UK MHRA issues clear guidelines to support the introduction of e-cigarettes to the market as a licensed therapy
On October 29, 2021, the MHRA issued an updated guidelines for the licensing of e-cigarettes and other inhaled nicotine-containing products as drugs". The updated guidelines were issued after consultation with the e-cigarette expert working group, which is composed of British experts Formed to provide independent supervision and advice to MHRA.
The updated guidelines provide more detailed information on the steps required to license e-cigarettes as pharmaceutical products. To be licensed, products need to meet expected drug quality, safety and efficacy standards. If successful, this may provide safe and effective prescription products for smokers who wish to quit or reduce smoking.
As stated in the 2017 Tobacco Control Plan of the Ministry of Health and Social Care, there is evidence that e-cigarettes are less harmful to health than smoking. Electronic cigarettes containing nicotine can help people quit smoking and are similar to other smoking cessation options. MHRA is committed to improving the public’s access to safe and effective licensed products.
Dr. June Raine, CEO of MHRA said:
There is evidence that e-cigarettes are less harmful to health than smoking, and e-cigarettes containing nicotine can help people quit smoking permanently. The updated guidelines on licensing requirements that we released today are a strong first step towards obtaining safe and effective licensed e-cigarette products.
MHRA will continue to support the company's development of safe and effective e-cigarette products and encourage the licensing of e-cigarette products as drugs to support patient-centered care and access.
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