| 卢雪明,杨迎迎,王春芳,赵兰婷,马玲玲,尹宁宁,武海军.山东省中药配方颗粒变更上市备案现状及建议[J].中国药事,2024,38(7):757-762 |
| 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 ofTraditional Chinese Medicine Formula Granules in Shandong Province |
| 投稿时间：2024-02-08 |
| DOI：10.16153/j.1002-7777.2024.07.005 |
| 中文关键词: 中药配方颗粒 高质量发展 变更上市备案 中药科学监管 |
| 英文关键词: traditional Chinese medicine formula granules high-quality development change after listing forrecord scientifi c regulation of traditional Chinese medicine |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: To study the present situation of chang after listing for record of traditional Chinesemedicine formula granules (TCMFGs) by taking Shandong province as an example, so as to provide reference forthe standardization and scientifi c regulation of the change. Methods: The relevant laws and regulations and theactual situation of the State and Shandong province on change after listing for record were analyzed, the problemsexisting in the changes were summarized, and reasonable suggestions on the requirements for chang afterllisting for record data were puts forward. Results and Conclusion: After 30 years' development, the industryof TCMFGs made good achievements and encountered new problems. Based on the laws and regulations ofchange in TCMFGs and the record work practice of Shandong province, this article summarized and analyzed theproblems existing in the change of enterprise name, quality standard, packaging materials, excipients/packagingmaterials manufacturers and production process. In order to ensure the quality of the change of TCMFGs, it issuggested that the supervisor should strengthen the policy guidance and technical guidance, and the enterprisesshould play the main responsibility and scientifi cally evaluate the necessity and rationality of the change, manymeasures should be taken to ensure the high-quality development of TCMFGs and provide reference for the scientifi c regulation of Chinese medicine. |
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