中国药物GLP机构发展和运行现状

目的了解国家食品药品监督管理局(SFDA)药品非临床研究质量管理规范(GLP)认证的研究机构发展和运行现状。方法通过网络进行在线问卷调查,汇总全国各药物GLP机构有关设施规模、人员和培训情况等详细信息,进行统计分析。结果有38家通过SFDA GLP认证的机构提供了有效信息。90%左右的机构动物房面积在500 m2以上;各机构本科以上从业人员在1600名以上,一半以上机构硕士人员占到30%;30家机构建立了动物福利制度;28家机构完成了重要检测设备的3Q确认程序;7家机构通过了中国合格评定国家认可委员会(CNAS)的ISO17025实验室认可。结论中国非临床安全性评价机构的GLP运行管理水平建设正处于上升发展阶段,在人员结构、动物管理、仪器设备和软件化管理等方面正在向国际水平靠拢。

A survey report for developing and operating situation of GLP facilities in China

Objective To investigate the nonclinical research facilities certified by SFDA,so as to know the developing and operating situation of GLP facilities.Methods To do the questionnaire survey on the Internet,this survey collected the detail information about the scale of the instrument of GLP facilities in China,staff and training situation,etc.and use SPSS to analyse the information.Results Thirty-eight SFDA-certified facilities provided valid information.The result of the survey shows that animal room’s area of 90% facilities are above 500 m2;the number of staffs who have the bachelor degree is above 1600,the 30% staffs in half of facilities have master degree;30 facilities established animal welfare system;28 facilities completed the 3Q confirmed program of important monitoring instruments;7 facilities passed the CNAS ISO17025 of laboratory accreditation.Conclusion The operating and management standard of the nonclinical facilities are on the rapid developing stage,and that is close to the international standard on the side of personnel structure,animal management,instrument,software application and etc.