Quality Management System under the Drug Marketing Authorization Holder System
SUN Jing-lin1,2, YU Bo-yang1*
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China; 2. Department of Policy and Regulation, National Medical Products Administration, Beijing 100037, China
Abstract：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.
孙京林, 余伯阳. 药品上市许可持有人制度下的质量管理体系[J]. 中国药学杂志, 2020, 55(23): 1919-1922.
SUN Jing-lin, YU Bo-yang. Quality Management System under the Drug Marketing Authorization Holder System. Chinese Pharmaceutical Journal, 2020, 55(23): 1919-1922.
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