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中国药学(英文版) ›› 2017, Vol. 26 ›› Issue (7): 534-544.DOI: 10.5246/jcps.2017.07.060

• 【药事管理与临床药学专栏】 • 上一篇    

中国药品非临床研究质量管理规范发展情况的回顾与展望

张靖1,2, 范潇予1, 靳洪涛1*, 耿兴超3*   

  1. 1. 中国医学科学院 药物研究所, 北京 100050
    2. 国家卫生计生委 医药卫生科技发展研究中心, 北京 100044
    3. 中国食品药品检定研究院 国家药物安全评价监测中心, 北京 100176
  • 收稿日期:2017-03-20 修回日期:2017-05-18 出版日期:2017-07-28 发布日期:2017-06-05
  • 通讯作者: Tel.: +86-010-67817730; +86-010-67876255, E-mail: jinhongtao@imm.ac.cn; gengxch@nifdc.org.cn
  • 基金资助:
    National Special Project Funds (Grant No. 2012ZX09302, 2013ZX09302).

A general introduction to the development of Good Laboratory Practice in China

Jing Zhang1,2, Xiaoyu Fan1, Hongtao Jin1*, Xingchao Geng3*   

  1. 1. Institute of Medica, Chinese Academy of Medical Sciences & Pecking Union Medical College, Beijing 100050, China
    2. Development Center for Medical Science and Technology, National Health and Family Planning Commission of the People’s Republic of China, Beijing 100050, China
    3. National Center for Safety Evaluation of Drugs, National Institute for Food and Drug Control, Beijing 100176, China
  • Received:2017-03-20 Revised:2017-05-18 Online:2017-07-28 Published:2017-06-05
  • Contact: Tel.: +86-010-67817730; +86-010-67876255, E-mail: jinhongtao@imm.ac.cn; gengxch@nifdc.org.cn
  • Supported by:
    National Special Project Funds (Grant No. 2012ZX09302, 2013ZX09302).

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摘要：

《药品非临床研究质量管理规范》(GLP)在药物临床前研究中发挥重要作用,同时也是药物研发过程中的重要环节。中国有关GLP的相关工作起步于上世纪90年代末期。经历近20年的飞速发展,我国已经完成了GLP体系的初步建设工作。本文首先回顾了该领域GLP机构的基本情况,介绍了中国GLP机构的年增长数及总数的变化情况、现有GLP机构类型及其具体服务能力,而后选择“十一五”、“十二五”期间受到新药重大专项支持的部分机构进行了重点介绍。虽然我国GLP机构在硬件和软件的建设中都取得了重大进展,但仍存有一些问题,如创新能力不足,故我国GLP的建设仍需进一步完善和发展。

关键词: GLP, 国家重大新药创制科技专项, 中国

Abstract:

Good laboratory practice (GLP) plays an important role in pre-clinical studies, which are a key stage in new drug research and development (R&D). The development of GLP in China started in the late 1990s. Following 20 years of developments, GLP system has already been established in this country. This review firstly evaluated all the institutions in this field, and described the annual number and total number of institutions, the distribution of GLP institutions, the types of GLP institutions, and the service provided by these GLP institutions. Since the initiation of the National Key Technology R&D Program during the 11th Five-Year Plan, it had a significant effect on the development of GLP. Therefore, the institutions which have undertaken projects from this program will be introduced later. We also described the infrastructure of hardware and software in GLP institutions along with their faults, such as variation in development and the lack of innovation.

Key words: GLP, National Key Technology R&D Program, China

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