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简介

中国药品生物制品检定所，

国家药物安全评价监测中心

  国家药物安全评价监测中心位于北京经济技术开发区宏达中路甲8号。总占地面积：7104.9㎡,建筑设施面积：5640㎡,实验区域总面积：4028.16㎡。其中：啮齿类动物实验研究相关区域1622.16平方米, 大动物房（猴、狗）建筑面积1350平方米，其他实验研究相关区域1417.14平方米。

国家药物安全评价监测中心隶属于国家食品药品监督管理局中国药品生物制品检定所。主要从事药物非临床研究中的安全性评价工作。中心配备完备的实验动物实验设施和大量先进的药物安全性评价专用仪器，拥有一支具有很高专业素质和实践经验的专业技术队伍。设置有中心办公室、质量保证室（QAU）、毒性病理研究室、一般毒理研究室、遗传毒理研究室、生殖发育毒理研究室、药代（毒代）研究室、样品分析研究室、临床生化分析室、动物管理室、档案管理室、条件室。

中心在建设过程中，先后得到国家卫生部、国家科技部“863”项目、国家食品药品监督管理局、日本政府JICA项目支持。

2003年5月得到国家食品药品监督管理局的GLP认可。可对国内、外承接以下实验项目：
1．单次、多次给药毒性试验（啮齿类、非啮齿类）；
2．生殖毒性试验；
3．遗传毒性试验；
4．致癌试验；
5．局部毒性试验；
6．免疫原性试验；
7．安全性药理试验；
8．毒代动力学试验。

国家药物安全评价监测中心：

电话：010-67872233转8201

传真：010-67876255

地址：北京经济技术开发区宏达中路甲8号 

我们已经获得了AAALAC的完全认证

Introduction

National Center for Safety Evaluation of Drugs(NCSED)

The NCSED is located in Hong Da Zhong Lu A8 of Beijing Economic-Technological Development Area. It has a total area of 7104.9 square meters (m²), a building area of 5640 m², a total laboratory area of 4028.16 m², in which the laboratory area for rodents is 1622.16 m², the laboratory area for larger animals (such as monkey, dog) is 1350 m², and other related laboratory research area is 1417.14 m².

The NCSED is attached to the National Institute for the Control of Pharmaceutical and Biological Products, the State Food and Drug Administration (SFDA) of the People's Republic of China. Its main business is the safety evaluation in the non-clinical study of drugs. The center is well provided with facilities of laboratory animals, a lot of special equipments in advance for drug safety evaluation and a well-trained personnel both technically and empirically. The departments in the center include: Administration Office, Quality Assurance Unit, Toxicological Pathology Department, General Toxicity Department, Genotoxicity Department, Reproductive and Developmental Toxicity Department, Pharmacokinetics (Toxicokinetics) Department, Test Article Analysis Department, Clinical Biochemistry Department, Animal Care Department, Archive Administration Department and Maintenance  Office, and IT center.

The NCSED has been supported by the Ministry of health, the “863”project of Ministry of Science and technology, SFDA and the “JICA” project of Japan government during its construction.The NCSED was inspected for GLP compliance and approved as GLP national center by SFDA in May, 2003.

The center can carry out the studies as following:

1. Single and repeated dose Toxicity Study (in rodent / in non-rodent)

2. Reproductive and Developmental toxicity Study

3. Genotoxicity Study

4. Carcinogenicity Study

5. Local Toxicity Study

6. Immunogenecity Study

7. Safety Pharmacology Study

8. Toxicokinetic Study

National Center for Safety Evaluation of Drug (NCSED):

Tel: 86-10-67872233 ext 8201

Fax: 86-10-67876255

Address: A8 Hong Da Zhong Lu, Beijing Economic-Technological Development Area, Beijing, 100176, P.R.China

Our Institute Animal Care and Use Program is full Accredited by AAALAC since March, 2008.