Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products,and to establish a continuously improved registration classification system.Methods Based ...Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products,and to establish a continuously improved registration classification system.Methods Based on literature research,the specific classification methods,classification principles and considerations of biological registration in China,the United States and the European Union were studied to form a complete comparative analysis.Results and Conclusion It is recommended that the division between therapeutic and preventive use should be removed from the registration classification of biologics.The therapeutic,preventive and diagnostic use of the product should be limited as part of the product specification,and the registration should be classified according to the development of biotechnology,innovation,modification and bio-similar drugs.In addition,the supervision of registration of advanced therapeutic products should be different from that of traditional biologics.展开更多
文摘Objective To provide a theoretical basis for the adjustment of the registration classification of China’s biological products,and to establish a continuously improved registration classification system.Methods Based on literature research,the specific classification methods,classification principles and considerations of biological registration in China,the United States and the European Union were studied to form a complete comparative analysis.Results and Conclusion It is recommended that the division between therapeutic and preventive use should be removed from the registration classification of biologics.The therapeutic,preventive and diagnostic use of the product should be limited as part of the product specification,and the registration should be classified according to the development of biotechnology,innovation,modification and bio-similar drugs.In addition,the supervision of registration of advanced therapeutic products should be different from that of traditional biologics.
