Broughton's Head of Regulatory Affairs, Lloyd Smart discusses the latest UK Medicines & Healthcare products Regulatory Agency (MHRA) guidance on licensing electronic cigarettes as medicines and important points for applicants to consider.
UK MHRA Guidance
On the 29th of October 2021, the UK MHRA issued updated guidance on how to license electronic cigarettes and other nicotine-containing products (NCPs) as medicines in the UK.
The updated guidance has tied in with an MHRA Press release entitled “E-cigarettes could be prescribed on the NHS in world first”.
Overall, the guidance has been expanded somewhat from ca 14 pages to nearly 17, and the MHRA have provided key expectations in the key areas of Quality, Safety, and Efficacy. The overriding message is still that “The MHRA seeks to encourage the licensing of electronic cigarettes (e-cigarettes) and other inhaled NCPs as medicines and aims to support companies to submit marketing authorisation applications for these products.”
Points for applicants to consider
- Guidance name has been updated to Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines and now clearly references other inhaled NCPs outside of e-cigarettes.
- References throughout have been updated to UK-specific articles/regulations for example UKCA marking now mentioned, UK Human Medicines Regulations (2012) replaces EU Directive 2001/83 for legal basis, packaging, and labelling.
- The US PMTA pathway (via FDA) is now specifically noted and the MHRA state “For applicants with products undergoing the US FDA premarket tobacco product application (PMTA) process, the MHRA can discuss what data may be relevant for a UK marketing authorisation application”. There is therefore potential to share/bridge data from other applications.
- The new 150-day (National) accelerated procedure for the assessment of high-quality applications is noted. This could potentially shorten the processing time from 210 days down to 150-days, excluding clock-stops, for the MAA.
- Updated references to test equipment and methodology for “vaping machine” where previous mentions to World Health Organisation (WHO) and British Standards Institute (BSI) Publically Available Specification (PAS) have been replaced with BS ISO 20768:2018
- Clear expectation to provide "Analytical chemistry data" should be used to confirm the compounds present in the vapour produced by an e-cigarette device under its normal operating conditions”.
- The non-clinical safety is further expanded to ensure the applicant considers repeat-dose toxicity and how read across end-points such as PK modelling, Adverse Outcome Pathways, Post-marketing surveillance can all assist in the non-clinical assessment.
- Guidance on clinical aspects (safety and efficacy) has been strengthened from ¾ page to nearly three. The underlying principle of either bioequivalences to a reference product or pharmacokinetic studies has not changed and remains in line with the legal status of the application. However, the MHRA has provided comments on how an applicant may look to design such studies i.e number of participants, sampling points and times, whether the comparison to a combustible cigarette can be excluded, how to address further nicotine concentrations and additional flavors.
The MHRA is making a clear stance as a global regulatory leader in the registration of electronic cigarettes as medicinal products.
At Broughton, our focus is to review any changes in the regulatory expectations or requirements as a result of the revised guidance recently issued. Our team has a deep understanding of the pathway for registration of electronic cigarettes in the UK and is well placed to provide full constancy in this area.
To find out more contact us to arrange a meeting.
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