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Chinese Journal of New Drugs

CSCD

ISTIC

PKU

ISSN：1003-3734

CN：11-2850/R

Frequency：Semimonthly

Website：http://www.newdrug.cn

Email：bianjibu@newdrug.cn

Postcode：100098

Articles12737

Citations124451

Funded4496

Impact Factor：2.35

Official Website

Articles

2022 No.24

Total 17 articles

Deepening the reform of the drug review and approval system and continuing to improve the research and innovation environmentKONG Fan-pu

2393-2397

Research on administration mode of enterprise legal person designated by overseas drug marketing authorization holdersJIANG Xiao-meng, WU Yi-fan, YANG Yue, SUN Li-hua

2398-2403

Reference value of PDUFA Act to improvement of the review ability of drug regulatory agenciesWU Yi-fan, ZHANG Wei, YU Wei, YANG Yue, LIU Zuo-ren

2404-2412

Regulatory considerations for synergistic protection of patents and data exclusivity for innovative therapeutic biologicsDU Xin, LUO Xing-xian, YANG Yue, SUN Li-hua

2413-2421

Research on definition of rare diseases in China and estimation of cumulative point prevalence based on OrphadataLI Zhuang-qi, YANG Pu, YANG Yue

2422-2428

The consideration behind America's Advancing process of OTC marketing pathwayTANG Tian-yu, WU Yi-fan, YANG Pu, LI Jing-ran, YANG Yue, XING Hua

2429-2436

Regulatory 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 Yue

2437-2443

Preliminary study on China's innovative biological product registration classificationGUO Qi-xiang, YANG Jing-shu, YANG Yue

2444-2451

Suggestions on establishing a regulatory coordination path for export only vaccines in ChinaYANG Yue, WU Yi-fan, HUAN Shi-tong, DU Heng, GAO Guang, YUAN Yuan

2452-2457

Comparison 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-sheng

2458-2464