新型烟草制品风险评估框架要求研究进展及建议

Research progress on risk assessment framework for novel tobacco products and recommendation for China

针对新型烟草制品需要开展健康风险评估的要求,综述了美国FDA和欧盟等的相关法规、各烟草公司公开的申请资料等相关文献,分析了各项资料的特点,进而提出了适用于我国的新型烟草制品风险评估要求框架,建议我国按照个体、人群和环境3层框架开展对新型烟草制品的风险评估。

Aiming at the scientific requirements of health risk assessment for novel tobacco products,this review summarized the relevant documents,such as relevant laws and regulations issued by regulatory agencies such as FDA of the United States,TPD of EU and the application materials published by major international tobacco companies.The principles and other characteristics of those documents were analyzed.Furthermore,a suitable risk assessment framework of novel tobacco products for China was put forward.This framework proposed that China should carry out the risk assessment of novel tobacco products according to a three-layer risk assessment framework,including smoking individual,population and the environmental risks.