Catalogue of On-Site Inspection Varieties for the Drug Clinical Trial Data
Catalogue of On-site Inspection Varieties for the Drug Clinical Trial Data
No. / Acceptance No. / Drug Name / Applicant Unit / Responsible Person of Application Unit / Clinical Trial Group Leader Unit / Principal investigator / Contract Research Organization / Responsible Person of Contract Research Organization / Institution of Phase I /BE Clinical Trial / Principal Investigators of Phase I/BE / Phase I /BE Analytical Testing Unit / Principal Investigators of Phase I/BE Analytical Testing / Contract Research Organization of Phase I/BE / Phase I/BE Responsible Person of Contract Research Organization1 / CXSS1500020 / Pegylated recombinant human consensus interferon-α variant (PEG-IFN-SA) / Beijing Kawin Technology Share-Holding Co., Ltd.; Chongqing Fujin Bio-Pharmaceutical Co., Ltd. / Zhou Desheng / Beijing Ditan Hospital, Capital Medical University / Cheng Jun / Beijing Stemexcel Technology Co., Ltd / Li Ziyi / West China Hospital, Sichuan University, The First Hospital of Jilin University / Zheng Li, Niu Junqi, Ding Yanhua / Tianjin Institute of Pharmaceutical Research, Chongqing Fujin Bio-Pharmaceutical Co., Ltd. / Cai Yongming, Fan Kai / / / /
2 / CYHS1600191 / Bendamustine hydrochloride for injection / Jiangsu Simcere Pharmaceutical Company / Ren Jinsheng / Ruijin Hospital, Shanghai Jiaotong University Medical College / Shen Zhixiang / / / / / The First Affiliated Hospital with Nanjing Medical University / Xu Wei / Frontage Laboratories, Inc. / Ma Lili / / / /
3 / CYHS1600193 / Bendamustine hydrochloride for injection / Chia Tai Tianqing Pharmaceutical Group Co., Ltd / Xie Bing / Sun Yat-sen University Cancer Center / Huang Huiqiang / / / / / Sun Yat-sen University Cancer Center / Huang Huiqiang / Sun Yat-sen University Cancer Center / Li Su / / / /
4 / JXHL1700001 / Elbasvir/grazoprevir tablet / MSD Merck Sharp & Dohme AG;MSD International GmbH;Schering-Plough Labo NV; Merck Sharp & Dohme (China) Co., Ltd. / Li Zhengqing / Peking University People’s Hospital / Wei Lai / / / / / The Third Hospital of Peking University / Li Haiyan / Wuxi Apptec Shanghai Co Ltd / Zhang Renjie / / / /
5 / CXSS1600011 / Human Coagulation Factor VIII / Chengdu Rongsheng Pharmaceutical Co., Ltd / Fu Daoxing / West China Hospital, Sichuan University / Pan Ling / Beijing CTSmed Co., Ltd / Luo Yanju / West China Hospital, Sichuan University / Pan Ling / Jiangsu Tripod Preclinical Research Laboratories Co., LTD / Zhang Xuefeng / Beijing CTSmed Co., Ltd / Luo Yanju
6 / JXHL1700039 / Ceritinib capsule / Novartis Europharm Limited;Novartis Pharma Stein AG; China Novartis Institutes for BioMedical Research Co., Ltd / CHRISTOPHER SNOOK / Guangdong General Hospital / Wu Yilong / / / / / / / / / / / / / / / /
7 / JXHS1700009 / Buprenorphine hydrochloride sublingual tablet / Indivior UK LimitedReckitt Benckiser Healthcare (UK) Ltd; iPhase Pharmaceutical Services / Liu Hongjun / The Second Xiangya Hospital of Central South University / Hao Wei / Medical statistics department, NCCD / Li Wei / Affiliated Hospital of Academy of Military Medical Sciences of People's Liberation Army of China / Liu Zeyuan / Peking Union Medical College Hospital / Jiang Ji / Medical statistics department, NCCD / Li Wei
8 / JXHS1700010 / Buprenorphine hydrochloride sublingual tablet / Indivior UK LimitedReckitt Benckiser Healthcare (UK) Ltd; iPhase Pharmaceutical Services / Liu Hongjun / The Second Xiangya Hospital of Central South University / Hao Wei / Medical statistics department, NCCD / Li Wei / Affiliated Hospital of Academy of Military Medical Sciences of People's Liberation Army of China / Liu Zeyuan / Peking Union Medical College Hospital / Jiang Ji / Medical statistics department, NCCD / Li Wei
9 / CXSS1700004 / Human Prothrombin Complex / Shanxi Kangbao Biological Product Co., Ltd. / Zhou Manxiang / The First Affiliated Hospital of Zhejiang University School of Medicine / Jin Jie / Hangzhou Tigermed Consulting Co., Ltd / Zhao Jiahong / / / / / / / / / / / /
10 / JXSS1700003 / Ranibizumab injection / Novartis Pharma Schweiz AG;Novartis Pharma Stein AG;Beijing Novartis Pharma Ltd. / Lu Siqi / Peking University Third Hospital, Beijing Tongren Hospital, Capital Medical University / Ma Zhizhong, Zhang Feng / / / / / / / / / / / / / / / /
11 / JXSS1700002 / Ranibizumab injection / Novartis Pharma Schweiz AG;Novartis Pharma Stein AG;Beijing Novartis Pharma Ltd. / Lu Siqi / Peking University Third Hospital, Beijing Tongren Hospital, Capital Medical University / Ma Zhizhong, Zhang Feng / / / / / / / / / / / / / / / /
12 / JXHL1700083 / Regorafenib tablet / Bayer Pharma AG;Bayer Pharma AG;Bayer HealthCare AG / Jiang Wei / No. 81 Hospital of PLA / Qin Shukui / Covance Pharmaceutical R&D (Beijing) Co., Ltd / Guo Hong / / / / / / / / / / / /
13 / JXHS1700024 / Indacaterol/glycopyrrolate powder for oral inhalation / Novartis Europharm Limited;Novartis Pharma Stein AG; China Novartis Institutes for BioMedical Research Co., Ltd / Christopher Snook / The First Affiliate Hospital of Guangzhou Medical University / Zhong Nanshan, Zhang Nuofu / / / / / Teda International Cardiovascular Hospital / Hou Jie / WuXi AppTec Shanghai / Qu Lanjin / / / /
14 / CXSS1500016 / Recombinant human insulin injection / Hefei Tianmai Biotechnology Development Co., Ltd. / Gao Xiaoming / / / / / / / / / West China Hospital, Sichuan University / Yu Ye Rong / Covance Pharmaceutical R&D (Shanghai) Co., Ltd / Shi Lihong / Kun Tuo Medical Research and Development (Beijing) Co., Ltd. / Lu Rong
15 / JXHS1600049 / Exenatide extended-release for injectable suspension / AstraZeneca Investment (China) Co., Ltd. / Wang lei / Peking University People's Hospital / Ji Linong / / / / / Peking University First Hospital / Guo Xiaohui / Bioanalysis Department of WuXi AppTec Shanghai / Hu Jianjun / / / /
16 / CYHB1690001 / Atorvastatin calcium tablets / Beijing Jialin Pharmaceutical Co., Ltd. / Liu Wei / / / / / / / / / General Hospital of Ningxia Medical University / Dang Hongwan / Shanghai Center for Drug Metabolism and Pharmacokinetics Research / Zhong Da Fang / / / /
17 / CYHB1690002 / Atorvastatin calcium tablets / Beijing Jialin Pharmaceutical Co., Ltd. / Liu Wei / / / / / / / / / General Hospital of Ningxia Medical University / Dang Hongwan / Shanghai Center for Drug Metabolism and Pharmacokinetics Research / Zhong Da Fang / / / /
18 / CYSB1600166 / Recombinant Hepatitis B Vaccine (Hansenula polymorpha) / Hualan Biological Engineering Inc. / An Kang / Henan Center for Disease Control and Prevention / Xia Shengli / / / / / / / / / / / / / / / /
19 / JYHB1700044 / Bortezomib for Injection / Janssen-Cilag International N.V.BSP Pharmaceuticals S.r.l.Janssen pharmaceutica N.V.; Xian Janssen Pharmaceutical Ltd / Asgar Rangoonwala / N/A (International multicenter clinical trial) / / / / / / / / / / / / / / / / / /
20 / JYHB1700045 / Bortezomib for Injection / Janssen-Cilag International N.V.BSP Pharmaceuticals S.r.lJanssen pharmaceutica N.V.； Xian Janssen Pharmaceutical Ltd / Asgar Rangoonwala / N/A (International multicenter clinical trial) / / / / / / / / / / / / / / / / / /
21 / CYZB0701270 / Fufang Danshen tablets / Guangzhou Baiyun Mountain and Hutchison Whampoa Ltd.; / Du Zhiqiang / Hunan Academy of Chinese Medicine, Traditional Chinese Medicine Hospital of Guangdong Province, Beijing Dongzhimen Hospital / Zhou Shen, Luo Xiaodong, Tian Jinzhou / Guangzhou Boji Medical Biotechnological co., Ltd, Beijing Sinocro PharmaScience Co., Ltd. / Tan Bo, Liang Xiao / / / / / / / / / / / /
22 / CYHS1590026 / Nifedipine sustained-release tablet (I) / Qingdao Huanghai Pharmaceutical Co., Ltd. / Wang Zekai / / / / / / / / / Fuwai Hospital Chinese Academy of Medical Sciences / Tian Lei / Fuwai Hospital Chinese Academy of Medical Sciences / Tian Lei / / / /
23 / CXHS1400199 / Zaltoprofen tablets / Beijing Sihuan Kebao Pharmaceutical Co., Ltd. / Zhang Jianli / Guangdong General Hospital / Zhang xiao / InCROM CHINA / Ni Na / Fourth Military Medical University / Wen Aidong / Shanghai Center for Drug Metabolism and Pharmacokinetics Research / Zhong Dafang / InCROM CHINA / Ni Na
24 / JXHS1500076 / Lacosamide tablet / UCB Pharma SA;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Huashan Hospital / Hong Zhen / PAREXEL China Co., Ltd. / Marina Tang / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Yu Qiaoling / PAREXEL China Co., Ltd. / Wang Yueling
25 / JXHS1500077 / Lacosamide tablet / UCB Pharma SA;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Huashan Hospital / Hong Zhen / PAREXEL China Co., Ltd. / Marina Tang / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Yu Qiaoling / PAREXEL China Co., Ltd. / Wang Yueling
26 / JXHS1500078 / Lacosamide tablet / UCB Pharma SA;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Huashan Hospital / Hong Zhen / PAREXEL China Co., Ltd. / Marina Tang / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Yu Qiaoling / PAREXEL China Co., Ltd. / Wang Yueling
27 / JXHS1500079 / Lacosamide tablet / UCB Pharma SA;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Huashan Hospital / Hong Zhen / PAREXEL China Co., Ltd. / Marina Tang / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Yu Qiaoling / PAREXEL China Co., Ltd. / Wang Yueling
28 / JXHS1500081 / Rotigotine transdermal patch / UCB Manufacturing Ireland Ltd.;LTS Lohmann Therapie-Systeme AG;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Peking Union Medical College Hospital, Chinese Academy of Medical Sciences / Zhang Zhenxin / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Zuo Ming / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming
29 / JXHS1500082 / Rotigotine transdermal patch / UCB Manufacturing Ireland Ltd.;LTS Lohmann Therapie-Systeme AG;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Peking Union Medical College Hospital, Chinese Academy of Medical Sciences / Zhang Zhenxin / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Zuo Ming / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming
30 / JXHS1500083 / Rotigotine transdermal patch / UCB Manufacturing Ireland Ltd.;LTS Lohmann Therapie-Systeme AG;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Peking Union Medical College Hospital, Chinese Academy of Medical Sciences / Zhang Zhenxin / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Zuo Ming / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming
31 / JXHS1500084 / Rotigotine transdermal patch / UCB Manufacturing Ireland Ltd.;LTS Lohmann Therapie-Systeme AG;Aesica Pharmaceuticals GmbH;UCB Trading (Shanghai) Co., Ltd / VERONIQUE TOULLY / Peking Union Medical College Hospital, Chinese Academy of Medical Sciences / Zhang Zhenxin / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming / Xuhui District Central Hospital / Liu Yun / Frontage Laboratories, Inc. / Zuo Ming / PAREXEL China Co., Ltd. PAREXEL China Co., Ltd. / Wei Changming