美国OTC药物中防晒产品的管理及相关启示

Management of Sunscreen Products as an OTC Drug in the U.S. and its Inspiration for China

目的:了解美国OTC药物中防晒产品的监管要求、技术要求和发展方向,为我国相关产品的监管提供参考。方法:对美国防晒产品相关法规和OTC专论内容进行总结,并对最新修订情况、关注热点和研究进展等进行追踪。在此基础上,结合我国法规要求和管理现状进行对比分析。结果:美国对于防晒产品的管理较为严格,在OTC专论中详细规定了防晒剂使用、标签标识、防晒测试等内容。近年来,美国积极推进《防晒创新法案》(Sunscreen Innovation Act),并启动OTC专论修订工作,包括防晒剂再评估、标签要求修订、对产品剂型的调研和评估,以及对防晒剂透皮吸收和纳米防晒剂的关注等。结论:美国对于OTC专论的修订以及相关研究工作值得关注,建议充分借鉴美国OTC专论等国际法规标准中的技术要求,结合我国监管实际,建立起关于防晒产品的科学完整的技术体系和评价体系。

Objective: To reveal the regulatory and technical requirements and development of sunscreens as an OTC drug in the U.S. so as to provide references for the supervision of such products in China. Methods: The regulations and OTC monograph about sunscreen in the U.S. were summarized, and the latest revision, concerned issues and research progress were followed. On this basis, a comparative analysis with the regulatory requirements and status in China was conducted. Results: The study found that the U.S. has stricter regulation of sunscreen products, with detailed regulations on sunscreen use, labeling and efficacy test in the sunscreen OTC monograph. In recent years, the U.S. has actively promoted a Sunscreen Innovation Act and initiated the revision of the monograph, including sunscreen re-evaluation, revision of labeling requirements, investigation and evaluation of dosage forms, as well as some concerns about transdermal absorption of sunscreen ingredients and nanomaterials. Conclusion: The revision of sunscreen OTC monograph and related research work are worthy of attention. It is suggested that our government take the U.S. monograph and other foreign standards as technical references, combining with China’s regulatory practice, to build a scientific and complete technical system and evaluation system for sunscreen products in China.