period is open from July 16 until September 14 at 11:59 pm EST. Drafts of the updated forms and screenshots of the new system can be viewed in the docket for these notices. It is important to stay informed and prepare for these changes to ensure compliance and take advantage of the improved submission process.
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