国家基本药物质量监管中存在的问题及对策

Problems and countermeasures on regulation of national essential medicines quality

本文分析了我国基本药物生产、流通和使用环节的质量监管现状和问题,指出药品监管部门要监督指导生产企业的工艺和处方的自查,严格审批委托生产的条件,保证中药制剂的质量可控。制定基本药物配送企业的遴选标准,对进货、验收、储存、出库、运输等环节加强监管,引入药品电子监管码。应加强对医疗机构的基本药物监管,并通过行政检查、信息披露等监管方式,来保障基本药物安全。

This paper analyzes the current situations and issues in essential medicines regulation, and gives some suggestions for improvement. Drug manufacturers should improve production process and engage in self-control, contract manufacturing should be strictly controlled; the quality of traditional Chinese medicine should comply with statutory requirements. Regulation agencies should set up criteria in selecting eligible distribution enterprises; regu- late stocking, checking, delivering and transporting of drug sellers. Electronic monitoring code should be introduced. The use of essential drugs in hospitals should be regulated by drug regulatory agencies. ments such as administrative investigation and information disclosure should be utilized quality of essential medicines.