摘 要 目的：为加强医疗机构的药品质量监管提供参考和依据。方法：从立法角度分析医疗机构药品质量监管存在的问题，提出加强我国医疗机构药品质量监管的对策及完善我国医疗机构药品质量监管的修法建议。结果与结论：目前，医疗机构药品质量监管存在药房设置缺乏强制性标准、药品常规监管多为形式监管、对医疗机构涉药违法行为的处罚过轻等监管手段有限等问题。为加强我国医疗机构药品质量监管，建议相关部门应制定医疗机构药房设置的强制性标准及增设审核环节、制定适用于全国的《药品使用质量管理规范》。在完善我国医疗机构药品质量监管法律时，可在《中华人民共和国药品管理法》《药品管理法实施条例》中增加相应条款，修改并完善《医疗机构管理条例》等下位法律法规，以加强对医疗机构药品质量的监管。

    关键词 醫疗机构；药品质量监管；立法；法律规定；监管手段

    ABSTRACT OBJECTIVE： To provide reference and basis for strengthening the drug quality supervision of medical institutions. METHODS： The problems about the drug quality supervision of the medical institutions were analyzed from the angle of legislation. Countermeasures for strengthening drug quality supervision of medical institutions in China as well as legislative suggestions on improving drug quality supervision of medical institutions in China were put forward. RESULTS & CONCLUSIONS： At pre- sent ......