| 邓雯姬,许广宁.广东省已上市中药制剂备案变更常见问题分析与建议[J].中国药事,2024,38(4):381-387 |
| 广东省已上市中药制剂备案变更常见问题分析与建议 |
| Analysis and Suggestion on Common Problems of Post-marketing Chinese Medicine Preparation for Record Changes in Guangdong Province |
| 投稿时间：2024-02-04 |
| DOI：10.16153/j.1002-7777.2024.04.003 |
| 中文关键词: 上市后 备案变更 中药制剂 常见问题 分析建议 |
| 英文关键词: post-marketing record changes Chinese medicine preparation common problems analytical suggestions |
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| 中文摘要: |
| 目的：为我国已上市中药制剂备案变更提供指导与建议。方法：通过整理2023年广东省已上市中药制剂备案变更的受理审评情况，分析持有人申报变更存在的问题及其主要原因，从变更的事前事中事后提出可行建议。结果与结论：对213个已上市中药制剂备案变更品种进行梳理，发现持有人在备案变更方面主要存在申报程序不合规、备案内容不标准、研究验证不充分的问题。建议持有人变更前合理确立变更事项、变更时科学开展研究验证、变更后持续关注风险管理，提升中药制剂备案变更的能力。 |
| 英文摘要: |
| Objective: To provide guidance and suggestions for the record changes of post-marketing Chinese medicine preparation in China. Methods: By sorting out the acceptance and review of the record changes of post-marketing Chinese medicine preparation in Guangdong province in 2023, the problems and main reasons of the holder's declaration of the changes were analyzed, and feasible suggestions were put forward from the events before, during and after the change. Results and Conclusion: After sorting out the 213 varieties of postmarketing Chinese medicine preparation for record changes, it was found that the holders mainly had problems in record changes such as non-compliance of the declaration procedure, the non-standard fi ling content, and the non-sufficient of research verification. It is suggested that the hold er should reasonably establish the changes before the change, conduct scientifi cally research verifi cation during the change, continue to pay attention to risk management after the change, and improve the ability of Chinese medicine preparation record changes. |
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