The U.S. Food and Drug Administration's (FDA), Center for Tobacco Products (CTP) developed the CTP Portal as part of its initiative to improve submission processing and to foster interaction with Industry. The CTP Portal allows Industry to use the embedded upload feature to transmit eSubmitter- generated submissions; this new transmission method offers Industry an alternative to the Agency's existing WebTrader Hosted Solution. The eSubmission File Formats and Specifications document is available to provide an overview of the technical file formats and data specifications related to submitting electronic files to CTP.
The CTP Portal is intended for use by regulated tobacco Industry, including manufacturers, importers, and distributors who make submissions to CTP. The CTP Portal should improve transparency and facilitate communication to speed issue resolution that may otherwise hinder processing and/or access to industry submissions.
The CTP Portal does not replace existing FDA systems and corresponding requirements, including but not limited to Tobacco Registration and Product Listing submissions made via the FDA Unified Registration Listing Systems (FURLS).
Each regulated tobacco organization should have one or more Industry Account Managers (IAMs) who assume responsibility for managing users of the CTP Portal for their respective organization. These Industry Account Managers are able to add new users, grant corresponding user roles and permissions, lock and unlock user accounts, and edit information for existing user accounts.
If your organization has an IAM: If other members in your organization currently have user accounts, we encourage you to reach out to your organization's Industry Account Manager and request that they create a new user account on your behalf. They will be able to designate the appropriate user role for your account, including designating you as an Industry Account Manager, if appropriate.
If your organization does not have an IAM: If you are not aware of any members of your organization currently having CTP Portal user accounts, please request an Industry Account Manager (IAM) account. CTP staff will review your request and communicate CTP Portal User account updates as they become available.
For optimal performance, we recommend using Internet Explorer (IE) 11, or the latest versions of Mozilla Firefox or Google Chrome.
If using Internet Explorer (IE) 10, or earlier versions of Firefox and Chrome, you may experience minor visual deviations and limitations. Please note older browsers such as Safari 5 and below, IE 9 and below, as well as Linux/Unix specific browsers (e.g., Konqueror, Camino) are not supported.
Before using FDA Industry Systems (FIS), FDA strongly encourages all users to have current antivirus and antispyware software installed on your computer to help ensure the privacy of information being entered.