仿制药一致性评价的背景、实施及结局  

The background,implementation and outcome of the consistency evaluation of generic drugs

作　　者：苏华[1] 郭瑞臣[2] SU Hua;GUO Rui-chen(Department of Pharmacy,The Second People’s Hospital of Liaocheng/The Second Hospital of Liaocheng Affiliated to Shandong First Medical University,Shandong Linqing 252600,China;Institute of Clinical pharmacology,QILU Hospital of Shandong University,Shandong Jinan 250012,China)

机构地区：[1]聊城市第二人民医院/山东第一医科大学附属聊城二院药学部,山东临清252600 [2]山东大学齐鲁医院临床药理研究所,山东济南250012

出　　处：《中国医院药学杂志》2022年第14期1502-1505,共4页Chinese Journal of Hospital Pharmacy

摘　　要：我国是仿制药大国,开展仿制药质量和疗效一致性评价是国际惯例,也是我国经济、技术水平进步的必然结果。仿制药一致性评价适应国家新政,选择合适终点指标进行研究,目的是提高社会认可、实现仿制药与原研药的真正互换。仿制药一致性评价从简单的体外溶出度试验到系统的药学评价再到生物等效性评价,评价方法正在逐步完善,同时明确化学仿制药参比制剂遴选原则以减少仿制过程中的质量差异。仿制药一致性评价不仅能够提升我国制药行业的整体发展水平,促进医药产业升级和结构调整,同时可以节约医疗费用,保证患者用药安全。China is a largecountry of generic drugs.It is an international practice to carry out the consistency evaluation of the quality and efficacy of generic drugs,and it is also the inevitable result of the progress of economic and technological level.The consistency evaluation of generic drugs adapts to the new national policy,and selects appropriate endpoint indicators for research.The purpose is to improve social recognition and realize the true exchange of generic drugs and original drugs.The evaluation method of generic drug consistency is gradually improving from simple in vitro dissolution test to systematic pharmaceutical evaluation and then to bioequivalence evaluation.The selection principles of reference preparations for chemical generic drugs are clarified to reduce quality differences in the generic process.The consistency evaluation of generic drugs what can improve the overall development level of pharmaceutical industry,promote the upgrading and structural adjustment of the pharmaceutical industry,and save medical expenses and ensure the safety of patients’ medication.

关 键 词：仿制药 一致性评价 生物等效 

分 类 号：R951[医药卫生—药学]