医疗机构中药制剂备案管理比较研究

Comparative Study on the Archival Management of Traditional Chinese Pharmaceutical Preparations in Medical Institutions

目的:比较分析各医疗机构中药制剂备案管理工作的开展情况,为后续完善备案制度提供参考。方法:探析国家药品监督管理局发布的《关于对医疗机构应用传统工艺配制中药制剂实施备案管理的公告》(以下简称《公告》)与各省及直辖市出台的备案制实施细则和内容,选取8省市近5年来备案数据进行整理、比较和分析。结果:部分省市在《公告》基础上结合本地实际情况细化或扩充了备案范围、中药制剂品种取消备案、备案申报流程等内容。统计情况显示,2018-2020年各省市备案及备案机构数量呈逐年递增趋势,2021-2022年备案及备案机构数量有所减少。结论:通过分析发现医疗机构传统中药制剂存在相关制度不完善、申报配制制剂的医疗机构增长乏力、监管难度加大、中药制剂人才培养机制不健全等问题。建议落实各类激励政策,完善备案制制度;激励医疗机构配制中药制剂,加大投入;加强医疗机构中药制剂监管力度;加强专业人才队伍建设;加强宣传引导,引导医疗机构中药制剂向中药新药转化等。最终推动医疗机构中药制剂的良性发展,促进中医药事业的繁荣昌盛。

Objective:To compare the archival management of traditional Chinese medicine(TCM)preparations in medical institutions to provide reference for the subsequent improvement of the archival filing system.Methods:Compared with the Announcement on the Filing Management of the Formulation of Medical Institutions(hereinafter referred to as the Announcement)and the Detailed Rules of the implementation rules of the filing system issued by the provinces and municipalities directly under the Central Government,the archival data of 8 provinces and cities in the past five years were selected for sorting,comparison and analysis.Results:On the basis of the Announcement,some provinces have refined or expanded the scope of filing,the cancellation of the filing of TCM preparations,and the filing and declaration process in combination with the actual situation of the province.Statistics show that from 2018 to 2020,the number of filing and filing institutions in all provinces and cities was increasing year by year,and the number of filing and filing institutions decreased from 2021 to 2022.Conclusion:Through the analysis,it is found that the TCM preparations in medical institutions are not perfect,the application of medical preparation is not obvious,the supervision difficulty is increased,and the imperfect talent training mechanism of TCM preparations.It is suggested to implement various incentive policies and improve the filing system;encourage medical institutions to prepare TCM preparations and increase investment;strengthen the supervision of TCM preparations;strengthen the construction of professional talents,strengthen publicity and guidance to guide medical institutions to transform TCM preparations into TCM drugs.In order to promote the development of traditional Chinese medicine preparations in medical institutions,and then promote the development of traditional Chinese medicine cause.