As we prepare ENHALE for clinical study; a nicotine inhaler and the first of our products, we have had to carefully consider the regulatory implications of NRT (nicotine replacement therapy) as NRT is subject to some stringent regulations in order to be considered NRT rather than an e-cigarette or similar products.
What are the regulatory implications of NRT?
It is important to note that e-cigarettes are not considered to be NRT. They are not officially recommended by the NHS or doctors to quit smoking, whereas NRT such as nicotine inhalers, gum and patches are.
NRT and other products promoted with the goal of aiding consumers to quit smoking are classified as medicinal products and can only be placed on the UK market when they are granted authorisation from the licensing authority or European Commission, in accordance with The Human Medicines Regulations 2012 (S.I. 2012/1916).
How are we addressing these with ENHALE?
In order to obtain marketing authorisation for ENHALE, we are currently conducting extensive testing to ensure that it is safe to use and meets the requirements set out by The Human Medicines Regulations 2012 (S.I. 2012/1916), including:
- Product and design development: ENHALE has been carefully conceptualised and designed to help consumers quit smoking, so when developing the design of the product, we made sure that it is able to solve the problem it was intended to, and is user-friendly, both important elements if the ENHALE is to improve a smoker’s chance of quitting.
- CE marking: ENHALE has been CE marked as a medical device, showing that the device conforms with regulations and is fit for its intended purpose. We are committed to making this innovative product a safer option for consuming nicotine.
- Drug safety and stability: in order to ensure the safety of ENHALE, we carry out safety and product stability tests to confirm the product’s shelf life and determine the effect of environmental conditions on product quality over time.
- Clinical studies: Ventus has conducted various clinical trials in order to determine things such as device efficiency, ease of use, taste and risk of use.
- Submission and approval from the European Union to market ENHALE as a medical device
In summary, there are many regulatory implications of developing an NRT, and here at Ventus Medical we are working to ensure that ENHALE meets all regulatory requirements so we can help people to stop smoking safely.