MHRA encourages e-cigarette manufacturers to obtain UK marketing authorisations

The MHRA has issued guidance encouraging electronic cigarettes and other inhaled nicotine-containing products to be licensed as medicines and medical devices (in the case of refillable e-cigarettes) in the UK.

Aside from the fact this would allow e-cigarettes to be supplied on the NHS, e-cigarettes that are regulated as medicines may be available in strengths greater than those currently permitted under the Tobacco Products Regulations, thereby allowing diversification of product portfolios.

The MHRA’s guidance encourages manufacturers to submit a marketing authorisation (“MA”) application under the “generic” or “hybrid” route – i.e. an abridged MA application procedure which avoids the need for carrying out clinical trials and generating non-clinical data by relying on an already authorised reference product. Interestingly, and somewhat unusually, the MHRA even goes so far as to identify a potential reference product.

Marketing authorisation: medicinal product

“Full” MA applications, which include all non-clinical and clinical data necessary to establish safety and efficacy, benefit from data and market exclusivity rights. Once those exclusivities have expired, manufacturers are able to submit “generic” and “hybrid” MA applications relying on the data submitted in support of the “full” MA.

Manufacturers should be aware that the “generic” route is only viable if they can establish (i) bioequivalence; and (ii) their e-cig has the same qualitative and quantitative composition in active substance (i.e. nicotine) and the same pharmaceutical form as the reference product. The “hybrid” route is available if bioequivalence cannot be demonstrated or there is a change in active substance, therapeutic indications, strength, pharmaceutical form, or route of administration compared with the reference product. In such a scenario manufactures are able to submit “bridging data” to support the MA application.

Post-authorisation, MA holders in the UK need to ensure they can fulfil pharmacovigilance requirements (including the collection, monitoring, assessment and evaluation of information related to adverse events), and comply with regulations addressing good manufacturing and distribution practice (which will likely require additional licences).

Medical devices

Medical Devices also need to be registered with the MHRA and require a CE mark (or from 2023 a UK Conformity Assessed mark (UKCA)) in order to be placed on the market. Medical devices are accorded a classification depending upon their risk profile and how a medical device is classified will depend on factors including the intended purpose of the device.

The MHRA’s view is that the part of the e-cigarette containing the battery together with any associated charging accessories would be a Class IIa active therapeutic medical device, unless the administration is in a potentially hazardous manner in which case they would be Class IIb. In order to obtain a CE mark (or UKCA) a Notified Body/UK Approved Body will carry out a conformity assessment to examine the safety and performance of the device.

Once on the market, medical device manufacturers also have post-market surveillance and vigilance obligations.

Conclusion

The MHRA has a scientific advice procedure which allows for an open discussion with the regulator prior to submission of an application for an MA. Appropriately formulated questions should allow e-cigarette manufacturers to obtain a good degree of comfort prior to making their MA application.

The MHRA has issued a clear statement of intent to work with e-cigarette manufacturers in order to assess safety and efficacy. We therefore expect the scientific advice procedure to be of particular utility, at least initially, in helping e-cigarette manufacturers develop an authorised medicinal product.

Although the MHRA is responsible for overseeing both e-cigarettes as medicines/medical devices and consumer products, the e-cigarette consumer products market is significantly less regulated. There are currently only two e-cigarettes that have been granted MAs by MHRA. It remains to be seen whether existing e-cigarette manufactures will be willing to navigate the medicines and medical devices regulatory hurdles required to place a product on the market as a medicine.

If you would like to discuss the regulatory requirements outlined in this article in more depth, please contact Caitlin Heard [email protected]