第三批《鼓励仿制药品目录》纳入品种与优化策略研究——兼与第一批、第二批的比较  

Study on the Inclusion of Varieties and Optimization Strategy of the Third Batch of"Catalogue of Generic Drugs Encouraged for Production"——Comparison with the First and Second Batches

作　　者：冯雨莉 汤少梁 FENG Yuli;TANG Shaoliang(School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing Jiangsu 210023,China;不详)

机构地区：[1]南京中医药大学卫生经济管理学院,江苏南京210023

出　　处：《卫生经济研究》2024年第9期66-68,73,共4页

基　　金：国家自然科学基金面上项目“药改新政背景下基于免疫理论的仿制药供给系统安全预警与应急管理”(72074125)。

摘　　要：目的:探讨国家《鼓励仿制药品目录》政策执行中存在的不足,为更好地完善和实施目录提供参考。方法:采用描述性分析方法,分析我国第三批《鼓励仿制药品目录》纳入品种的特点,评估前两批目录的实施效果。结果:第三批《鼓励仿制药品目录》收录了39个品种,涉及75个品规和13种剂型,纳入了新型药物制剂,覆盖了多个治疗领域,成功填补了部分临床用药的空白;但前两批目录仍有大量药品尚未上市,优先审评的数量也不足。结论:目前,三批《鼓励仿制药品目录》仍有大量药品未上市,政府应加强跨部门合作,根据实际需求不断调整目录,完善激励措施,激发企业研发仿制药品的积极性,并优化仿制药品的审评流程,加快高质量药品的上市进程。Objective To explore the shortcomings in the implementation of national policy of"Catalogue of Generic Drugs Encouraged for Production",and to provide reference for better improvement and implementation of the catalogue.Methods Descriptive analysis was used to analyze the characteristics of the varieties included in the third batch of"Catalogue of Generic Drugs Encouraged for Production"in China,and the implementation effect of the first two batches of the catalogue was assessed.Results The third batch of the catalogue included 39 varieties,involving 75 product specifications and 13 dosage forms,incorporating new drug formulations,covering multiple therapeutic areas,and successfully filling some of the gaps in clinical use.Conclusion At present,there are still a large number of drugs in the three batches of"Catalogue of Generic Drugs Encouraged for Production"that are not yet on the market.The government should strengthen cross-departmental cooperation,continuously adjust the catalogue according to actual needs,improve relevant incentive measures to stimulate the enthusiasm of enterprises to research and develop generic drugs,and further optimize the review process of generic drugs to accelerate the marketing process of high-quality drugs.

关 键 词：仿制药品 鼓励仿制药品目录 国家医保目录 优先审评 

分 类 号：R95[医药卫生—药学]