| 引用本文：颜建周, 李大双, 丁文静, 邵蓉.基于全周期管理的中美日仿制药替代促进政策对比研究[J].中国卫生政策研究,2023,16(4):37-43 |
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| 基于全周期管理的中美日仿制药替代促进政策对比研究 |
| 投稿时间：2022-11-09 修订日期：2023-03-12 PDF全文浏览 HTML全文浏览 |
| 颜建周, 李大双, 丁文静, 邵蓉 |
| 中国药科大学国家药物政策与医药产业经济研究中心 江苏南京 211198 |
| 摘要:目的:基于全周期管理理念，从仿制药研发注册、市场准入、临床使用和上市后再评价多个环节为我国仿制药替代促进政策的制定和完善提供建议。方法:采用文献研究法和对比分析法，对我国和美日的仿制药替代促进政策现状进行对比分析。结论:仿制药替代是涉及多个环节的系统工程，美国和日本通过在研发注册环节不断完善技术标准和数据指南，在市场准入环节合理定价和医保激励，在临床使用环节管理医师药师处方行为、加强宣传教育，在上市后再评价环节对仿制药进行再评价和替代效果评估，构建了全周期的仿制药替代促进政策体系，实现了仿制药替代目标。 |
| 关键词:仿制药替代 医保支付 仿制药一致性评价 |
| 基金项目:教育部人文社会科学研究规划基金(22YJAZH126) |
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| A comparative study on the promotion policies of generic drug substitution between China, the United States and Japan based on full cycle management |
| YAN Jian-zhou, LI Da-shuang, DING Wen-jing, SHAO Rong |
| The Research Center of National Drug Policy ＆ Ecosystem, China Pharmaceutical University, Nanjing Jiangsu 211198, China |
| Abstract:Objective: Based on the concept of full-cycle management, this paper provides suggestions for the formulation and improvement of generic drug substitution promotion policies in China from multiple links such as generic drug R & D registration, market access, clinical use, and post-marketing reevaluation. Methods: Using comparative analysis method and literature research approach, the current state of generic drug substitution promotion policies in China, the United States and Japan are compared and analyzed. Conclusions: Generic drug substitution is a systematic engineering involving multiple links, and the United States and Japan have addressed this topic by continuously refining technical standards and data guidelines in the R & D registration link, reasonable pricing and medical insurance incentives in the market access link, managing the prescription behavior of physicians and pharmacists in the clinical use link, enhancing publicity and education, and reevaluating and evaluating substitution effects of generic drugs in the post-marketing reevaluation link. A full cycle policy system of generic drug substitution promotion is constructed and the objectives of generic drug substitution are achieved. |
| Key words:Generic drug substitution Medical insurance payment Consistency evaluation of generic drugs |
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