官方請(qǐng)求加快電子香煙藥物許可審核

官方請(qǐng)求加快電子香煙藥物許可審核

電子煙是一種模仿卷煙的電子產(chǎn)品，它是通過(guò)霧化等手段，將尼古丁等變成蒸汽后，讓用戶吸食的一種產(chǎn)品。在一個(gè)新的事物研發(fā)的時(shí)候，總是伴隨著爭(zhēng)議與期待，到底電子香煙能否成為“資深煙民”的戒煙良藥？

測(cè)試中可能遇到的詞匯和知識(shí)：

regulatory 監(jiān)管的

inadvertently 非故意地

nicotine 尼古丁

inhaler 吸入器

pipeline 渠道

Officials call for faster medicinal licensing of ecigarettes （599 words）

By Mark Odell

Health officials have called for a review of ecigarette licensing to speed up their availability on prescription after concluding they can help smokers quit.

A report commissioned by Public Health England estimated they are 95 percent less harmful than tobacco but observed no product has secured approval to make it available on prescription in the five years since procedures were put in place to license tobacco replacement products.

“Much of England's strategy of tobacco harm reduction is predicated on the availability of medicinally licensed products that smokers want to use,” said the report.

It called for a review of the licensing process put in place by the UK Medicines and Healthcare products Regulatory Agency in 2010,citing concerns the current cost of obtaining a licence would limit innovation and favour products produced by big tobacco companies “The fact that no licensed ecigarettes are yet on the market suggests that the licensing route to market is not commercially attractive. The absence of non-tobacco industry products going through the MHRA licensing process suggests that the process is inadvertently favouring larger manufacturers……which is likely to inhibit innovation in the prescription market,” the report said.Last year,a new type of nicotine inhaler backed by British American Tobacco won MHRA clearance. However,the product,Voke,is not yet commercially available in the UK and is not defined as an ecigarette because it uses the propellants found in asthma inhalers to deliver nicotine.

According to the report,BAT has submitted an ecigarette product for approval and rival products are also in the pipeline but “it is unclear at what stage the applications are”.

The one-off cost of the application process is estimated by the MHRA as between £252,000 and £390,000,along with annual costs of between £65,000 and £249,000 per product.

“A review of the……licensing process therefore seems appropriate,including manufacturers' costs and potential impact. This could include a requirement for MHRA to adapt the processes and their costs to enable smaller manufacturers to apply,and to speed up the licensing process,” the report said.

The report also warned that new EU legislation,which is likely to come into force in the UK in 2017,would take ecigarettes containing high nicotine doses off the market “potentially affecting heavier smokers”.

Among other conclusions,the study by teams from King's College London and Queen Mary London found the message that ecigarettes are much less harmful than tobacco was not getting through to smokers.

Instead,research questioning their safety has contributed to recent slowing demand.

“Ecigarettes are not completely risk free but compared to smoking,evidence shows they carry just a fraction of the harm,” said Professor Kevin Fenton,director of health and wellbeing at Public Health England. “The problem is people increasingly think they are at least as harmful and this may be keeping millions of smokers from quitting.”

Local services that help people to stop smoking should “look to support ecigarette users in their journey to quitting”.

However,a report last year by the World Health Organisation said it was too early to conclude whether ecigarettes helped smokers quit. It also said they should be banned in public buildings.

There is also concern that the use of ecigarettes would encourage young people to start smoking. The report by PHE said there was “no evidence” to support this.

The WHO report found there were not enough data to establish whether the trends for the growing popularity of ecigarettes in the UK and the gradual decline in nicotine use were “causally related”.