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CTP Portal NEXTGEN Preview
Author.
LCS
Source:
Post time:
2024-12-06
background
On June 22, 2009, then US President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act (TCA), authorizing the US Food and Drug Administration (FDA)/Center for Tobacco Products (CTP) to regulate the production, marketing, and distribution of tobacco products, marketing, and distribution of tobacco products）。
objective
CTP Portal is a platform developed by CTP for the tobacco related industry to submit information, and is a measure taken by the FDA to improve submission processing and promote interaction with the industry. CTP uses the CTP portal to regulate the tobacco industry by analyzing the information submitted to CTP by manufacturers, importers, and distributors.
However, the CTP portal currently faces many challenges, especially considering the possibility of hindering the processing and access to industry submitted content. In order to improve transparency and facilitate communication to accelerate problem-solving, CTP is expected to be updated to the next generation CTP portal (Center for Tobacco Products Portal Next Generation) in early 2025 as part of simplifying the application process for industry stakeholders.
New news
In the middle of this month, CTP launched an internal testing invitation for the next generation tobacco product center portal website CTP Portal NG, officially known as the Pilot Testing program. The CTP portal will not replace the existing FDA system and corresponding requirements, including but not limited to tobacco registration and product list submission through the FDA Unified Registration Listing Systems (FURLS).
CTP Portal NG provides a more integrated, efficient, and secure solution for managing file submissions.
The new platform introduces dynamic web forms for Premarket Tobacco Product Applications (PMTA) and Substantial Equivalence (SE) submissions. For other submission types, the FDA's eSubstanter desktop tool will continue to be used for submitting package uploads, but has enhanced integration with CTP Portal NG for easier access and processing.
Account registration and login
CTP Portal NG provides single sign on (SSO), allowing users to access all relevant organizations with one account. Considering that CTP Portal NG is currently an invitation based system and has not yet been fully tested or officially launched, this article will skip the introduction of CTP registration and only briefly explain the new features involved in CTP Portal NG.
Login interface
Note: CTP Portal NG introduces a two factor authentication mechanism for account security, called OTP (One Time Password), which means that an email will be sent to the login email before each login, and only by entering the email verification code can one log in.
The main functions and advantages of CTP PORTAL NEXTGEN
Homepage interface after login
Dynamic Web Forms: Applicants can directly create (see Figure 1), validate (see Figure 2), and submit PMTA and SE submission packages through the portal, simplifying the process by eliminating the need for multiple software tools (such as some application processes no longer relying entirely on eSubmitter).
After creating a submission package, the system will assign a Package ID (such as PKG01234567) to this item and open the PMTA network form.
Upload of submission packages for other submission types: Although PMTA and SE submissions will use web forms, other submission types will continue to be processed through eSubmitter. These submission packages will also be processed in the new portal to ensure a simplified and consistent submission experience for all formats.
Simplify data input and integrate validation: Forms are dynamically adjusted based on user input, and real-time validation helps minimize errors to the greatest extent possible.
If the required associated information is not completed in the previous step, the system will determine that the information is missing and remind the operator to fill in the previous information first.
• Improve efficiency and usability: The new portal provides step-by-step instructions, context sensitive tooltips, and a user-friendly interface to guide users through the submission process.
The new portal provides distribution instructions and is accompanied by a large number of text explanations and tooltips at each step, making the interface more user-friendly and making the operation smoother.
Unified account access and improved security: A single account will grant access to one or more organizations (if applicable), and multi factor authentication (MFA) will add additional security.
After all submissions are completed, the system will send a message that the submission package has been received, and then wait for FDA/CTP review.
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