瑞士GLP法令与中国GLP规范的主要差异

Major Differences between Swiss GLP Articles and Chinese GLP

本文通过对我国于2003年颁布的《药物非临床研究质量管理规范》和瑞士于2005年参照经济合作与发展组织(OECD)1998年版优良实验室规范(GLP)原则修订的《优良实验室规范法令》进行比较,重点阐明两者在人员职责、质量保证(QA)工作和档案管理方面存在的主要差异。

In this article, the Good Laboratory Practice for Non-clinical Studies of Drugs issued by SFDA in 2003 was compared with the Ordinance on Good Laboratory Practice of Switzerland which came into force in 2005 based on the revised OECD Principles of GLP, which was published in 1998, so as to clarify the differences in the issues of personal responsibility, QA program, and archiving.