Premarket Tobacco Application (PMTA)

GlobalSubmit facilitated the first ever FDA authorization of a premarket tobacco application (PMTA). The application filed by Swedish Match North America was submitted to FDA under the PMTA pathway on March 11, 2015. FDA issued a marketing order on November 10, 2015.

To date, the FDA has yet to authorize marketing of any other new tobacco products through the PMTA pathway.

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GlobalSubmit has the unique advantage of integrating best practices based on previous success with PMTAs as well as gathering new information through a direct feedback mechanism set up with FDA.

Immediate Impact for Tobacco Industry (90 Days)

Here are the requirements manufacturers of newly deemed products must fulfill by August 8, 2016.

  • Remove unsubstantiated (adulterated or misbranded) claims from products or face FDA enforcement
  • Submit ingredient listings and report on Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke – 904(a)(3) Reports
  • Register tobacco product manufacturing establishments and product listings
  • Cease sale and distribution of products with modified risk descriptors and claims unless FDA issues and order authorizing their marketing
    • If manufacturer believes there is a basis to a modified risk claim, this provision would lead to the submission of an MRTP
  • Cease distribution of free samples
  • Premarket review requirements – See Staggered Compliance Periods

Staggered Compliance Periods

The FDA has set staggered compliance periods based on premarket review pathways that will effect new products deemed subject to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act.

“FDA is establishing staggered initial compliance periods based on the expected complexity of the applications to be submitted, followed by continued compliance periods for FDA review”

Here are the timelines for available premarket review pathways:

Premarket Tobacco Application Pathways

PMTA Submission Services

GlobalSubmit has extensive experience in preparing all aspects of regulatory submissions to the US FDA. The services described below are available and potentially within the project scope of preparing a premarket tobacco application (PMTA).

Project Scope and Content Planning

Original applications are typically complex in nature and have total project durations 12-18 months. At times projects may run shorter or longer depending on details specific to the scope of information to be submitted and how far along content development is at the time GlobalSubmit is engaged in services.

Our regulatory services team collects project scope information in order to determine the size and effort needed to generate the submission by a sponsor’s target date. Based on the scope, delivery milestones are established to allow for work to be processed incrementally as documents are finalized. At times, there are delays in delivering individual components and milestones are missed due to circumstances outside of the project team’s control. Expedited and rush processing services are available to accommodate meeting deadlines in a condensed period of time.

Document Authoring

GlobalSubmit has a network of experienced medical and technical writers we contract on an individual project basis as required. Our network includes writers who have direct experience preparing PMTAs.

Document Formatting

Includes formatting documents in native Microsoft Office applications, as well as rendering these documents to PDF and then publishing them according to well-established electronic submissions standards dictated by the US FDA.

To aid in the process of generating “submission ready” documents, GlobalSubmit offers authoring templates and a document style guide. We are also able to offer standards documents, such as an Authoring Style Guide and training resources to provide the authoring team a consistent set of standards for authoring documents should the applicant elect to format documents internally with a cross-functional team of SMEs.

Regulatory Strategy and Operational Consulting

Regulatory strategy and operational consulting are key elements to ensure the successful outcome of interactions with the US FDA. Regulatory strategy consulting includes both interactions with US FDA seeking alignment in approach for PMTA applications as well as interpretation of US FDA guidance documents and regulations to ensure project approach is both comprehensively and adequately aligned with what is needed in order to obtain a successful US FDA review outcome.

Regulatory operational consulting provides guidance and practices around assembly and logistics of the filing, i.e., determining a logical structure for organizing content and verifying that electronic navigation is both adequate and accurate.

GlobalSubmit has also served in an advisory capacity on behalf of our PMTA clients in multiple meetings with FDA, including:

  • Pre-submission meetings focused on content and preparation efforts for PMTA and seeking consensus in approach
  • Post-submission meetings to provide responses to reviewer questions that arise during the course of review
  • Consultative services to prepare materials in advance of meetings with FDA involving only sponsor and Agency

Publication of PMTA Submission Documents

The organization and publishing of submission documents including defining a set folder structure, file names and utilization of hyperlinked indices to aid in navigation. Files are published in accordance with documented, well-established and accepted standards for electronic submissions to the FDA.

PMTA Submission Leadership

Regulatory service projects are structured to include a Submission Lead, Submission Coordinator, and Publishing Lead. This team structure provides continuity and a clear point of contact throughout the engagement. Your submission team leader is responsible for deliverables and oversight throughout the course of a PMTA submission project including:

  • Project management of the PMTA project
  • Regular communication and project status
  • Resource allocation and management for all publishers involved
  • Build and update the PMTA Submission Tracker that will identify each component and track status at a file level
  • Build and update the issues log to track issues through to resolution at the file level
  • Track overall project risks and issues and then communicate those risks and issues in monthly status reports
  • Review all submission components for PMTA readiness
  • Deficiency reporting on PMTA related issues
  • Act as technical contact to FDA for submission related inquiries
  • Obtain application number from FDA (if necessary)

Conversion of Data Sets

Generate define files according to Clinical Data Interchange Standards Consortium (CDISC) data standards for non-clinical and adult human studies.

Submission Transmission via FDA Electronic Submissions Gateway (ESG)

Transmission of PMTA submission using applicant or GlobalSubmit ESG account. If ESG is unavailable or applicant elects alternate mode of transmission files can be submitted electronically on physical media (CD or DVD).

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Premarket Tobacco Application (PMTA) – Related Guidance Document(s)

FDA Presentations