Paul Hardman, Managing Consultant for Product Chemistry at vape compliance and regulatory specialist Broughton, explains the route manufacturers can take to develop NGPs as approved medical devices in the UK.
Broughton
Paul Hardman, Managing Consultant for Product Chemistry
Vaping has become increasingly popular in the United Kingdom, with approximately 1 in 8 adults saying they vape, according to a UK Government survey. However, the popularity of disposables among young people has contributed to the upcoming disposable vape ban, which is likely to take force in 2025 — irrespective of the General Election result. It is important that next-generation products (NGPs) remain available to adult smokers wishing to quit combustibles and, with regulatory pressure mounting on consumer devices, certifying NGPs as Nicotine Replacement Therapies (NRTs) via the Marketing Authorisation Application (MAA) pathway could become more important.
Vapes are recognised as a valuable smoking cessation tool as part of the UK’s Smokefree by 2030 objectives. For example, the Conservative Government committed 45 million GBP over two years to support the national “Swap to Stop” scheme, which provides a free
vape kit and behavioural support to help people quit smoking. Meanwhile, the Medicines and Healthcare Regulatory Products Agency (MHRA) is encouraging the licensing of e-cigarettes and other inhaled NGPs as medicines, and aims to support companies to submit applications for this authorisation. However, the pathway requires a large amount of scientific evidence, data, and the completion of a lengthy regulatory dossier.
This means there are limited suitable alternatives available as Ayrton Saunders’ nicotine inhaler system recently became the only MHRA approved NRT inhaler ready for commercial launch.
Consumer product or medical device?
If licensed as a medicinal product, e-cigarettes do not need to comply with the consumer Tobacco Related Products Regulations (TRPR) limits. They would be exempt from measures announced in the disposables ban, and instead subject to the requirements around the marketing and advertising of medicines. Products that receive an MAA marketing order under a General Sales license would be subject to the same sales restrictions as over the counter medicines.
Amidst a backdrop of media reports about non-compliant products, the medicinal product route will provide confidence to smokers that an e-cigarette has been developed, manufactured, and tested to strict medicinal standards.
Approaching the application
Approval via the MAA route requires a large amount of scientific data, including a pharmacokinetic study to compare the new product with an appropriate
reference medicinal product. An already approved inhaled nicotine product, such as the Nicorette 15 mg Inhalator, has been suggested by the MHRA as a suitable comparator, given the intended route of administration. The NGP will also need to be proven to be electromechanically safe — meaning it will require assessment by an approved body to receive the UK Conformity Assessment (UKCA) mark.
As medicinal products, vapes are currently categorised in the same way as pressurised metered dose inhalers (pMDIs) — meaning similar approval criteria is required.
"Vaping has become increasingly popular in the United Kingdom, with approximately 1 in 8 adults saying they vape.
However, the differences in technology — e-cigarettes are often coil and wick based and pMDIs are based on a calibrated pressurised cannister — means delivered dose uniformity (DDU) is more inconsistent with an e-cigarette.
If e-cigarettes are subjected to DDU on a per-puff basis, then most will fall short. To address this, the MHRA has set DDU requirements that are averaged over 10 puffs, rather than one, smoothing the approval pathway. However, products must still be designed to be as consistent with each puff as possible if they are to reach medicinal standards.
There are multiple ways of achieving this. Power delivery can be regulated with thermocontrols, which help ensure the same amount of vapour is being released with each inhale by setting a temperature limit that applies to the wick no matter the battery level of the device. Non-heated vape technology is another option, an alternative to traditional coil-and-wick devices that atomises rather than vaporises the e-liquid.
One example of a non-heated vape technology is those based on piezo-ceramic meshes. These work by generating ultrasonic waves to vibrate the piezo element, drawing the e-liquid through the mesh and atomising it. Piezo atomisers are already common in medical devices such as nebulisers, used to deliver asthma medication to the lungs as an aerosol. This approach may be favored since droplet size is uniformly predefined by the mesh dimensions and can be achieved with minimal energy input.
A partner throughout
The MAA process provides an opportunity for manufacturers in the electronic cigarette market to diversify and enter the medical setting. For those branching out of the consumer technology space, the scientific and regulatory data required for an MAA application can feel like a huge challenge.
Therefore, it’s beneficial for manufacturers to partner with an experienced and knowledgeable scientific and regulatory compliance expert like Broughton at the earliest possible stage. They can support from product design through to regulatory approval to help navigate the process, providing the analytical testing and regulatory expertise required to get it right first time.
