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Catalogue of On-site Inspection Varieties for the Drug Clinical Trial Data
S.N
.
Pendin
g
Numbe
r
Drug
Name
Applicatio
n Unit
Responsibl
e Person of
Applicatio
n Unit
Clinical
Trial
Group
Leader
Unit
Principal
Investigat
or
Contract
Research
Organizatio
n
Responsib
le Person
of
Contract
Research
Organizat
ion
Institution of
Phase I/BE
Clinical Trial
Principal
Investigato
r of Phase
I/BE
Phase I /BE
Analytical
Testing Unit
Principa
l
Investig
ator of
Phase
I /BE
Analytic
al
Testing
Principal
Investigator
f Phase I
/BE
Phase
I /BE
Responsi
ble
Person of
Contract
Research
Organiza
tion
1CYHS1
390057
Tenofovir
Disoproxil
Fumarate
Tablets
Qilu
Pharmaceut
ical 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 JXHS1
300104
Concentrat
ed
Levetiracet
am
Solution
for
UCB
Trading
(Shanghai)
Co., Ltd.
Veronique
Toully
/ / / / Drug Clinical
Trial
Institution of
Shanghai
Xuhui District
Central
Liu Yun Frontage
Laboratories
(Shanghai) Co.,
Ltd.
Zuo
Ming
PAREXEL
Internal
GmbH
Huang
Manli
Injection Hospital
3JXSS1
400006
Adalimum
ab Solution
for
Injection
AbbVie LtdTony (Ou
Silang)
Peking
University
People’s
Hospital
=Zhang
Jianzhong/ / / / / / / /
4JYSB1
400221
Insulin
Glargine
Injection
Sanofi-
Aventis
Deutschlan
d
GmbH;San
ofi-
AventisDeu
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
Hospital,
Beijing
Children’s
Hospital,
Capital
Medical
University
Chen
Xiaobo,
Zhao
Weigang,
Gong
Chunxiu
Q2 Solutions
(Beijing)
Pharmaceutical
R&D Co., Ltd.
/ / /
5 JYSB1
400222
Insulin
Glargine
Injection
Sanofi-
Aventis
Deutschlan
d
Gao
Lingyun
(Peter
Guenter)
Beijing
Children’s
Hospital,
Capital
Gong
Chunxiu
/ / Children's
Hospital
Affiliated to
Capital
Chen
Xiaobo,
Zhao
Weigang,
Q2 Solutions
(Beijing)
Pharmaceutical
R&D Co., Ltd.
/ / /
GmbH;San
ofi-
AventisDeu
Medical
University
Institute of
Pediatrics,
Peking Union
Medical
College
Hospital,
Beijing
Children’s
Hospital,
Capital
Medical
University
Gong
Chunxiu
6 CXHS1
400149
Nevirapine
,
Zidovudin
e and
Lamivudin
e Tablets
Shanghai
Desano
Bio-
Pharmaceut
ical Co.,
Ltd.
An Xiaoxia / / / / National Drug
Clinical Trial
Institution,
Shuguang
Hospital
Affiliated to
Shanghai
University of
Traditional
Chinese
Medicine,
National Drug
Clinical Trial
Qiu Furong,
Sun
Yinghao
National Drug
Clinical Trial
Institution,
Guangzhou
Huiai Hospital,
Shanghai
Modern
Pharmaceutical
Co.,
Ltd.,Celerion
Inc.
Wen
Yuguan,
Ma Cui,
Ge
Qinghua,
Peggy
Ruhn
/ /
Institution,
Shanghai
Changhai
Hospital
7JXHS1
600016
Sugammad
ex
Injection
MSD R&D
(China)
Co., Ltd.
Li
Zhengqing
Peking
University
First
Hospital,
Ruijin
Hospital,
Shanghai
Jiaotong
University
School of
Medicine
Wu
Xinmin,
Yu Buwei
/ /
Zhongshan
Hospital,
Fudan
University
Li XueningQUINTILES
B.V.
Elsa
Artola/ /
8 JXHS1
600017
Sugammad
ex
Injection
MSD R&D
(China)
Co., Ltd.
Li
Zhengqing
Peking
University
First
Hospital,
Ruijin
Hospital,
Shanghai
Jiaotong
University
School of
Wu
Xinmin,
Yu Buwei
/ / Zhongshan
Hospital,
Fudan
University
Li Xuening QUINTILES
B.V.
Elsa
Artola
/ /
Medicine
9JXHS1
600040
Sorafenib
Tosylate
Tablets
Bayer
HealthCare
AG
Jiang Wei
Affiliated
Cancer
Hospital ,
Tianjin
Medical
University
Shi
Yuankai
APEX China
Co., Ltd.Mu Nan / / / / / /
10JXHS1
600039
Vemurafen
ib tablets
Roche
Pharma(Sch
weiz)
AG;Roche
S.p.A. ;Sha
nghai
Roche
Pharmaceut
ical 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/ /
11CXHS1
600006
Albuvirtid
e for
injection
Nanjing
Frontier
Biotechnolo
gies
DONG XIE
Beijing
Youan
Hospital,
Capital
Medical
University
Wu Hao
Beijing
Konted
Medical
Technology
Co., Ltd.
Zhang
Ting
Beijing
Youan
Hospital,
Capital
Medical
University
Wu Hao
Biological
Sample Analysis
Laboratory,
Beijing Youan
Hospital
Jin
Ronghua
Beijing
Konted
Medical
Technology
Co., Ltd.
Zhang
Ting
12 JXSS1
400003
Etanercept
injection
Pfizer
Limited
Wu
Xiaobin
/ / / / Peking
University
Lv Yuan Celerion, Inc. Peggy
Ruhn,
/ /
First Hospital Ph.D
13JXSS1
400004
Etanercept
injection
Pfizer
Limited
Wu
Xiaobin/ / / /
Peking
University
First Hospital
Lv Yuan Celerion, Inc.
Peggy
Ruhn,
Ph.D.
/ /
14JXSS1
400005
Omalizum
ab
Injection
Novartis
Europharm
Limited
Ma Tao
First
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 CYSS1
400001
Hepatitis B
virus/hepat
itis 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 Blood
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
Control、Central
Blood Station of
Xiamen, Henan
Red Cross Blood
Center, Central
Wei
Guolan,
Ge
Hongwei
, Xu
Sihong,
Ou
Shanhai,
Fang
Jianhua,
Yang
Sisi
/ /
Blood Station of
Qingdao
16JXHS1
300099
Saxagliptin
+
Metformin
Extended-
release
tablets (I)
AstraZenec
a ABWang Lei / / / /
Peking
University
Third
Hospital
Li Haiyan
Bioanalytical
Service
Department,
Wuxi Apptec
New Drug
Development
Co., Ltd.
Shanghai
Chen
Weikao/ /
17JXHS1
300100
Saxagliptin
+
Metformin
Extended-
release
tablets (II)
AstraZenec
a ABWang Lei / / / /
Peking
University
Third
Hospital
Li Haiyan
Bioanalytical
Service
Department,
Wuxi Apptec
New Drug
Development
Co., Ltd.
Shanghai
Chen
Weikao/ /
18JXHS1
400131
Linagliptin
+
Metformin
tablets (Ⅰ)
Boehringer
Ingelheim
(China)
Investment
Co., Ltd.
David
Preston,
Chen
Xiaoxiang
Shanghai
Ruijin
Hospital
Ning
Guang
Theorem
(Shanghai)M
edical
Technology
Consulting
Co.,Ltd.
You
Jianguo
Peking
University
First Hospital
Cui Yimin
SGS CEPHAC
EUROPE
S.A.S./Covance
Laboratories
Limited
Covance
:
Geneviè
ve
Branger;
SGS: E
Ferguson
ICON
Clinical
Research
Limited
Zhang
Xiaokang
19JXHS1
400133
Linagliptin
+
Metformin
tablets (Ⅱ)
Boehringer
Ingelheim
(China)
Investment
Co., Ltd.
David
Preston,
Chen
Xiaoxiang
Shanghai
Ruijin
Hospital
Ning
Guang
Theorem
(Shanghai)M
edical
Technology
Consulting
Co.,Ltd.
You
Jianguo
Peking
University
First Hospital
Cui Yimin
SGS CEPHAC
EUROPE
S.A.S./Covance
Laboratories
Limited
Covance
:
Geneviè
ve
Branger;
SGS: E
Ferguson
ICON
Clinical
Research
Limited
Zhang
Xiaokang
20JXHS1
600028
Rivaroxab
an tablets
Bayer
HealthCare
AG
Jiang Wei
Zhongshan
Hospital,
Fudan
University
Wang
Yuqi
Covance
Pharmaceuti
cal R&D
(Beijing)
Co., Ltd.,
Shanghai
Branch
Li Ling / / / / / /
21JXHS1
600029
Rivaroxab
an tablets
Bayer
HealthCare
AG
Jiang Wei
Zhongshan
Hospital,
Fudan
University
Wang
Yuqi
Covance
Pharmaceuti
cal R&D
(Beijing)
Co., Ltd.,
Shanghai
Branch
Li Ling / / / / / /
22 JXHS1
600031
Rivaroxab
an tablets
Bayer
HealthCare
AG
Jiang Wei Zhongshan
Hospital,
Fudan
University
Wang
Yuqi
Covance
Pharmaceuti
cal R&D
(Beijing)
Li Ling / / / / / /
Co., Ltd.,
Shanghai
Branch
23JXHS1
600032
Rivaroxab
an tablets
Bayer
HealthCare
AG
Jiang Wei
Zhongshan
Hospital,
Fudan
University
Wang
Yuqi
Covance
Pharmaceuti
cal R&D
(Beijing)
Co., Ltd.,
Shanghai
Branch
Li Ling / / / / / /
24JXHS1
300040
Bicalutami
de Tablets
Fresenius
Kabi Global
Liu
Hongquan/ / / /
National
Institution of
Drug Clinical
Trial,
Aerospace
Central
Hospital
Liu Huichen
Shanghai Center
for Drug
Metabolism and
Pharmacokinetic
s Research
Zhong
Dafang/ /
25JXHS1
300046
Lamivudin
e Tablets
Ranbaxy
Laboratorie
s 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 CXZR1
300011
Shenqi
Xinluo
Wuhan
Medtek
Tan
Yunliang,
Xiyuan
Hospital
Tu
Xiuhua
/ / / / / / / /
Tong
Tablets
Biology &
Medicine
Co., Ltd.;
Shandong
Biopharmac
eutical
Academy
Zhang
LanyingCACMS
27JXHS1
300052
Probucol
Tablets
Otsuka
Pharmaceut
ical Co.,
Ltd.
Beichuan
Manzhi
The Second
Xiangya
Hospital of
Central
South
University
Zhao
Shuiping
Rundo
International
Pharmaceuti
cal Research
&
Development
Co., Ltd.
Liu Ying
Clinical
Pharmacology
Research
Center at
Peking Union
Medical
College
Hospital
Hu Bei
Mitsubishi
Chemical
Medience
Corporation,
Clinical
Pharmacology
Research Center
at Union Medical
College Hospital
Chika
Kitajima
, Zhao
Qian
CMIC
Pharmaceuti
cal Services
Co., Ltd
(Beijing)
Jiao Yang
28CYHS1
390043
Clopidogre
l Hydrogen
Sulphate
Tablets
Jiangsu
Hengrui
Medicine
Co., Ltd.
Sun
Piaoyang/ / / /
The First
Hospital of
Lanzhou
University
Wang Ting
Shanghai Center
for Drug
Metabolism and
Pharmacokinetic
s Research
Zhong
Dafang,
Chen
Xiaoyan
/ /
29 JXHS1
300062
Acarbose
Tablets
Shanghai
Longde
Medical
Technology
Lu Qin
Maximilian
/ / / / Hospital of
Dermatology,
Chinese
Academy of
Ma
Pengcheng
China
Pharmaceutical
University
Yang Jin / /
Co., Ltd.Medical
Sciences
30CXZS1
300008
Jinrong
Xiaopi
Gradules
Guangzhou
Kangyuan
Pharmaceut
ical Co.,
Ltd.
Liang
Jiaxing,
Zhou
Ruopeng,
Li
Wenquan
Jiangsu
Province
Hospital of
TCM
Bian
Weihe/ / / / / / / /
31CYHS1
390051
Oxycodon
e
Acetamino
phen
Capsules
Hebei
Aoxing
Group
Pharmaceut
ical Co.,
Ltd.
Yue Yifa / / / /
National Drug
Clinical Trial
Institution,
General
Hospital of
Chengdu
Military Area
Xu Guili
Phase I Clinical
Trial Research
Laboratory,
General Hospital
of Chengdu
Military Area
He
Jianchan
g
/ /
32CYHS1
390052
Oxycodon
e
Acetamino
phen
tablets
Hebei
Aoxing
Group
Pharmaceut
ical Co.,
Ltd.
Yue Yifa / / / /
National Drug
Clinical Trial
Institution,
General
Hospital of
Chengdu
Military Area
Xu Guili
Phase I Clinical
Trial Research
Laboratory,
General Hospital
of Chengdu
Military Area
He
Jianchan
g
/ /
33 JXHS1
300089
Cefbupera
zone
Sodium
Hanaro
Biopharmac
eutical Co.,
Sung-Wuk
Kim
Chinese
PLA
General
Chen
Liangan
GCP
ClinPlus Co.,
Ltd.
Zhang
Shanshan
National Drug
Clinical Trial
Institution,
Wang Rui,
Liang
Beibei
Phase I Clinical
Trial Laboratory,
Chinese PLA
Wang
Rui,
Liang
GCP
ClinPlus Co.,
Ltd.
Tian Ye
Injection Ltd. Hospital
Chinese PLA
General
Hospital,
Clinical
Pharmacology
Laboratory,
Chinese PLA
General
Hospital
General Hospital Beibei
34JXHS1
300094
Mometaso
ne Furoate
Aqueous
Nasal
Spray
MSD R&D
(China)
Co., Ltd.
Li
Zhengqing
Beijing
Tongren
Hospital
Affiliated to
Capital
Medical
University
Han
Demin/ / / / / / / /
35 CXHS1
300286
Cefoperaz
one
sodium
and
tazobactam
sodium for
injection
(6:1)
Xiangbei
Welman
Pharmaceut
ical Co.,
Ltd.
Sun
Mingjie
Shanghai
Changhai
Hospital,
The First
Affiliated
Hospital of
Guangxi
Medical
University,
Li Qiang,
Yuan
Weijie,
Liao
Yunhua,
Mo
Biwen,
Yin
Yousheng
Guangzhou
Boji Medical
Biotechnolog
ical 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
/ /
Affiliated
Hospital of
Guilin
Medical
University
36CXHS1
300287
Cefoperaz
one
sodium
and
tazobactam
sodium for
injection
(6:1)
Xiangbei
Welman
Pharmaceut
ical 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
Yousheng
Guangzhou
Boji Medical
Biotechnolog
ical 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/ /
37 CXHS1
300288
Cefoperaz
one
sodium
and
tazobactam
sodium for
Xiangbei
Welman
Pharmaceut
ical Co.,
Ltd.
Sun
Mingjie
Shanghai
Changhai
Hospital,
The First
Affiliated
Hospital of
Li Qiang,
Yuan
Weijie,
Liao
Yunhua,
Mo
Guangzhou
Boji Medical
Biotechnolog
ical Co., Ltd.
Wang
Yanchun
National
Medicine
Clinical
Research
Base at
Shaanxi
Lian
Jiangping
National
Medicine
Clinical
Research Base at
School of
Stomatology,
Wang
Xiaojuan
/ /
injection
(6:1)
Guangxi
Medical
University,
Affiliated
Hospital of
Guilin
Medical
University
Biwen,
Yin
Youshen
Provincial
People’s
Hospital
The Fourth
Military Medical
University
38CYHS1
390088
Amlodipin
e Besylate
Tablets
Chongqing
Yaopharma
Pharmaceut
ical 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 JXHS1
300109
Docetaxel
Injection
Aventis
Pharma
S.A.
Jean-
christopheP
ointeau
(Peng
Zhenke)
Shanghai
Ninth
People’s
Hospital,
Shanghai
JiaoTong
University
School of
Medicine,
Tumor
Guo Wei,
Lu
Taixiang
/ / / / / / / /
Prevention
and
Treatment
Center of
Zhongshan
University
40JXHS1
300110
Docetaxel
Injection
Aventis
Pharma
S.A.
Jean-
christopheP
ointeau(Pen
g Zhenke)
Shanghai
Ninth
People’s
Hospital,
Shanghai
JiaoTong
University
School of
Medicine,
Tumor
Prevention
and
Treatment
Center of
Zhongshan
University
Guo Wei,
Lu
Taixiang
/ / / / / / / /
41 JXHS1
300114
Rasagiline
Mesylate
Tablets
Lundbeck
(Beijing)
Pharmaceut
SørenKjeld
Kristensen,
Herman
Chinese
Academy of
Medical
Zhang
Zhenxin
Covance Inc
(Covance)
John
Armstrong
Chinese
Academy of
Medical
Hu Bei Clinical
Pharmacology
Research Center
Hu Bei Covance
Clinical
Research
Vicky
Hsu
ical
Consulting
Co, Ltd.
Santoni
Sciences &
Peking
Union
Medical
College
Hospital
Sciences &
Peking Union
Medical
College
Hospital
LaboratoryUnit Ltd
(Covance)
42JXHS1
300115
Rasagiline
Mesylate
Tablets
Lundbeck
(Beijing)
Pharmaceut
ical
Consulting
Co, Ltd.
SørenKjeld
Kristensen,
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
43CXHS1
300192
Alprostadil
Dried
Emulsion
for
Injection
Liaoning
Sino
Healthcare
Bio
Pharmaceut
ical Co.,
Ltd.
Huang Hai
Peking
University
Third
Hospital
Li Xuan
Beijing
Sinoyas
Health
Technology
Development
Co., Ltd.
Cheng
Hong/ / / / / /
44 CXHS1
300193
Alprostadil
Dried
Emulsion
Liaoning
Sino
Healthcare
Huang Hai Peking
University
Third
Li Xuan Beijing
Sinoyas
Health
Cheng
Hong
/ / / / / /
for
Injection
Bio
Pharmaceut
ical Co.,
Ltd.,
Dalian
Aleph
Biomedical
Co., Ltd.
Hospital
Technology
Development
Co., Ltd.
45CXZS1
300013
Wan Pi
Xiao
Capsules
Changchun
Yingping
Pharmaceut
ical Co.
Ltd.
Wu
Yingping
Affiliated
Hospital of
Shandong
University
of TCM
Du Xiulan / / / / / / / /
46JXHS1
400007
Clopidogre
l Hydrogen
Sulphate
Tablets
Norvatis
Shanghai
Trading
Co., Ltd.
Zhong
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
Quanyin
g
Shanghai
Bestudy
Medical
Technology
Co., Ltd.
Qu
Xingchi
47 JXHS1
400005
Rocuroniu
m Bromide
Injection
Fresenius
Kabi Global
Liu
Hongquan
Chinese
Academy of
Medical
Sciences &
Huang
Guangyu
/ / / / / / / /
Peking
Union
Medical
College
Hospital
48CYHS1
490018
Ibuprofen
Sustained
Release
Suspension
Yangzhou
No.3
Pharmaceut
ical Co.,
Ltd.
Tang
Zhongxin/ / / /
Shuguang
Hospital
affiliated to
Shanghai
University of
Traditional
Chinese
Medicine
Qiu Furong
Shanghai Center
for Drug
Metabolism and
Pharmacokinetic
s Research
Zhong
Dafang,
Chen
Xiaoyan
/ /
49CXHS1
400061
Tolvaptan
Tablets
Zhejiang
Otsuka
Pharmaceut
ical Co.,
Ltd.
Zhang Yi
Fuwai
Cardiovascu
lar Hospital,
Chinese
Academy of
Medical
Sciences
Zhang
Jian
EPS China
Co., Ltd.
Yue
ChangHe/ / / / / /
50 CXHS1
400062
Tolvaptan
Tablets
Zhejiang
Otsuka
Pharmaceut
ical Co.,
Ltd.
Zhang Yi Fuwai
Cardiovascu
lar Hospital,
Chinese
Academy of
Zhang
Jian
EPS China
Co., Ltd.
Yue
ChangHe
/ / / / / /
Medical
Sciences
