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王乾,杨浩宇,田侃.我国鼓励仿制药品目录政策实施效果及优化*[J].中国卫生经济,2023,42(12):16-20,101.[点击复制] |
Wang Qian,Yang Haoyu,Tian Kan.The Implementation Effect and Optimization of the Policy of Encouraging Generic Drug Catalogue in China[J].CHINESE HEALTH ECONOMICS,2023,42(12):16-20,101.[点击复制] |
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| 我国鼓励仿制药品目录政策实施效果及优化* |
| 王乾,杨浩宇,田侃 |
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| (南京中医药大学卫生经济管理学院 南京 210023;南京中医药大学养老服务与管理学院 南京 210023) |
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| 摘要: |
| 目的：探讨我国鼓励仿制药品目录的政策实施效果及问题，以期进一步完善仿制药品目录政策。方法：对我国鼓励仿制药品目录遴选原则、纳入药品特点与实施现状、存在的问题等进行分析。结果：两批目录中纳入药品的治疗领域相对集中于神经系统、呼吸系统、肿瘤、内分泌和代谢病及感染性疾病，50个药品中仿制药新增申请有24个药品，已经有2种药品纳入优先审评行列，19种获批上市，20种纳入医保目录。当前，目录发展还存在第二批目录政策实施效果不明显、部分仿制药研发出现“两极分化”现象、优先审评制度的缺失、部门间协调联动待加强等问题。结论：应当完善制度设计，加强参比制剂遴选管理，完善配套激励措施，调动企业研发积极性，动态调整仿制药目录，强化部门协调联动。 |
| 关键词: 仿制药品 政策 实施效果 优化策略 |
| DOI： |
| 投稿时间：2023-09-08 |
| 基金项目:江苏省研究生实践创新计划项目 （SJCX23_0731） ；2023 年江苏省研究生科研与实践创新计划项目（SJCX23_0731） |
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| The Implementation Effect and Optimization of the Policy of Encouraging Generic Drug Catalogue in China |
| Wang Qian,Yang Haoyu,Tian Kan |
| (School of Health Economics Management, Nanjing University of Chinese Medicine, Nanjing, 210023 ,China) |
| Abstract: |
| Objective: To explore the implementation effect and problems of the policy of encouraging generic drug list in China, in order to further improve the policy of generic drug list. Methods: The selection principle of encouraging generic drug list in China, the characteristics and implementation status of included drugs, and the existing problems are analyzed. Results: The therapeutic fields of drugs included in the two batches of catalogs are relatively concentrated in the nervous system, respiratory system, tumor, en- docrine and metabolic diseases and infectious diseases. Among the 50 drugs, there are 24 new applications for generic drugs, 2 drugs are included in the priority review, 19are approved for listing, and 20 are included in the medical insurance catalog. At present, there are still problems in the development of the two batches of catalogs, such as the ineffective implementation of the second batch of cata- log policies, the phenomenon of“polarization”in the research and development of some generic drugs, the lack of priority review sys- tem, and the coordination and linkage between departments to be strengthened. Conclusion: It is necessary to improve the system de- sign, strengthen the selection management of reference preparations, improve the supporting incentive measures, mobilize the enthusi- asm of enterprises in research and development, dynamically adjust the generic drug catalog, and strengthen the coordination and link- age of departments. |
| Key words: generic drugs policy implementation effect optimization strategy |
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