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address: 28, Gaopeng Road, New and Hi-tech Development Zone, Chengdu

SiChuan Province,

P.R.China,
contact: Tel: +86-28-85172409
Fax: +86-28-85173043
key person: Director: Li Wang

Deputy director:
Hongxia Li, Xiabo Cen

Key consultant:
Li zhan, Bichun Liu, Yinglan Zhao,
Yuqing Liu, Yasi Yang, Chaojun Wang,
Maozhi Liang, Yongpin Qin, Yanqiang Zhuo

trunover in millions USD: 0
R & D turnover in millions USD: 0
NET profit: 0
year of financial results: 0
employees: 34

active in China: YES

SFDA approved: YES
SFDA approved date: 30/11/2004
SFDA approved Chinese laboratories: National Chengdu Center for Safety Evaluation
Address & Contact Details: Project service (project consultation or project cooperation):

Associate Prof. Hongxia Li

Tel: +86-28-85172409

Fax: +86-28-85173043

Address: 28, Gaopeng Road, New and Hi-tech Development Zone
key personnel: Director: Li Wang

Deputy director:
Hongxia Li, Xiabo Cen

Key consultant:
Li zhan, Bichun Liu, Yinglan Zhao,
Yuqing Liu, Yasi Yang, Chaojun Wang,
Maozhi Liang, Yongpin Qin, Yanqiang Zhuo

Approvals:
GLP: YES
GMP: NO
AAALAC: NO
SEPA: NO

Activities engaged in:
Manufacture: NO
Active Pharmaceutical: YES
R&D: YES
Ingredients: YES
Western Generics: NO
TCM: YES

R & D:
Discovery: YES
Work Up (pilot to production): YES
Analysis: YES
Quality Control: YES
Stability: YES
Batch Release: YES

Clinical trials:
Run/Manage: NO
Data management: NO
Support Labs: NO

Non clinical & preclinical:
Animal Testing: GLP: YES
New materials Safety Assessment: YES
Pharmaceuticals: YES
Agrochemicals: NO
Industrial & Other Chemicals: YES
Non GLP - Discovery ADME: YES

Chemistry-contract manufacture:
Generics: NO
API: NO
Licensed Drugs: NO

test:
R&D: NO
 
National Chengdu Center for Safety Evaluation of Drugs (Traditional Chinese Medicine) was approved to establish in Feb.2000 by the Ministry of Sciences & Technology of China. West China Hospital , Sichuan University was the main investor and leaded the construction of the center. It is one of the national key centers for toxicity and pharmacology studies of drugs including Traditional Chinese Medicine, Natural Herb, Biotechnology-derived Pharmaceuticals, Chemicals and other health related products.  Principles of Good Laboratory Practice apply to all non-clinical safety studies required by regulations for the purpose of register in this test facility.
 
The center, located in the New and Hi-tech Development Zone of Chengdu with construction area of 7800 square meters , was designed by a professional Japanese design company according to international standard. It possesses an experimental building , a SPF animal facility and a conventional animal facility.
 
The center has a qualified team with more than 30 professionals working on Toxicology and Pharmacology´╝îwho have rich theory level and practice experience and can conduct pre-clinical studies with high quality and high efficiency. Their major cover pharmacology, toxicology, analytical chemistry, pathology, clinical examination, traditional Chinese medicine, statistics, informatics et al. The main power of the team is composed of three Postdoc, four personnel with Ph.D , six with M.S , most of them have the experience of studying aboard.

 
Professional education is also another function of the center. There is one national Class 1 doctoral research station—clinic drug and apparatus evaluation science, and one doctor mentor and three master mentors. There are now 2 MD candidates and 10 master candidates major in clinic drug and apparatus evaluation science.
 
The center has already established postdoctoral scientific research station which can recruit graduate student for postdoctor in corporation of New&High-tech development zone,chengdu.Right now there are 3 postdoctors working in it.

 
There are 10 divisions including dept. of toxicology, pathology, pharmacology, laboratory animal, clinic examination, test articles, archive ,general management, QAU, and IT center.
 
Single dose toxicity study(rat, mouse, rabbit, dog and monkey), repeated dose toxicity study(rat, rabbit, dog and monkey), reproductive and development toxicity study, genotoxicity study, carcinogenicity study, allergic study, local irritation study, immunogenicity study, safety pharmacology study, pharmacokinetic/toxicokinetic study are performed under the rules of GLP and requirement for pharmaceuticals register from SFDA. Meanwhile pharmacodynamical studies can also be carried out in the center such as Cardiovascular system drugs, Anticancer drugs, Central nervous system drugs, Endocrine system drugs, Digestive system drugs, Respiration system drugs, Urinary system drugs, Blood system drugs, Anti-virus drugs, and Biotechnology-derived pharmaceuticals such as gene engineering protein, gene therapy drugs, antibody and vaccine as well as natural herb.
 
The center has achieved a lot in international technology exchange and cooperation. Since its run in Nov.2002, the center has signed couples of project cooperation agreement with domestic institutes and enterprises, Hong Kong Baptist University, The Hong Kong Polytechnic University, Macao Chinese Medicine and Biotechnic Institute, Korea Company, American Company etc.
 
The center passed the GLP authentication hold by the State Food and Drug Administration (SFDA) of the People's Republic of China in Nov.2004 and became one of the first domestic centers  which  passed the GLP authentication.
 

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