实验病理学在药品监管中的建设与发展初探  

Primary study on the construction and development of experimental pathology in medical supervision

作　　者：金毅 巢琳琳 金志虎 甘玉玺 臧德跃 曹生田 冯珊珊 邓俊成 林柏佑 黄后双 薛有安 王汝仙 谢泳娇 谢天柱 陈润桦 孙晓 李静 JIN Yi;CHAO Lin-lin;JIN Zhi-hu;GAN Yu-xi;ZANG De-yue;CAO Sheng-tian;FENG Shan-shan;DENG Jun-cheng;LIN Bai-you;HUANG Hou-shuang;XUE You-an;WANG Ru-xian;XIE Yong-jiao;XIE Tian-zhu;CHEN Run-hua;SUN Xiao;LI Jing(Shenzhen Institute far Drug Control(Shenzhen Testing Center of Medical Devices),Project of the Key Laboratory of Experimental Pathology,Guangdong Medical Products Administration,Shenzhen 518057,China;Shenzhen Jinzhi Technology Co.,Ltd.,Shenzhen 518133,China;Sunshine Lake Pharma Limited Liability Company,Dongguan 523859,China)

机构地区：[1]深圳市药品检验研究院(深圳市医疗器械检测中心)广东省药监局实验病理学重点实验室,深圳518057 [2]深圳金质科技有限公司,深圳518133 [3]广东东阳光药业有限公司,东莞523859

出　　处：《中国新药杂志》2022年第5期417-421,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项:非酒精性脂肪性肝炎及器官纤维化疾病创新药物的临床研究与开发(2018ZX09201002);抗感染新药研发国家重点实验室项目(2015DQ780357);广东省药品监督管理局实验病理学重点实验室项目(2020ZDB11)。

摘　　要：通过分析我国实验病理学在药品监管中的历史、背景和局限性,初步探索了实验病理学在药品监管中的发展、地位和作用,阐述了为适应当代全程药品监管和全生命周期医药研发的新理念,需要提升实验病理学的学科定位和作用,更广泛深入到医药研发的多个关键环节。在实验病理学建设和发展的实践方面,自2014年至今坚持开展多方位的学术交流与培训,特别是近3年举办了约80场次对全国专业人员开放的实验病理学公益网络学习会,使我国实验病理学在互联网+公益培训的先进理念和实践上已走在世界前列。2020年广东省药品监督管理局批准建设实验病理学重点实验室及深圳市专家人才联合会、成立实验病理学专业委员会,对提升专业人员水平、加强实验病理学在药品监管中的作用做了一些探索和努力。Based on the analysis on the history,background and limitations of experimental pathology in the medical supervision in China,this paper further observes the development,status and role.It also elaborates the new principle satisfying the supervision of the entire medical and pharmaceutical research in whole life cycle.The discipline orientation and function of experimental pathology needs to be improved and reinforced in multiple aspects of drug research and development.On the aspects of construction and development of experimental pathology,multidimensional practice of academic communication and training has been carried out since 2014,especially approximately 80 times of online conferences open to national professionals in nearly three years,making China lead the world in the advanced principle and practice of internet public training on experimental pathology.The Key Laboratory of Experimental Pathology was approved by Guangdong Provincial Medical Products Administration,and Professional Committee of Experimental Pathology was established by Shenzhen Experts United Association in 2020,all of which were the exploration attempt made in the study of the effect of experimental pathology in medicine supervision.

关 键 词：实验病理学 药品监管 全生命周期 毒性病理学 药效病理学 

分 类 号：R95[医药卫生—药学]