In October 2023, the FDA's Center for Tobacco Products (CTP) released the sixth edition of the "Electronic Submission File Formats And Specifications" document, which clarified the relevant requirements for electronic submissions. Detailed explanations, especially demonstrations of Heading of Contents and Hierarchic.

For example, an electronic document should contain 7 templates:

1) Module 1: Administrative information (Module 1: Administrative)

2) Module 2: Summary (Module 2: Summary)

3) Module 3: Product Description and Manufacturing

4) Module 4: Nonclinical

5) Module 5: Clinical - Product Impact on Individual Health (Module 5: Clinical - Product Impact on Individual Health)

6) Module 6: Clinical – Product Impact on Population Health Module 6: Clinical – Product Impact on Population Health)

7) Module 7: Environmental Impact (Module 7: Environmental Impact)

Tools for electronic submission: eSubmitter Software

Data submission platform: CTP Portal



The PMTA review process can be roughly divided into 6 processes, as follows:

PMTA review process

Submission Tracking Number (STN) refers to the code assigned by the system after FDA receives the applicant's information, such as PMTA or supplementary PMTA, and conducts preliminary review by the system. Primarily used to identify any previously submitted information about tobacco products that matches the applicant. This process occurs around Phase 0 (i.e. before or after the meeting). Getting an STN is just the beginning of a PMTA.