Modified Risk Tobacco Product (MRTP)

The US FDA’s Center for Tobacco Products (CTP) is accepting Modified Risk Tobacco Product (MRTP) applications.

GlobalSubmit was an integral part of the first ever successful MRTP application. That submission was officially accepted for review by the FDA in July 2014. Information related to the submission is publicly available on the FDA MRTP website.

During the April 9-10, 2015, Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss MRTP applications submitted by Swedish Match, GlobalSubmit was the only non-FDA, non-tobacco organization to address the audience.

 

Request a Copy of the Swedish Match MRTP Case Study

Swedish Match Modified Risk Tobacco Product (MRTP) Case Study

 

MRTP Submission Services

  • Project Scope/Content Planning
  • Regulatory Writing
  • Document Formatting
  • Regulatory Strategy and Operational Consulting
  • Publication of Submission Documents
  • Submission Leadership
  • Conversion of Data Sets
  • Submission Transmission via FDA Electronic Submission Gateway (ESG)

GlobalSubmit has the unique advantage of integrating best practices based on previous success with MRTP applications as well as gathering new information during regular communication with the FDA related to active applications. Keep in mind that draft Guidance for Industry: Modified Risk Tobacco Product Applications, published in March 2012, represents the most current thinking publicly available on this particular topic and merely contains suggestions/recommendations. Strict requirements are yet to be enshrined.

The Agency is treating each subsequent MRTP submission as an opportunity to implement more efficient and effective submission procedures. Focused on quality and compliance, our experienced team has an in-depth understanding of what FDA reviewers expect in order to properly review marketing applications – in this case for a Modified Risk Tobacco Product.

As a result of our experience with pharmaceutical and biotechnology submission projects, in addition to accepted and ongoing MRTPs, GlobalSubmit has experienced virtually every scenario possible during these complex regulatory processes. In the event complications arise, our network of contacts will yield a resolution. Such familiarity translates into assuredness at a mission-critical moment.

Our team is available to provide an initial consultation or answer questions related to MRTP submissions to the US FDA.

Email sales@globalsubmit.com for more information.

Modified Risk Tobacco Product (MRTP) – Related Guidance Documents

Modified Risk Tobacco Product (MRTP) – Helpful Links