On October 29, 2021, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its earlier guidance on the licensing of e-cigarettes and Other Inhaled Nicotine-containing Products (NCP) as medicines on its official government website, which means that the UK may become the first country in the world to implement medical product licensing for medical e-cigarettes.
The document states that manufacturers intending to manufacture medical e-cigarettes can contact the MHRA to submit a medical e-cigarette product license application to go through the same regulatory approval process as other drugs.
We will explain the requirements in detail in three installments, covering regulatory authorities, an overview of product requirements and marketing authorisation applications.
Regulators:
The MHRA is responsible for regulating not only consumer e-cigarettes, but also e-cigarettes and nicotine-containing products (NCP) as pharmaceutical products, with the aim of encouraging the licensing of e-cigarettes and other inhaled NCP as medicines and supporting companies to submit marketing authorization applications for these products. In addition to drug authorization, e-cigarettes that can be refilled and reused should also comply with the amended Medical Device Act of 2002.
For product applicants who are applying for a US Food and Drug Administration (FDA) pre-market Tobacco product application (PMTA), the MHRA can discuss which data may be relevant to the UK marketing authorisation application.
Product requirements Overview:
a) The standards of quality, safety and efficacy as defined in pharmaceutical regulations shall be met; b) It shall also comply with the general quality and safety standards for consumer e-cigarettes established by relevant national and international standards organizations; c) Depending on the design of the specific product, it may also be necessary to comply with UK medical device regulations; d) Nicotine content not exceeding 20mg/mL as prescribed by TRPR, disposable e-cigarette/disposable cartridge capacity not exceeding 2mL or refillable container capacity not exceeding 10mL.
Marketing Authorization Application (MAAs) :
a) All marketing authorization applications (MAAs) must be supported by a risk management plan. This must cover the identified and potential risks of the product and the measures to be implemented to minimise these risks, for which more information is provided in the Good Pharmacovigilance Guidelines (GpVP);
b) Guidelines relating to the quality, safety and effectiveness of medicinal products need to be taken into account when collecting dossiers on marketing authorization applications. The dossier will need to follow the format published in EudraLex Volume 2 of the EU Regulation on Medicines for Human Use - Instructions to Applicants for Legislation on Medicinal Products for Human Use and Guidance on the Regulation of Medicinal Products. In particular, Volume 2B - the introduction and content of the dossier, provides a useful overview of the data that make up marketing authorizations, with specific reference to the many guidelines that should be consulted when compiling data to support marketing authorizations;
c) There are a number of avenues for marketing authorisation, of which the "National 150-day process" is a fast-track procedure that can be used to efficiently apply for the sale of a drug in the UK.
The UK, as one of the best-selling markets for electronic cigarettes, has received the attention of many related enterprises (especially manufacturing enterprises), and it is recommended that this type of enterprise clarify the difference between the control rules of consumer electronic cigarettes and medical electronic cigarette products, so as to meet the compliance requirements of different types of products and smoothly export.
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