Analysis of Real-Time Review of Drug Applications in the United States and Its Enlightenment to China
JIANG Rong1, ZHENG Yan-ying2, GE Wen-xia1, SUN Yuan-yuan3, SHAO Rong1*
1. The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China; 2. Institute of Epidemiology and Healthcare, University College London, London WC1E 6BT, UK; 3. Wuxi Higher Health Vocational Technology School, Wuxi 214028, China
Abstract：OBJECTIVE To analyze the implementation of the real-time review of drug application system in the United States and provide a reference for the reform of the drug registration review system in China. METHODS Through the literature and case studies, the article analyzed the framework, implementation process, and effectiveness of the FDA's real-time review of drug application system. RESULTS It is found that the system includes real-time oncology review (RTOR) and assessment aid (AAid). RTOR provides a standardized data analysis process and the steps of "pre-submission" and "pre-analysis", while AAid is based on the FDA multidisciplinary review template. By the end of 2019, 27 projects have been approved through the system. CONCLUSION Druing the reforming process of drug review system in China, it is recommended to strengthen the top-level design of policies, explore diversified special review methods, and actively promote data standardization and communication and interaction, so as to improve the review efficiency and accelerate the marketing of medicines with clinical value.
蒋蓉, 郑燕影, 葛文霞, 孙圆圆, 邵蓉. 美国药品即时审评制度分析及对我国的启示[J]. 中国药学杂志, 2020, 55(23): 1985-1989.
JIANG Rong, ZHENG Yan-ying, GE Wen-xia, SUN Yuan-yuan, SHAO Rong. Analysis of Real-Time Review of Drug Applications in the United States and Its Enlightenment to China. Chinese Pharmaceutical Journal, 2020, 55(23): 1985-1989.
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2020, Vol. 55 
