FDA“经口吸入含尼古丁药物产品的非临床试验”供企业用的指导原则介绍

Introduction to FDA’s Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products guidance for industry

在美国用于疾病防治的烟草制品或其衍生产品不属于烟草产品,按照药品或药械管理,其适应症包括尼古丁成瘾、预防复发或缓解其戒断症状。经口吸入含尼古丁的药物产品,包括用于防治疾病的电子烟都归属药品管理。为了支持经口吸入含尼古丁药物产品的开发和准入,美国食品药品管理局(FDA)于2020年10月发布了"经口吸入含尼古丁药物产品的非临床试验"供企业用的指导原则,提出了对这类产品的非临床信息的建议,主要对其非临床毒理学研究的试验特点、一般原则和需要特别注意的问题做了详细地阐述。我国目前在法律上对电子烟监管的归属还不明确,也没有类似的非临床研究的技术指导原则。详细介绍FDA该指导原则,期待对我国尼古丁电子烟的监管归属和经口吸入含尼古丁药物产品的非临床研究和监管有所启迪。

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.