| 董阳.以创新激励为导向的药品注册改革-基于上海市药品上市许可持有人制度的试点经验分析[J].中国药事,2019,33(8):857-863 |
| 以创新激励为导向的药品注册改革-基于上海市药品上市许可持有人制度的试点经验分析 |
| Drug Registration Reform Guided by Innovation Incentives——Analysis of Pilot Experience Based on Shanghai Marketing Authorization Holder System |
| 投稿时间：2019-06-14 |
| DOI：10.16153/j.1002-7777.2019.08.003 |
| 中文关键词: 药品注册改革 创新 药品上市许可持有人 政策试点 政策分析 绩效评估 |
| 英文关键词: drug registration reform innovation marketing authorization holder policy pilot policy analysis performance evaluation |
| 基金项目: |
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| 中文摘要: |
| 目的：以上海市药品上市许可持有人制度试点为视角，分析该制度的机制设计和实施路径，为试点的推广和复制提供参考。方法：基于制度分析和案例分析，聚焦上市许可持有人制度出台背景、设计思路及实施进展，立足上海市的试点经验，分析该制度的优势、成效和潜在风险。结果与结论：药品上市许可持有人制度能够通过合理的制度设计和实施路径安排，从而很好地实现其激励创新的目标，并有效地防范质量安全风险。 |
| 英文摘要: |
| Objective:To analyze its mechanism designation and implementation method to provide references for policy diffusion from the perspective of Shanghai's pilot on Marketing Authorization Holder (MAH) system. Methods:The background, designation and progress of the MAH system were focused on based on institutional analysis and case study. The advantages, effects and risks of the MAH system were analyzed according to Shanghai's pilot experience on the MAH system. Results and Conclusion:The MAH system can achieve its goal to motivate innovation and effectively prevent quality and safety risks by means of reasonable institution design and implementation methods. |
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