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| 基于河南省药品生产技术转移情况探讨药品生产技术转移项目实施的关注要点 |
| Key Point discussion on Drug Production Technology Transfer Project Implementation based on Drug Production Technology Transfer situation in Henan Province |
| 投稿时间：2020-10-31 修订日期：2021-01-31 |
| DOI： |
| 中文关键词: 药品技术转移，上市许可持有人，技术转移要点 |
| 英文关键词: Drug technology transfer, Marketing authorization holders, Key point discussion on drug technology transfer |
| 基金项目:河南省科学技术厅2018年度科技攻关项目(No.182102310762) |
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| 中文摘要: |
| 目的：为药品上市许可持有人实施药品生产技术转移提供参考。方法：分析归纳2015年~2019年河南省药品生产技术转移申报资料中存在的主要问题，依据分析结果探讨药品生产技术转移项目实施的关注要点。结果：对河南省161个药品生产技术转移品种申报资料中存在的问题进行分析归纳，存在问题主要集中在转出方产品资料、生产工艺及工艺验证、质量研究及质量标准、稳定性研究、原辅料及药包材等方面，结合发现的问题并综合实践经验及文献资料着手探讨药品生产技术转移项目实施的关注要点。结论：提出了药品生产技术转移项目实施的关注要点，为拟开展药品生产技术转移的药品上市许可持有人提供参考。 |
| 英文摘要: |
| Objective: To provide references for marketing authorization holders who plan to implement the change research of drug technology transfer. Methods: The main problems existing in the technology transfer in Henan Province from 2015 to 2019 were collected and analyzed. The Key Points of Change Research of Drug Technology Transfer were discussed and summarized based on the analysis results. Results: The problems in 161 drug varieties were mainly distributed into five aspects, including the history of the product, production process and process verification，quality research and quality standards, stability research and the raw material/inner packing material. Based on the experience and the existing problems, the key points of drug technology transfer were summarized. Conclusion: The key points of drug technology transfer are proposed, and they are helpful for the marketing authorization holders who plan to carry out the change research of technology transfer. |
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