Toxicological overview for a medicinal nicotine replacement device (MHRA submission)


An e-cigarette manufacturer intends to market a novel electronic nicotine delivery system (ENDS) device as a therapeutic nicotine replacement therapy in the UK. As such, the MHRA must approve the use of this device as a medicinal product. With the support of a regulatory affairs consultancy, bibra was asked to construct a non-clinical overview of the ENDS device for a marketing authorisation application.


An American manufacturer of e-cigarettes and other vaping products.

Project goals

Such a marketing authorisation should contain a toxicological overview of the excipients, flavourings and additives of the device, which includes a multi-constituent e-liquid. In addition, the toxicity, pharmacology and pharmacokinetics of the active ingredient (nicotine) need to be addressed as part of the non-clinical overview. In addition, any potential health risks associated with the inhalation of potential leachables and anticipated emissions from the device, and its biocompatibility require evaluation.


The client provided compositional details for the e-liquid formulation, including all excipients and their concentrations, compilations of toxicity data for each constituent (which included (Q)SAR analyses to fill any data gaps. The consumer daily exposures were estimated and a risk assessment of the main components was conducted. Bibra was provided with analytical data regarding the potential leachables of the device, as well as various biological test study reports (including cytotoxicity, intracutaneous reactivity, pyrogenicity and acute systemic toxicity), conducted with extracts of the product, to provide insights into the biocompatibility of the device.

Project outcome

Bibra provided the client with non-clinical overview technical summaries relating to toxicology, pharmacology and pharmacokinetics, which were then incorporated into the marketing authorisation application submitted to the MHRA.

Bibra project team

Charles Johnson
Richard Young
Pete Watts


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