目的 药品质量关系到每个人的身体健康和生命安全,2019年颁布的新修订的《中华人民共和国药品管理法》,确立了药品上市许可持有人制度,要求药品上市许可持有人建立质量体系,笔者旨在对行业建立质量管理体系提供参考。方法 作者结合相关文献的检索和分析,回顾了药品质量管理的发展历程,对药品质量管理体系的范围和内容等进行分析。结果与结论 上市许可持有人应围绕质量管理体系的范围、目标、设计和内容、管理职责、持续改进等方面开展工作,逐步建立并完善质量管理体系。

OBJECTIVE The drug quality is related to the health and life safety of everyone. The newly revised Pharmaceutical Administration Law of the People's Republic of China was promulgated in 2019 and it takes the drug marketing authorization holder (MAH) system into full swing. The MAH should establish the quality management system. The aim of the author is to provide reference for the industry establishing the quality management system. METHODS The author reviews the development of drug quality management, analyzes and discusses the scope and content of the quality management system of pharmaceuticals based on the literature review and analysis. RESULTS AND CONCLUSION The MAH should work on the scope, objectives, design and content, management responsibilities, continuous improvement of the quality management system, and gradually establish and improve the quality management system.