| 吴凡,胡媛,梅蕾蕾,万欣,孙西军,王子千,熊磊,任峰.从药品参比制剂审议未通过和调出品种视角思考参比制剂的遴选[J].中国药事,2022,36(5):483-490 |
| 从药品参比制剂审议未通过和调出品种视角思考参比制剂的遴选 |
| On Reference Selections Based on the Failed and Removed Varieties by RLD Review |
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| DOI：10.16153/j.1002-7777.2022.05.001 |
| 中文关键词: 参比制剂 未通过 调出 遴选建议 仿制药 |
| 英文关键词: reference listed drug (RLD) failure to pass removal selection suggestions generic drugs |
| 基金项目:江西省药品监督管理局科研项目(编号 2021KY21) |
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| 中文摘要: |
| 随着参比制剂审议未通过和调出参比目录数量逐渐增多，笔者首次对该类品种进行梳理，并首次针对“典型问题”通过案例深入分析其无法获得参比制剂地位的关键因素，进一步厘清参比制剂的遴选思路，并提出切实可行的遴选建议，为今后参比制剂的遴选提供借鉴。 |
| 英文摘要: |
| With the gradual increase in the number of the failed and removed catalogue by reference listed drug (RLD) review, this paper sorted out these varieties and analyzed in depth the key factors that prevented them from obtaining the status of RLD through case studies on some “typical problems” for the first time. The selection ideas of RLD were further clarified and some practical selection suggestions were put forward to provide references for the selections of RLD in the future. |
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