| 侯瑾,董爱梅,李德宝,肖连立,杨帆,徐晓娟,刘军田,武海军.山东省化学药品再注册审查现状的分析和思考[J].中国药事,2024,38(8):882-890 |
| 山东省化学药品再注册审查现状的分析和思考 |
| Analysis and Thoughts on the Technical Review of Chemical Drug Reregistrationin Shandong Province |
| 投稿时间：2023-11-03 |
| DOI：10.16153/j.1002-7777.20230939 |
| 中文关键词: 化学药品 药品再注册 技术审查 问题 建议 |
| 英文关键词: chemical drug drug re-registration technical review problems suggestions |
| 基金项目: |
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| 中文摘要: |
| 目的：通过分析山东省药品再注册工作中存在的问题提出相关建议，为促进药品再注册工作科学规范、提高药品再注册工作审查审批效率提供技术参考。方法：基于我国现行药品再注册等法律法规、山东省50家化学药品生产企业调研情况及近几年山东省药品再注册情况，对山东省化学药品（制剂和原料药）再注册技术审查情况进行探讨分析。结果与结论：山东省药品再注册工作中主要存在与上市药品再评价衔接不紧密、药品批准的工艺等无法溯源、批准文号集中到期申报等问题，建议通过统一技术审查标准、深化附条件批准上市药品管理、优化再注册周期管理、强化企业主体责任等措施更好地发挥药品再注册工作上市后监管作用。 |
| 英文摘要: |
| Objective: To analyze the problems existing in the drug re-registration work in ShandongProvince and put forward relevant suggestions, so as to provide technical reference for promoting the scientificstandardization of drug re-registration work and improving the review and approval efficiency of drug reregistrationwork. Methods: Based on the current laws and regulations of drug re-registration in China, theinvestigation of 50 chemical manufacturers in Shandong Province and the situation of drug re-registration inShandong Province in recent years, the technical review of chemical drugs (preparations and raw materials)re-registration in Shandong Province was discussed and analyzed. Results and Conclusion: In the drug reregistrationworks in Shandong Province, there were mainly problems such as the lack of close connection withthe reevaluation of listed drugs, the untraceable process of drug approval, and the centralized deadline declarationof approval document number. It is suggested that measures such as unifying technical review standards,deepening the management of conditional approval of listed drugs, optimizing the management of re-registrationcycle, and strengthening the main responsibility of enterprises can better play the role of post-listing supervisionof drug re-registration. |
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