Exploring the licensed medical products pathway at ENDS US 2022

On November 9th at the ENDS US 2022 Conference, scientific and regulatory consultancy Broughton will be presenting on the regulatory approval process for Electronic Nicotine Delivery Systems (ENDS) as licensed medicinal products. At the virtual event, Broughton's Managing Consultant for Product Realization, Pete Lomas, will speak about how ENDS manufacturers can optimize products and test data collected for a PMTA submission to a UK and EU Marketing Authorisation Application (MAA). The talk will explain how the MAA pathway allows vaping devices to be classed as nicotine replacement therapies (NRTs) so they can be prescribed by doctors and other healthcare professionals in the UK and EU to help people quit smoking.

The FDA Premarket Tobacco Product Applications (PMTA) is the main pathway to marketing a consumer nicotine delivery product in the US, and manufacturers generally spend millions of dollars creating a dossier of evidence to prove their product is appropriate for the protection of public health (APPH). Those looking to market their devices in the UK and EU as an NRT could use some of this PMTA data and insight to support a subsequent MAA. Lomas' talk will explore the differences between MAA and PMTA regulatory pathways and explain that a significant amount of the data used for a PMTA could be repurposed for medicinal marketing authorization (MAA) in the UK if a device is intentionally designed for both a PMTA and UK MAA, and vice versa.

The presentation will also explore emerging technologies within the vaping industry and what these mean in relation to an MAA submission. The presentation will touch upon innovations in water-based vaping with non-heated solutions based on ultrasonics, piezo-ceramic mesh, and micro-nozzle technologies. These technologies, which atomize liquid rather than vaporize it, offer greater freedom to control particle size, are repeatable and consistent, and could reduce the risk of harmful emissions.

"In the UK, the MHRA is actively encouraging MAA submissions for ENDS as a way to help people stop smoking aligned with the government’s SmokeFree 2030 goal," explained Pete Lomas, Managing Consultant for Product Realization at Broughton. "Our regulatory experts, engineers, and scientists have extensive experience with different submission processes, and speaking at this year's ENDS US Conference is a great opportunity to share our expertise."

Broughton can support ENDS manufacturers by consulting on various regulatory pathways and supporting with product realization, analytical testing, toxicological assessments, and human studies. To find out more about how Broughton can help you prepare your nicotine product for regulatory approval, visit its website https://www.broughton-group.com/nicotine.

ENDS US 2022 will be held online from November 8-9, 2022. This industry-leading event attracts people from the regulatory, testing, and commercial sectors to come together to discuss science, compliance, standards, and regulations relating to ENDS. Attendees can register for either of the sessions here.