Catalogue of On-site Inspection Varieties for the Drug Clinical Trial Data Drug Name Application Unit Person of Application Unit Clinical Trial Group Leader Unit Principal Contract Research Organization Person of Contract Research Institution of Phase I/BE Clinical Trial Principal Investigator of Phase I/BE Phase I /BE Analytical Testing Unit of I /BE Testing Principal Investigator f I /BE Phase I /BE Person of Contract Research 1 Tenofovir Disoproxil Fumarate Tablets Qilu Co., Ltd. Li Botao / / / / National Institution of Drug Clinical Trial, The Third Xiangya Hospital of Central South University Yang Guoping Bioanalytical Service Department, Wuxi Apptec New Drug Development Co., Ltd. Shanghai Tian Chunling / / 2 Solution for Injection UCB Trading (Shanghai) Co., Ltd. Veronique Toully / / / / Drug Clinical Trial Institution of Shanghai Xuhui District Central Hospital Liu Yun Frontage Laboratories (Shanghai) Co., Ltd. Zuo Ming PAREXEL Internal GmbH Huang Manli 3 Solution for Injection AbbVie Ltd Tony (Ou Silang) Peking University People’s Hospital =Zhang Jianzhong / / / / / / / / 4 Insulin Glargine Injection Deutschland Gao Lingyun (Peter Guenter) Beijing Children’s Hospital, Capital Medical University Gong Chunxiu / / Children's Hospital Affiliated to Capital Institute of Pediatrics, Peking Union Medical College Chen Xiaobo, Zhao Weigang, Gong Chunxiu Q2 Solutions (Beijing) Pharmaceutical R&D Co., Ltd. / / / Trial Aventis
7 Injection MSD R&D (China) Co., Ltd. Li Zhengqing Peking University Hospital, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Wu Xinmin, Yu Buwei / / Zhongshan Hospital, Fudan University Li Xuening QUINTILES B.V. Elsa Artola / / 8 Injection MSD R&D (China) Co., Ltd. Li Zhengqing Peking University Hospital, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Wu Xinmin, Yu Buwei / / Zhongshan Hospital, Fudan University Li Xuening QUINTILES B.V. Elsa Artola / / 9 Sorafenib Tosylate Tablets Bayer HealthCare AG Jiang Wei Affiliated Cancer Hospital , Tianjin Medical University Shi Yuankai APEX China Co., Ltd. Mu Nan / / / / / / 10 tablets Roche AG;Roche S.p.A. ;Shanghai Roche Co Limited Zuo Min Beijing Tumor Hospital Guo Jun / / Sun Yat-Sen University Cancer Hospital, Beijing Tumor Hospital Zhang Xiaoshi, Guojun Covance Pharmaceutical R&D (Shanghai) Co., Ltd. Wei Guolan / /
11 Albuvirtide for injection Nanjing Frontier DONG XIE Beijing Youan Hospital, Capital Medical University Wu Hao Beijing Konted Medical Technology Co., Ltd. Ting Beijing Youan Hospital, Capital Medical University Wu Hao Biological Sample Analysis Laboratory, Beijing Hospital Jin Ronghua Beijing Konted Medical Technology Co., Ltd. Ting 12 Etanercept injection Pfizer Limited Wu Xiaobin / / / / Peking University First Hospital Lv Yuan Celerion, Inc. Ruhn, Ph.D / / 13 Etanercept injection Pfizer Limited Wu Xiaobin / / / / Peking University First Hospital Lv Yuan Celerion, Inc. Peggy Ruhn, Ph.D. / / 14 Injection Novartis Europharm Limited Ma Tao Affiliated Hospital of Guangzhou Medical University Zhong Nanshan, Li Jing / / Beijing Hospital Affiliated to Ministry of Public Health Li Kexin BURECO AG Now synlab pharma institute Ines Kaiser / / 15 Hepatitis B C virus/HIV Type 1 Nucleic Acid Detection Kit (PCR - fluorescent probe method) Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. Qiu Zixin / / / / National Institutes for Food and Drug Control, Central Station of Xiamen, Henan Red Cross Blood Center, Central Blood Station of Qingdao Xu Sihong, Ou Shanhai, Fang Jianhua, Yang Zhongsi Covance Pharmaceutical R&D (Shanghai) Co., Ltd., Clinical Lab of Beijing Red Cross Blood Center, National Institutes for Food and Drug Blood Station of Xiamen, Henan Red Cross Blood Center, Central Blood Station of Qingdao Wei Guolan, Ge Xu Sihong, Ou Shanhai, Fang Jianhua, Yang Sisi / / 16 Saxagliptin + Metformin AstraZeneca AB Wang Lei / / / / Peking University Third Hospital Li Haiyan Bioanalytical Service Department, Wuxi Apptec New Drug Chen Weikao / /
tablets (I) Development Co., Ltd. Shanghai 17 Saxagliptin + Metformin tablets (II) AstraZeneca AB Wang Lei / / / / Peking University Third Hospital Li Haiyan Bioanalytical Service Department, Wuxi Apptec New Drug Development Co., Ltd. Shanghai Chen Weikao / / 18 Linagliptin + Metformin tablets Boehringer Ingelheim (China) Investment Co., Ltd. David Preston, Chen Xiaoxiang Shanghai Ruijin Hospital Ning Guang Theorem Technology Consulting Co.,Ltd. You Jianguo Peking University First Hospital Cui SGS CEPHAC EUROPE S.A.S./Covance Laboratories Limited Covance: E Ferguson ICON Clinical Research Limited Zhang Xiaokang 19 Linagliptin + Metformin tablets Boehringer Ingelheim (China) Investment Co., Ltd. David Preston, Chen Xiaoxiang Shanghai Ruijin Hospital Ning Guang Theorem Technology Consulting Co.,Ltd. You Jianguo Peking University Hospital Cui Yimin SGS CEPHAC EUROPE S.A.S./Covance Laboratories Limited Covance: E Ferguson ICON Clinical Research Limited Zhang Xiaokang 20 tablets Bayer HealthCare AG Jiang Wei Zhongshan Hospital, University Wang Yuqi Covance R&D (Beijing) Co., Ltd., Shanghai Branch Li Ling / / / / / / 21 tablets Bayer HealthCare AG Wei Zhongshan Hospital, Fudan University Wang Yuqi Covance R&D (Beijing) Co., Ltd., Shanghai Branch Li Ling / / / / / / 22 tablets Bayer HealthCare AG Jiang Wei Zhongshan Hospital, Fudan University Wang Yuqi Covance R&D (Beijing) Co., Li Ling / / / / / /
Ltd., Shanghai Branch 23 tablets HealthCare AG Jiang Wei Zhongshan Hospital, Fudan University Wang Yuqi Covance R&D (Beijing) Co., Ltd., Shanghai Branch Li Ling / / / / / / 24 Tablets Fresenius Kabi Global Liu Hongquan / / / / National Institution of Drug Clinical Trial, Aerospace Central Hospital Liu Huichen Shanghai Center for Drug Metabolism and Pharmacokinetics Research Zhong Dafang / / 25 Tablets Ranbaxy Laboratories Limited Gao Weideng / / / / Drug Clinical Trial Institution, Jilin University First Hospital Ding Yanhua Frontage Laboratories (Shanghai) Co., Ltd. Yu Qiaoling Frontage Laboratories (Shanghai) Co., Ltd. Xu Chun 26 Shenqi Xinluo Tong Tablets Wuhan Medtek Biology & Medicine Co., Ltd.; Shandong Academy Tan Yunliang, Zhang Lanying Xiyuan Hospital CACMS Tu Xiuhua / / / / / / / / 27 Probucol Tablets Otsuka Co., Ltd. Beichuan Manzhi The Second Xiangya Hospital of Central University Zhao Shuiping Rundo International Research & Development Co., Ltd. Liu Ying Clinical Pharmacology Research Center at Peking Union Medical Hu Bei Mitsubishi Chemical Medience Corporation, Clinical Pharmacology Research Center Chika Kitajima, Zhao Qian CMIC Services Co., Ltd (Beijing) Jiao Yang
37 sodium and tazobactam sodium for injection (6:1) Xiangbei Welman Co., Ltd. Sun Mingjie Shanghai Changhai Hospital, The First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Guilin Medical University Li Qiang, Yuan Weijie, Liao Yunhua, Mo Biwen, Yin Youshen Guangzhou Boji Medical Co., Ltd. Wang Yanchun National Medicine Clinical Research Base at Shaanxi Provincial People’s Hospital Lian Jiangping National Medicine Clinical Research Base at School of Stomatology, The Fourth Military Medical University Wang Xiaojuan / / 38 Amlodipine Besylate Tablets Chongqing Yaopharma Co., Ltd. Liu Qiang / / / / Drug Clinical Trial Institution of Shanghai Xuhui District Central Hospital Yu Chen Central Laboratory, Shanghai Xuhui Central Hospital Yu Chen / / 39 Docetaxel Injection Pharma S.A. (Peng Zhenke) Shanghai People’s Hospital, Shanghai JiaoTong University School of Medicine, Tumor Prevention and Treatment Center of Zhongshan University Guo Wei, Lu Taixiang / / / / / / / / 40 Docetaxel Injection Pharma S.A. Shanghai Ninth People’s Guo Wei, Lu Taixiang / / / / / / / /
Zhenke) Hospital, Shanghai JiaoTong University School of Medicine, Tumor Prevention and Treatment Center of Zhongshan University 41 Rasagiline Mesylate Tablets Lundbeck (Beijing) Consulting Co, Ltd. Herman Santoni Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Zhang Zhenxin Covance Inc (Covance) John Armstrong Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Hu Bei Clinical Pharmacology Research Center Laboratory Hu Bei Covance Clinical Research Unit Ltd (Covance) Vicky Hsu 42 Rasagiline Mesylate Tablets Lundbeck (Beijing) Consulting Co, Ltd. Herman Santoni Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Zhang Zhenxin Covance Inc(Covance) John Armstrong Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Hu Bei Clinical Pharmacology Research Center Laboratory Hu Bei Covance Clinical Research Unit Ltd (Covance) Vicky Hsu 43 Alprostadil Dried Emulsion for Injection Liaoning Sino Healthcare Bio Co., Ltd. Huang Hai Peking University Third Hospital Li Xuan Beijing Sinoyas Health Technology Development Co., Ltd. Cheng Hong / / / / / / 44 Alprostadil Liaoning Sino Huang Hai Peking University Li Xuan Beijing Sinoyas Hong / / / / / /
Emulsion for Injection Healthcare Bio Co., Ltd., Dalian Aleph Biomedical Co., Ltd. Third Hospital Health Technology Development Co., Ltd. 45 Wan Pi Xiao Capsules Changchun Yingping Co. Ltd. Wu Yingping Affiliated Hospital of Shandong University of TCM Du Xiulan / / / / / / / / 46 Clopidogrel Hydrogen Sulphate Tablets Norvatis Shanghai Trading Co., Ltd. Sheng / / / / National Drug Clinical Trial Institution, The Second Affiliated Hospital of Soochow University Zhang Quanying Clinical Pharmacological Laboratory, The Second Affiliated Hospital of Soochow University Zhang Shanghai Bestudy Medical Technology Co., Ltd. Qu Xingchi 47 Bromide Injection Fresenius Kabi Global Liu Hongquan Chinese Academy of Medical Sciences & Peking Union Medical College Hospital Huang Guangyu / / / / / / / / 48 Ibuprofen Sustained Release Suspension Yangzhou No.3 Co., Ltd. Tang Zhongxin / / / / Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine Qiu Furong Shanghai Center for Drug Metabolism and Pharmacokinetics Research Zhong Dafang, Chen Xiaoyan / / 49 Tolvaptan Tablets Zhejiang Otsuka Zhang Yi Zhang Jian EPS China Co., Ltd. Yue ChangHe / / / / / /
Co., Ltd. Hospital, Chinese Academy of Medical Sciences 50 Tolvaptan Tablets Zhejiang Otsuka Co., Ltd. Zhang Yi Fuwai Hospital, Chinese Academy of Medical Sciences Zhang Jian EPS Co., Ltd. Yue ChangHe / / / / / /