Human studies play an important role in providing evidence to the regulator that an NGP is likely to be of benefit to current smokers. Across E-vapor, heated tobacco and modern oral products, the data from human studies are pivotal in regulators gaining confidence in the likely health impact of your NGPs.
Human studies are a pivotal component in the submission of a PMTA/MRTP to the US Food and Drug Administration and to the European regulatory agencies for an MAA. Broughton Nicotine Services provide an end-to-end support service with specialists at the forefront of the NGPs field as well as an extensive network of experienced clinical trials facilities to ensure the study design, conduct and data interpretation are aligned with the expectation of global regulators.
The key areas that we focus on are:
Several different types of human studies are required to demonstrate that the marketing of an NGP is likely to promote the wellbeing of current smokers. The overall aim of these studies is to demonstrate that an NGP poses less safety or health risks to users compared to smoking combustible cigarettes, and that a particular product's appeal is towards its target user and not towards unintended users.
Broughton Nicotine Services provide a turn-key service in the design, conduct and reporting of human studies in four core areas:
Broughton Nicotine services integrates all the information gathered by these studies to generate a narrative in a PMTA submission, which demonstrates whether the marketing of an NGP is Appropriate for the Protection of Public Health (APPH).
Broughton Nicotine Services offer a wide range of services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the NGPs sector. This full-service, when integrated with our other NGP-focused scientific services, supports regulatory submissions and enables new product development to advance a smoke-free future.
Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.
Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.