我国高等药学教育引入“仿制药一致性评价”的探讨  

Discussion on the Introduction of“Generic Drug Consistency Evaluation”into Chinese Higher Pharmacy Education

作　　者：邹昆[1] 尹璐 何家林 陈萨 程强[1] ZOU Kun;YIN Lu;HE Jialin;CHEN Sa;CHENG Qiang

机构地区：[1]抗生素研究与再评价四川省重点实验室/四川抗菌素工业研究所/成都大学药学院,四川成都610106

出　　处：《科教文汇》2021年第35期118-121,共4页Journal of Science and Education

基　　金：四川省科技厅重点项目“抗痛风新药托匹司他合成新工艺研究”(编号:2020YFS0065);抗生素研究与再评价四川省重点实验室项目“抗巨细胞药物缬更昔洛韦合成新工艺研究”(编号:ARRLKF19-03)。

摘　　要：该文梳理了开展仿制药一致性评价以来国家政策发布和审评情况,汇总药企的产品申报受理及通过情况,仿制药一致性评价工作取得了较好进展。同时,结合实例分析在仿制药一致性评价背景下高校药学教育的教改成果。高校应积极推进"仿制药一致性评价"引入高校药学教学课堂,加强实验平台建设,丰富实践教学模式;教师要积极转变教学理念,探索校企联培机制,培养优秀药学人才,共同推进仿制药一致性评价进程。After sorting out the national policy and review since the launch of the generic drug consistency evaluation,and summarizing the product acceptance and approval status of pharmaceutical companies,it is found that good progress has been made in the consistency evaluation of generic drugs.The results of the educational reform of pharmacy education in colleges and universities are analyzed under the background of the consistency evaluation of generic drugs by combining examples.Colleges and universities should actively promote the introduction of“generic drug consistency evaluation”into their pharmacy teaching classrooms,strengthen the construction of experimental platforms,and enrich practical teaching models.Teachers should change their teaching concepts,explore the school-enterprise joint training mechanism,cultivate outstanding pharmacy talents,and jointly promote the consistency evaluation process of generic drugs.

关 键 词：仿制药 一致性评价 药学教育 人才培养 

分 类 号：G642[文化科学—高等教育学]