1Progress and prospect of regulatory science in cell and gene therapy productsGAO Jian-chao, WEI Wei, ZHANG Min, GAO Chen-yan105-1082Drug toxicity database and regulatory scienceGENG Xing-chao, LI Bo109-1183Regulatory considerations for using surrogate endpoints to accelerate the development of COVID-19 vaccinesYANG Jing-shu, DING Sheng, YANG Yue119-1244The global vaccine expansion production model from the perspective of COVID-19 pandemic: inspirations for innovation of China's vaccine regulationYANG Li-na, GUAN Hong-feng, SUN Ying-nan, LUO Xing-xian, YANG Yue125-1315Research on the new drug marketing approval procedures based on surrogate endpoints in the US and EU and its enlightenment to ChinaYANG Li, WEI Yan-yi, WU Di, CHEN Yu-wen, WANG Zu-guang, YANG Ze-ying132-1416Application of patient-reported outcome measurement tools in drug development and regulatory approval in the USGUAN Hong-feng, YANG Li-na, YANG Yue142-1467Regulatory considerations about accelerating the approval of domestic HPV vaccinesYANG Jing-shu, DING Sheng, ZHANG Ya-juan, YANG Yue147-1548Analysis of China regulatory strategy on post-approval changes of pharmaceutical productsLI Cheng, CHEN Gui-liang155-1599Study on data management requirements of drug pre-approval inspectionYAN Ruo-xi, CAO Yi, DONG Jiang-ping160-16410Analysis of some characteristics and management of drug changes in the whole life cycleLI Shuai, MEI Ni, CHEN Gui-liang165-17111Consideration on formulation and implementation of administrative documents ICH M4 Module 1 of ChinaXIAO Fang, WEN Bao-shu, HE Yu-hong, DU Hai-ru, SUN Tao, YU Hong, ZHAI Yun, ZHOU Heng, XIE Song-mei172-17612An analysis of audit checklist of Pharmaceutical Inspection Co-operation Scheme ( PIC/S)SHI Tian-fang, CAO Yi, DONG Jiang-ping, YANG Yue177-18213Study on marketing pathway and supervision of OTC drugs in the United StatesGUAN Hong-feng, LI Yan-rong, YANG Na, YANG Yue183-18814Electronic drug labeling and its development statusYU Wei, MO Run-yi189-19215Research on the ability and quality of foreign drug regulatory talents from the perspective of regulatory science and thoughts on talent cultivation in our countryWANG Zhi-wei, ZHENG Xin-xin, MAO Ning-ying, LI Jun193-200 