1Deepening the reform of the drug review and approval system and continuing to improve the research and innovation environmentKONG Fan-pu2393-23972Research on administration mode of enterprise legal person designated by overseas drug marketing authorization holdersJIANG Xiao-meng, WU Yi-fan, YANG Yue, SUN Li-hua2398-24033Reference value of PDUFA Act to improvement of the review ability of drug regulatory agenciesWU Yi-fan, ZHANG Wei, YU Wei, YANG Yue, LIU Zuo-ren2404-24124Regulatory considerations for synergistic protection of patents and data exclusivity for innovative therapeutic biologicsDU Xin, LUO Xing-xian, YANG Yue, SUN Li-hua2413-24215Research on definition of rare diseases in China and estimation of cumulative point prevalence based on OrphadataLI Zhuang-qi, YANG Pu, YANG Yue2422-24286The consideration behind America's Advancing process of OTC marketing pathwayTANG Tian-yu, WU Yi-fan, YANG Pu, LI Jing-ran, YANG Yue, XING Hua2429-24367Regulatory considerations for clinical evaluation of HPV vaccines by using immunological surrogate endpointHE Xiang-chuan, YANG Jing-shu, LIU Jing-wen, YUAN Yuan, HUAN Shi-tong, DU Heng, YANG Yue2437-24438Preliminary study on China's innovative biological product registration classificationGUO Qi-xiang, YANG Jing-shu, YANG Yue2444-24519Suggestions on establishing a regulatory coordination path for export only vaccines in ChinaYANG Yue, WU Yi-fan, HUAN Shi-tong, DU Heng, GAO Guang, YUAN Yuan2452-245710Comparison of the selection and management of reference medicinal products of chemical generic drugs in China and AmericaYOU Zheng-kun, SUN Chun-meng, LIU Yi-lin, GUO Zhi-xin, TU Jia-sheng2458-246411Development status of cloud application for drug registrationMO Run-yi2465-246812Research on biologics data protection system in Japan based on the empirical study of infliximabYAO Xue-fang, DING Jin-xi2469-247413Considerations on the support of converting traditional Chinese medicine preparations of medical institutions into new traditional Chinese medicine using real world evidenceLI Pei, CHEN Yu-wen2475-248014Technical considerations for implementation of ICH M4 E in ChinaZHAI Yun, QIAN Si-yuan, ZHOU Heng, XIAO Fang, SUN Tao, XIE Song-mei2481-248515Immunoregulatory role of mesenchymal stem cells in acute graft-versus-host diseaseWEI Xuan, CI Xiao-yan, YAN Feng-ying, ZHU Xiao-fan, ZHANG Ying-chi2486-249116Progress in immune checkpoint inhibitors in the treatment of advanced hepatocellular carcinomaRONG Chen, LIU Ran-jia, XU Ye, CUI Xiang-li2492-249717Cost-effectiveness of camrelizumab added to chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinomaLI Li-zong, ZHAO Lei, ZHONG Xue, HUANG Jing, HUANG Lin, FENG Yu-fei2498-2503 