药包材是保障药品质量稳定和安全的重要要素，药包材附录的发布标志着我国药包材监管迈入系统化、规范化的新阶段。梳理了药包材管理过程中药包材生产企业、药品生产企业和药品监管部门存在的典型问题，并提出强化企业主体责任、完善监管机制、发挥社会技术力量的针对性的应对措施，可为药包材生产企业、药品生产企业和药品监管部门开展药包材管理提供参考。

Pharmaceutical packaging materials are an important element in ensuring the stability and safety of drug quality, and the release of the appendix of pharmaceutical packaging materials marks a new stage of systematic and standardized supervision of pharmaceutical packaging materials in China. This article summarizes the typical problems that exist in the management process of pharmaceutical packaging materials in pharmaceutical packaging material production enterprises, drug production enterprises, and drug regulatory authorities. It also proposes targeted measures to strengthen the main responsibility of enterprises, improve regulatory mechanisms, and leverage social and technological capabilities. These measures can provide reference for pharmaceutical packaging material production enterprises, drug production enterprises, and drug regulatory authorities to carry out pharmaceutical packaging material management.

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