论文部分内容阅读
《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。
GLP plays an important role in preclinical drug research and is an important link in the drug development process. Relevant work on GLP in China started in the late 1990s. After nearly 20 years of rapid development, China has completed the initial construction of the GLP system. This article first reviews the basic situation of GLP institutions in this field, introduces the changes of the annual growth rate and total number of GLP institutions in China, the existing types of GLP institutions and their specific service capabilities, and then selects “Eleventh Five-Year”, “ During the 12th Five-Year Plan ”, some institutions supported by major projects of new drugs were mainly introduced. Although GLP institutions in China have made significant progress in the construction of hardware and software, some problems still remain. For example, there is not enough innovation capacity, so the construction of GLP in our country still needs to be further perfected and developed.