山东省中药配方颗粒变更上市备案现状及建议
Present Situation and Suggestions on the Chang after Listing for Record of Traditional Chinese Medicine Formula Granules in Shandong Province
卢雪明 1杨迎迎 1王春芳 1赵兰婷 1马玲玲 1尹宁宁 1武海军1
作者信息
- 1. 山东省食品药品审评查验中心,济南 250014
- 折叠
摘要
目的:以山东省为例,对中药配方颗粒变更上市备案情况进行研究,为变更的规范开展和科学监管提供参考.方法:分析国家及山东省变更上市备案相关法规和实际情况,汇总变更存在的问题,并对变更上市备案资料要求等提出合理化建议.结果与结论:中药配方颗粒产业经过30年的发展,取得了较好成绩,也遇到了新的问题.本文结合中药配方颗粒变更法规和山东省备案工作实践,对变更企业名称、质量标准、包装材料、辅料/包装材料生产商、生产工艺方面存在的问题进行汇总分析.为确保中药配方颗粒的变更质量,建议监管方加强政策引领和技术指导,企业发挥主体责任、科学评估变更的必要性和合理性,多举措保障中药配方颗粒产业高质量发展,为中药科学监管提供参考.
Abstract
Objective:To study the present situation of chang after listing for record of traditional Chinese medicine formula granules(TCMFGs)by taking Shandong province as an example,so as to provide reference for the standardization and scientific regulation of the change.Methods:The relevant laws and regulations and the actual situation of the State and Shandong province on change after listing for record were analyzed,the problems existing in the changes were summarized,and reasonable suggestions on the requirements for chang after llisting for record data were puts forward.Results and Conclusion:After 30 years'development,the industry of TCMFGs made good achievements and encountered new problems.Based on the laws and regulations of change in TCMFGs and the record work practice of Shandong province,this article summarized and analyzed the problems existing in the change of enterprise name,quality standard,packaging materials,excipients/packaging materials manufacturers and production process.In order to ensure the quality of the change of TCMFGs,it is suggested that the supervisor should strengthen the policy guidance and technical guidance,and the enterprises should play the main responsibility and scientifically evaluate the necessity and rationality of the change,many measures should be taken to ensure the high-quality development of TCMFGs and provide reference for the scientific regulation of Chinese medicine.
关键词
中药配方颗粒/高质量发展/变更上市备案/中药科学监管Key words
traditional Chinese medicine formula granules/high-quality development/change after listing for record/scientific regulation of traditional Chinese medicine引用本文复制引用
出版年
2024
NETL
NSTL
万方数据