| 曹琳琳,郭自聪,周逢源,李琼,李金跃,刘伟.我国药品第三方物流仓储和运输监管政策对比[J].中国药事,2024,38(4):367-376 |
| 我国药品第三方物流仓储和运输监管政策对比 |
| Comparison of Storage and Transportation Regulatory Policies of Drug Thirdparty Logistics in China |
| 投稿时间：2024-02-29 |
| DOI：10.16153/j.1002-7777.2024.04.001 |
| 中文关键词: 药品 第三方物流 仓储 运输 政策对比 |
| 英文关键词: drugs third-party logistics storage transportation policy comparison |
| 基金项目:河南省软科学研究项目（编号 222400410047）；河南省市场监督管理局科技计划项目（编号 2022SJ76） |
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| 中文摘要: |
| 目的：比较各省份在药品第三方物流仓储和运输方面的监管政策，为加强药品第三方物流监管提出可行性建议。方法：通过检索国家药品监督管理局以及各省级药品监督管理局网站，获取有关药品第三方物流仓储和运输方面的监管政策，对比分析各省份政策和《药品经营质量管理规范》相关规定， 并提出建议。结果：通过对比发现，各省份在仓储和运输方面的政策主要集中在仓储面积、仓储设施设备、冷库数量及容积要求、冷库供电保障、温湿度监测系统、仓储管理系统、车辆数量及车载设备、运输车辆管理、特殊药品运输、运输管理系统等方面，但各省份的具体规定又存在一定的差异。而且大多省份的政策文件还存在仓储管理政策不统一、仓储区域划分不明确、仓储设施设备规定不具体、运输相关政策不全面、未对运输常温药品过程中保证常温环境做出规定等问题。结论：药品监管部门应加强对药品第三方物流的科学监管，建立统一的第三方物流管理制度。药品第三方物流企业应当加强基础设施设备建设，努力提高自身仓储运输水平。各相关方共同努力，促进药品第三方物流行业健康有序发展。 |
| 英文摘要: |
| Objective: To compare the regulatory policies of various provinces on the storage and transportation of drug third-party logistics, and to put forward feasible suggestions for strengthening the supervision of drug third-party logistics. Methods: By searching the websites of the National Medical Products Administration and provincial medical products administration, the regulatory policies on drug third-party logistics storage and transportation were obtained, the policies of diff erent provinces and the relevant provisions of the Good Supply Practic were compared and analyzed, and suggestions were put forward. Results: Through comparison, it was found that the policies of various provinces on storage and transportation mainly focused on the storage area, storage facilities and equipment, cold storage quantity and volume requirements, cold storage power supply guarantee, temperature and humidity monitoring system, storage management system, vehicle quantity and vehicle equipment, transportation vehicle management, special drug transportation, transportation management system and other aspects. However, there were some diff erences in the specifi c regulations of diff erent provinces. Moreover, the policy documents of most provinces still had problems: storage management policies were not unifi ed, storage areas were not clearly divided, storage facilities and equipment provisions were not specific, transport-related policies were not comprehensive, and provisions were not made to ensure the normal temperature environment during the transportation of normal temperature drugs. Conclusion: Drug regulatory authorities should strengthen the scientifi c supervision of drug third-party logistics, and establish a unifi ed third-party logistics management system. Drug third-party logistics enterprises should strengthen the construction of infrastructure and equipment, and strive to improve their own storage and transportation level. All relevant parties should make joint eff orts to promote the healthy and orderly development of the pharmaceutical third-party logistics industry. |
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