Progress and prospect of regulatory science in cell and gene therapy productsGAO Jian-chao, WEI Wei, ZHANG Min, GAO Chen-yan105-108
Regulatory considerations for using surrogate endpoints to accelerate the development of COVID-19 vaccinesYANG Jing-shu, DING Sheng, YANG Yue119-124
The 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 Yue125-131
Research 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-ying132-141
Application of patient-reported outcome measurement tools in drug development and regulatory approval in the USGUAN Hong-feng, YANG Li-na, YANG Yue142-146
Regulatory considerations about accelerating the approval of domestic HPV vaccinesYANG Jing-shu, DING Sheng, ZHANG Ya-juan, YANG Yue147-154
Analysis of China regulatory strategy on post-approval changes of pharmaceutical productsLI Cheng, CHEN Gui-liang155-159
Study on data management requirements of drug pre-approval inspectionYAN Ruo-xi, CAO Yi, DONG Jiang-ping160-164
Analysis of some characteristics and management of drug changes in the whole life cycleLI Shuai, MEI Ni, CHEN Gui-liang165-171