中国与韩国药物非临床研究质量管理规范的比较

Comparison of Good Labovatory praetice between China and Korea

目的:寻找中国与韩国药物非临床研究质量管理规范(GLP)的共同点和差异,比较各方GLP的优势,提出发展和完善我国GLP的建议。方法:采用文献法及比较法,结合我国GLP现状,详细分析两国GLP的内容和发展现状。结果:两国GLP整体内容基本一致,特别在实验设施及仪器管理、供试品及对照物、标准操作规程等方面相差不大,但在管理体系、定义及解析、组织机构和人员、工作人员理念及GLP认证检查等方面有差异。结论:我国GLP机构有必要导入毒性试验管理软件及多地点试验概念,并需要加强动物伦理及保护方面的措施。

Aim： To find the common points and differences of the good laboratory practice （GLP） between China and Korea,and to compare the advantages of each GLP,the suggestions to develop and perfect the GLP in China were raised.Methods：This study uses literature and comparison method,and the present developmental situation of GLP between two countries were analyzed in detail combined with the current situation of GLP in China.Results：GLP issued by SFDA and KFDA were basically consistent in general structure and topics,especially in the aspect of lab facility,equipment management,SOP,test and control articles.However,some differences were existed with regard to management system,definition and analysis,organization and personnel,testing protocol,report and GLP inspection.Conclusion：It is necessary to introduce the management software of toxic studies and the concept of multi-site studies for institution of GLP in China,and to strengthen the measures in the aspect of animal rights and animal welfare.