The U.S. Food and Drug Administration (FDA) has introduced web versions of four forms in its CTP Portal Next Generation (CTP Portal NextGen), streamlining the submission and amendment process for premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. The transition from the previous CTP Portal to the NextGen platform was completed in early 2025.

The new web forms (FDA 4057, 4057a, 3965, and 3965a) allow applicants to create, validate, and submit PMTA and SE Report applications directly through the portal. Key features include step-by-step guidance, a user-friendly interface, real-time automatic validation, the ability for multiple users to collaborate on submissions, and easy draft saving. These improvements aim to make the application process more integrated, efficient, and transparent.

PDF versions of the PMTA and SE Report forms remain available for applicants who prefer them. Updated PDF forms were also published online, and starting January 2, 2026, applicants must use the latest versions for submissions. Failure to use the current forms may result in refusal to accept the application.

While the new web forms currently cover PMTAs and SE Reports, FDA plans to expand this functionality to other submission types, such as Exemption Requests, Harmful and Potentially Harmful Constituents reports, and Tobacco Product Ingredient Listings, in future phases.