On July 15th, the Center for Tobacco Products (CTP) of the US Food and Drug Administration (FDA) published two notices in the Federal Register, stating their plans to launch a new generation CTP web portal next year for the submission of certain new tobacco product applications.
The purpose of this improvement is:
Integration of major Substantial Equivalence (SE) reports and Premarket Tobacco Product Applications (PMTAs), previously submitted amendments, and general correspondence into one system; introducing a more efficient submission process by eliminating the need for multiple tools (including consolidating PDF editing software, FDA's eSubmitter desktop tool, and FDA's CTP Portal web application into one place); providing tools to expedite data entry, guide applicants to relevant sections, and verify that all necessary data has been provided. No action is required for current users of any CTP system for these improvements in the works. Existing CTP Portal accounts and any pending or ongoing applications will automatically migrate to the new CTP Portal Next Generation. CTP will provide additional communication and support before the changes take effect.
As part of submitting SE reports and PMTAs in the CTP Portal Next Generation, applicants will need to enter certain information on the applicable forms. Therefore, two Federal Register notices (one regarding SE, one regarding PMTA) announced today are seeking public input on entering this information.
The public comment period will begin on July 16 and end on September 14 at 11:59 PM (Eastern Time).
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