No new e-cigarette license applications since UK medicines regulator changed guidelines

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The drugs regulator has not received any applications from companies to authorize e-cigarettes as drugs to help quit smoking, since regulatory guidelines were updated six months ago, The Pharmaceutical Journal has learned.

In October 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) published updated guidance for the licensing of e-cigarettes and other products containing inhaled nicotine as medicines to help stop smoking.

At the time, the Department of Health and Social Care said the update‘paves the way’ for medically licensed e-cigarette products to be prescribed by the NHS, in what would be a ‘world first’.

The MHRA said the orientationwhich was first published in December 2017, focused on “Quality Standards for Dose Uniformity, Nonclinical Toxicology Data Requirements and Design of Clinical Pharmacokinetic Studies”.

However, in a statement made to The Pharmaceutical Journal on April 5, 2022, the MHRA said it had yet to receive any license applications from manufacturers since the update.

“Since we published our updated guidance for licensing e-cigarettes and other products containing inhaled nicotine as smoking cessation aids, companies seeking regulatory approval have received significant of interest.

“While no new industry license applications have yet been submitted, we are providing ongoing guidance to companies and are prepared to quickly assess any application we receive,” he said.

“The MHRA recognizes that some companies producing or developing e-cigarettes may not be familiar with the evidence requirements of the medicines and medical devices regulations,” the statement continued, adding that the MHRA encourages such companies “to contact us for get regulatory and scientific advice as soon as possible.” as possible “.

Robert West, Professor of Health Psychology and Director of Tobacco Studies at University College London, said: “As expected, the regulatory process still presents an insurmountable hurdle for most e-cigarette manufacturers.

“The cost of building a case is beyond their means, and the idea of ​​cost sharing among manufacturers, while laudable, has always seemed unrealistic in a competitive market.

“Another deterrent is that the market for prescription e-cigarettes is likely to be small compared to the over-the-counter market.

“A major concern when the new regulatory process was announced was that it would be the tobacco industry, with its deep pockets, who would benefit, and that remains the case.”

Deborah Arnott, chief executive of public health charity Action on Smoking and Health, said: ‘Applying for a medical license requires putting together a very detailed dossier which can take much longer than six months.

“The fact that no applications have yet been filed is no reflection on the consumer e-cigarettes currently on the market, which already meet the safety standards set and overseen by the MHRA.

“Around 3.6million people use e-cigarettes in Britain, so if there were any serious safety concerns about e-cigarettes currently on the market, we would have expected the card monitoring system MHRA yellows have detected them by now.”

In June 2021, draft guidance produced by the National Institute for Health and Care Excellence and Public Health England said healthcare professionals, including pharmacists, should offer advice on e-cigarettes as a smoking cessation strategy.

The guidelines cite evidence that e-cigarettes containing nicotine are just as effective as other smoking cessation options, such as nicotine replacement therapy.

However, research on the use of electronic cigarettes has not always been positive. One study, which followed 32,000 adults over three years, found that e-cigarettes significantly increased the risk of chronic lung disease, while another found that people who use e-cigarettes at the same time as traditional cigarettes are no more likely to quit smoking in the long term than those who only smoke cigarettes.

In 2019, the European Respiratory Society declined to recommend the use of e-cigarettes as a smoking cessation aid, after saying it amounted to “replacing a very harmful product with a less harmful, but still harmful product”.

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