The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has published updated ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’.
The document provides further details on the steps needed to license an e-cigarette as a legitimate form of treatment.
E-cigarettes would still need to meet the standards of quality, safety, and efficacy expected of medicinal products.
If successful, certified vapes could be prescribed to smokers in Britain who wish to quit or reduce smoking.
According to the Department of Health and Social Care 2017 Tobacco Control Plan, e-cigarettes are less harmful to the health than tobacco.
The government believes that nicotine-bearing e-cigarettes can help people to stop smoking, and are just as effective as other cigarette alternatives, such as nicotine patches, chewing gum, nasal and mouth sprays and inhalers.
"The evidence is clear that e-cigarettes are less harmful to health than smoking tobacco and that nicotine-containing e-cigarettes can help people quit smoking for good. The updated guidance on licensing requirements we have published today is a strong first step towards availability of safe and effective licensed e-cigarette products," Dr June Raine, Chief Executive of the MHRA, said in a statement.
The agency will continue to support companies in developing safe and effective e-cigarette products, Dr Raine added, highlighting the importance of patient-centred care and access.
E-cigarettes regulated as medicines may be made available in strengths and volumes greater than those permitted under the Tobacco and Related Products Regulations 2016 (ie, containing more than 20 mg/ml nicotine, more than 2ml for single use cartridge/disposable products or more than 10ml for refill containers), explained the MHRA.
The World Health Organization says that e-cigarettes, which are the most common form of electronic nicotine delivery systems (ENDS), are harmful to health and are not safe.
The safest approach, according to the WHO, is not to use either tobacco products or their electronic counterparts.
"The scientific evidence regarding the effectiveness of ENDS as a smoking-cessation aid is still being debated. To date, in part due to the diversity of ENDS products and the low certainty surrounding many studies, the potential for ENDS to play a role as a population-level tobacco-cessation intervention is unclear," the WHO has reported.