在美國用于疾病防治的煙草制品或其衍生產(chǎn)品不屬于煙草產(chǎn)品，按照藥品或藥械管理，其適應(yīng)癥包括尼古丁成癮、預(yù)防復(fù)發(fā)或緩解其戒斷癥狀。經(jīng)口吸入含尼古丁的藥物產(chǎn)品，包括用于防治疾病的電子煙都歸屬藥品管理。為了支持經(jīng)口吸入含尼古丁藥物產(chǎn)品的開發(fā)和準(zhǔn)入，美國食品藥品管理局（FDA）于2020年10月發(fā)布了“經(jīng)口吸入含尼古丁藥物產(chǎn)品的非臨床試驗”供企業(yè)用的指導(dǎo)原則，提出了對這類產(chǎn)品的非臨床信息的建議，主要對其非臨床毒理學(xué)研究的試驗特點、一般原則和需要特別注意的問題做了詳細地闡述。我國目前在法律上對電子煙監(jiān)管的歸屬還不明確，也沒有類似的非臨床研究的技術(shù)指導(dǎo)原則。詳細介紹FDA該指導(dǎo)原則，期待對我國尼古丁電子煙的監(jiān)管歸屬和經(jīng)口吸入含尼古丁藥物產(chǎn)品的非臨床研究和監(jiān)管有所啟迪。

Tobacco products or their derivatives used for disease control in the United States belong to drug or device regulation, and their indications include nicotine addiction, relapse prevention, or relief of nicotine withdrawal symptoms. Such products do not belong to tobacco product regulation. Orally inhaled nicotine-containing Drug Products, including nicotine-containing e-cigarettes for disease prevention and treatment, belongs to drug regulation. In order to support the development and approval of orally inhaled nicotine-containing drug products, FDA issued the Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products guidance for industry in October 2020. The guidance provides suggestions on the nonclinical information of such products, mainly elaborating the test characteristics, general principles and problems needing special attention of nonclinical toxicology research. At present, the legal ownership of e-cigarette regulation in China is not clear, and there is no similar technical guidance of nonclinical research. The guidance of FDA is introduced in detail, and it is expected to enlighten the regulatory attribution of nicotine-containing e-cigarettes and the non clinical research and regulation of orally inhaled nicotine-containing drug products in China.

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