中药配方颗粒跨省备案存在的问题及原因分析
Analysis of problems and reasons for cross-provincial record-keeping of traditional Chinese medicine dispensing granule
郭春彬 1刘斗2
作者信息
- 1. 山东省食品药品审评查验中心,山东济南 250014
- 2. 山东省药品监督管理局,山东济南 250014
- 折叠
摘要
目的 研究中药配方颗粒生产企业办理跨省备案存在的问题,为中药配方颗粒生产企业提升备案资料质量提供参考.方法 以山东省收到的中药配方颗粒生产企业跨省备案资料为研究对象,对备案资料中发现的问题进行分析总结.结果 中药配方颗粒生产企业的跨省备案(山东省)资料的完整性、生产资质、国家标准与省级标准的应用、备案凭证效期及备案凭证继承等方面均存在问题.结论 企业需要认真学习中药配方颗粒有关的法律法规和政策,准确把握跨省销售备案资料的要求,及时根据国家中药配方颗粒标准的变化,进行调整有关跨省备案的资料提交,切实履行中药配方颗粒质量保证的主体责任,确保跨省备案资料的真实、完整和可追溯.
Abstract
Objective To study the problems of cross-provincial record-keeping of Chinese medicine formula granule enterprises,and to provide reference for Chinese medicine formula granule enterprises to improve the quality of record-keeping data.Methods The cross-provincial record data submitted by the Pharmaceutical Business Application System of National Medical Products Administration were taken as the research object,the problems found in the record materials are analyzed and summarized by the method of summary and induction.Results There are issues with the completeness of cross provincial registration(Shandong Province)documents,production qualifications,application of national and provincial standards,validity period of registration certificates,and inheritance of registration certificates for traditional Chinese medicine formula granule production enterprises.Conclusion the manufacturers of TCM formula granules need to study the laws,regulations and policies related to TCM formula granules,accurately grasp the requirements of cross-provincial sales records,and timely according to the changes of the national standard of TCM formula granules,to adjust the cross-provincial information submis-sion,effectively carry out the main responsibility of quality assurance of traditional Chinese medicine formula particles,to en-sure the authenticity,integrity and traceability of cross-provincial information.
关键词
中药配方颗粒/跨省备案/申报资料/问题/建议Key words
Chinese medicine formula granule/Cross-provincial record/Declaration data/Problems/Suggestions引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据