医疗机构传统中药制剂备案管理工作的分析与思考

Analysis and reflection on the filing management of traditional Chinese medicine preparations in medical institutions

目的对比研究国家及各省份出台的医疗机构应用传统工艺配制中药制剂(以下简称"传统中药制剂")备案管理工作制度的配套政策及开展情况,为该类制剂后续备案监督管理工作的优化推进提供参考。方法通过对原国家食品药品监督管理总局公布的《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》)及各省局出台的通告和具体实施细则,选取10个省份近3年的备案数据进行比较、梳理、统计、分类归纳,研究备案工作政策特征及进展情况。结果与结论部分省份结合本地区实际情况因地制宜地细化或扩充明确了《公告》政策中的传统中药制剂范围,不得备案的情形,备案申报流程及工作时间要求,备案信息公开、变更及取消的情形,监督管理工作开展等几个部分的内容。10个省份备案数据的统计结果显示,与2019年相比,2020年进行备案的中药传统制剂数量、申报备案医疗机构数量同比增幅分别达91.0%、48.8%。笔者认为传统中药制剂备案配套政策仍有提升空间,可考虑借鉴部分省份实施政策中有特色的细则部分进行优化,细化规范标准建设,加强监管体系平台构建:事前做好政策优化落地,加强申报机构能力建设;事中基于风险开展日常监管,控制风险;事后强调追踪监管,强化医疗机构不良反应监测体系建设,建设性地开展全生命周期监督管理工作,以进一步助推医疗机构传统中药制剂的发展。

OBJECTIVE To compare and study the supporting policies for the filing management system of traditional Chinese medicine preparation prepared by traditional technology(hereinafter referred to as“TCM preparation”) in medical institutions issued by the state and various provinces,and their development,so as to provide reference for the improvement of the follow-up supervision and management of the filing works. METHODS According to Announcement on the Filing Management of TCM Preparations Prepared by Medical Institutions Using Traditional Processes issued by former National Food and Drug Administration(hereinafter referred to as the Announcement)as well as notices and specific implementation rules issued by provincial bureaus,the filing work data of 10 provinces in recent 3 years were selected for comparison,sorting,statistics,classification and induction. The policy characteristics and progress of filing work were studied. RESULTS & CONCLUSIONS According to the local actual situation,some provinces had refined or expanded the contents of several parts of the Announcement,such as the scope of TCM preparations,the situation not allowed to record,the filing process and working time requirements,the disclosure,change and cancellation of filing information,and the implementation of supervision and management. The statistical results of filing data in 10 provinces showed that compared with 2019,the number of TCM preparation declared for filing and medical institutions declared for filing had increased with growth rate of 91.0% and 48.8% respectively in 2020. There is still room for improvement in the supporting policies for the filing of TCM preparations,which can be optimized by referring to the features of some provinces’ implementation policies,refining the construction of norms and standards,and strengthening the construction of regulatory system platform. It is necessary to optimize policy and strengthen the capacity building of reporting institutions in advance;carry out daily supervision and control risk based on risk during the filing management;emphasize follow-up supervision, strengthen the construction of ADR monitoring system in medical institutions,and carry out life cycle supervision and management constructively afterwards,in order to promote the further development of TCM preparations in medical institutions.