已上市中药制剂生产场地变更管理现状分析

Status Analysis of Traditional Chinese Medicine Preparations in Production Site Change Management

药品变更管理是实现药品质量持续改进的重要方式,也是药品监管的重要部分。已上市药品变更实行分类管理,是药品监管方式和理念的持续优化,也是药品变更管理的重大突破。基于已上市中药制剂生产场地变更管理,本研究梳理了生产场地变更管理历史,分析了新版《药品注册管理办法》实施以来,山东省中药制剂生产场地变更现状以及生产场地变更备案审评过程中常见问题,明确了中药制剂在进行生产场地变更过程中应重点关注的内容。针对中药制剂工艺参数不详细、部分品种质量标准较低、生产过程控制风险增加等问题,提出应继续完善变更管理法律法规体系,加大宣贯培训,强化药品上市许可持有人变更管理理念等建议,以期为已上市中药制剂生产场地变更的科学监管提供参考和技术支持。

Drug change management is an important way to achieve continuous improvement of drug quality,and it is also an important part of drug regulation.The implementation of classified management for changes in marketed drugs is a continuous optimization of drug regulatory methods and concepts,and a major breakthrough in drug change management.Based on the management of changes in the production site of marketed traditional Chinese medicine preparations,this study reviewed the history of production site change management,analyzed the current situation of changes in the production site of traditional Chinese medicine preparations in Shandong Province since the implementation of the new version of the“Drug Registration Management Measures”,as well as common problems in the review process of production site changes,and clarified the contents that should be focused on in the process of production site changes.Finally,several considerations are proposed from the aspects of incomplete process parameters,low quality standards for some varieties,and increased risks in production process control of traditional Chinese medicine preparations.It is proposed to continue to improve the legal and regulatory system for change management,increase publicity and training,and strengthen the management concept of change for drug marketing license holders,in order to provide reference and technical support for the scientific supervision of changes in the production site of marketed traditional Chinese medicine preparations.