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目的:通过分析上海市药包材生产企业管理、产品质量及食药监部门监管有效性等方面的现状和存在的主要问题,提出进一步提高药包材质量水平和监管水平的监管建议。方法:对上海市药包材生产企业的企业现状、产品现状、监管现状等进行研究,对监管部门的监督抽验、案件情况进行实证分析;对相关法律、法规、规章、规范性文件进行文献研究。结果与结论:上海市药包材生产企业未能摆脱多、小、散的状况;企业“重注册轻日常管理”的问题突出,法律法规不完善客观上造成了监管部门“重抽验轻日常监管”。建议提高准入门槛,出台《上海市直接接触药品的包装材料和容器生产企业日常监督管理办法》,加强药包材生产企业日常监督管理。
OBJECTIVE: By analyzing the current situation and main problems in the management of drug packaging materials manufacturing enterprises in Shanghai, the quality of products and the regulatory effectiveness of food and drug regulatory authorities, the paper puts forward some regulatory proposals to further improve the quality and level of drug packaging materials. Methods: The current situation, product status quo and supervision status of pharmaceutical packaging material enterprises in Shanghai were studied, and the supervision and inspection of the regulatory authorities and the case were analyzed empirically. The related laws, regulations, rules and normative documents were also studied . RESULTS AND CONCLUSION: The problems of the pharmaceutical packaging material manufacturers in Shanghai were not able to get rid of many, small and scattered enterprises. The problem of “re-registration of light daily management” was outstanding. The imperfect laws and regulations objectively caused the regulatory authorities to “ Light daily supervision ”. It is suggested to increase the access threshold and promulgate the “Measures for the Daily Supervision and Administration of Packaging Materials and Containers for Direct Contact with Drugs in Shanghai” to strengthen the daily supervision and management of pharmaceutical packaging materials manufacturers.