中国临床药理学杂志2011,Vol.27Issue(9):718-721,4.
中日两国药物临床试验管理规范及其检查制度的比较
Comparison of good clinical practice and its inspection system between China and Japan
摘要
Abstract
To accelerate good clinical practice (GCP) implementation in China, and improve the competitiveness of China in international clinical trial area, we should use the experience of developed countries for reference. Introduced the GCP implementation, legal basis, inspection system and training in Japan, compared with China's situation, and made a conclusion of the useful points. China and Japan have a lot of similarities in GCP regulation and inspection system, and also have their own advantages and characteristics.关键词
药物临床试验管理规范/检查/比较Key words
good clinical practice/ inspection/ comparison分类
医药卫生引用本文复制引用
王佳楠..中日两国药物临床试验管理规范及其检查制度的比较[J].中国临床药理学杂志,2011,27(9):718-721,4.基金项目
国家十一五科技重大专项基金资助项目(2009ZX09309-003) (2009ZX09309-003)