| 赵燕君,赵霞,谢兰桂,杨会英,肖新月.国内外对药品上市后包装材料的变更管理概述[J].中国药事,2022,36(8):903-912 |
| 国内外对药品上市后包装材料的变更管理概述 |
| Overview of Post-marketing Management on the Changes of Pharmaceutical Packaging Materials at Home and Abroad |
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| DOI：10.16153/j.1002-7777.2022.08.008 |
| 中文关键词: 药品 药包材 变更 风险判定 评估 |
| 英文关键词: drugs pharmaceutical packaging materials change risk determination assessment |
| 基金项目: |
| 作者 | 单位 | | 赵燕君 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 赵霞 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 谢兰桂 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 杨会英 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 | | 肖新月 | 国家药品监督管理局药用辅料质量研究与评价重点实验室,中国食品药品检定研究院,北京 100050 |
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| 中文摘要: |
| 目的：介绍药品上市后包装材料变更的国内外管理模式和技术要求概况，对我国相关管理制度中的薄弱点提出意见和建议，以确保药品上市后的安全、有效和质量可控。方法：通过汇总分析目前我国和美日欧对药品上市后包装材料变更管理的法律法规、指导原则和技术要求，研究其异同点。结果： 国内外对药品上市后包装材料的变更要求多数涵盖在药品的变更要求中，变更管理的总体考虑、关注重点、变更情形和研究验证工作基本相同，并且都特别关注变更风险；不同的是美日欧对药包材自身变更的要求在备案文档中均有明确规定，我国关联审评审批相关政策文件还没有具体要求。另外，各国对部分变更类别的风险判定尺度不同，国外更注重变更风险级别的动态评估。结论：在ICH Q12指导原则基础上，结合药品包装材料的材质风险和使用风险，制定更加科学有效的药品上市后包装材料变更管理制度是大势所趋。 |
| 英文摘要: |
| Objective: To introduce the general situation of management mode and technical requirements for the changes of pharmaceutical packaging materials after drug marketing at home and abroad and put forward suggestions and improvement on the weak points of China's relevant regulations in order to ensure the safety, effectiveness and controllable quality of the post-marketing drugs. Methods: The similarities and differences were studied by summarizing and analyzing the current laws and regulations, guiding principles and technical requirements and management for the post-approval changes of the pharmaceutical packaging materials at home and abroad. Results: Most of the requirements for the packaging materials' changes were covered in the requirements for drug changes after drug marketing at home and abroad. The overall considerations, focuses, change situations and research verifi cation on the changes were basically the same, and the change risks were given special attention too. The difference is that the requirements for self-change of the packaging materials in the United States, Japan and Europe are clearly stipulated in the fi ling documents, while there are no specifi c requirements for relevant policy documents about the bundling review and approval in our country. In addition, diff erent countries have diff erent risk assessment scales for some type of changes and foreign countries pay more attention to dynamic assessment of the risk levels of change. Conclusion: It is the general trend to formulate a more scientifi c and eff ective post-marketing management regulation for the changes under the guideline of ICH Q12, combined with the material risk and the usage risk of drug packaging materials. |
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