藥包材是保障藥品質(zhì)量穩(wěn)定和安全的重要要素，藥包材附錄的發(fā)布標(biāo)志著我國藥包材監(jiān)管邁入系統(tǒng)化、規(guī)范化的新階段。梳理了藥包材管理過程中藥包材生產(chǎn)企業(yè)、藥品生產(chǎn)企業(yè)和藥品監(jiān)管部門存在的典型問題，并提出強化企業(yè)主體責(zé)任、完善監(jiān)管機制、發(fā)揮社會技術(shù)力量的針對性的應(yīng)對措施，可為藥包材生產(chǎn)企業(yè)、藥品生產(chǎn)企業(yè)和藥品監(jiān)管部門開展藥包材管理提供參考。

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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