Broughton's Chief Scientific and Regulatory Officer Dr. Nveed Chaudhary discusses the recent FDA announcement on marketing orders and what this means for ENDS manufacturers.
The race to register e-cigarettes as medicinal products in the UK
Nov 30, 2021 | Published by Chris Allen
Broughton's Chief Scientific Officer, Chris Allen shares his opinion with Financial Times about e-cigarettes on the NHS.
Broughton’s Chris Allen has offered his expertise to the Financial Times in an article about the race to register e-cigarettes as medicinal products in the UK.
E-cigarettes have been firmly in the public eye since the announcement that the National Health Service (NHS) could look to prescribe them to smokers in the future.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued detailed guidance for manufacturers wishing to pursue the medicinal route as the UK aims to be smoke-free by 2030.
The Financial Times article discusses moves by smaller manufacturers to begin their medicinal licence applications ahead of the Big Tobacco companies. The piece names manufacturers that have already begun their applications, stating that none of the larger listed tobacco companies have started along the route yet.
Chris, Chief Scientific Officer, has spoken out previously to welcome the updated MHRA guidance, which he believes will provide advantages, including improving the perception of ENDS products in the eyes of the public and practitioners.
He told the FT reporter he believed the costs associated with the Marketing Authorisation Application (MAA) could amount to as much as £3m to £5m for a single product, resulting in only a handful of companies going down the route.
You can read the full article here.
To find out more contact us to arrange a meeting.
Can we help you?
Broughton have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; creating a smoke-free future.
Book a meeting with us today to discuss your requirements.