[关键词]
[摘要]
药品抽检中,销售和使用环节抽样的不合格中药饮片在监管过程中经常遇到标示生产企业否认生产的情况。针对这一问题,梳理药品追溯的政策法规,搜集药品质量通告中不合格中药饮片标示生产企业否认生产的情况,借鉴ICHQ9的风险管理工具HACCP进行风险分析和关键控制点分析,建议加强中药饮片追溯法治建设,建全追溯体系,彻查问题产品来源,加强药材市场监管和零售、使用环节监管,联合惩戒制假和故意否认生产行为,为解决这一问题提供参考。
[Key word]
[Abstract]
In the process of supervision, the manufacturer often denies manufacturing the unqualified Chinese herbal pieces sampled from the seller and user. In response to this problem, this article reviews the policies and regulations for drug traceability, collects the denial manufacture of the unqualified Chinese herbal pieces by the labeled manufacturers from the national drug quality announcement, identifies the risks and critical control points with the risk management tool HACCP of ICHQ9. It is recommended to improve the legal system and traceability system for Chinese herbal pieces, investigate the source of the product involved thoroughly, strengthen the supervision of the TCM markets, sellers and users, and punish the illegal behavior jointly, which provides a reference for solving the problem.
[中图分类号]
[基金项目]