| 张涛志,卓剑锋,张青松,尹续续,刘伟.我国药品第三方物流监管政策分析[J].中国药事,2021,35(8):877-885 |
| 我国药品第三方物流监管政策分析 |
| Analysis of Pharmaceutical Third-Party Logistics Supervision Policies in China |
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| DOI：10.16153/j.1002-7777.2021.08.005 |
| 中文关键词: 第三方物流 医药物流 药品流通 |
| 英文关键词: third-party logistics pharmaceutical logistics drug circulation |
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| 摘要点击次数: 557 |
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| 中文摘要: |
| 目的：比较各省药品第三方物流监管政策，为加强药品第三方物流科学监管，促进其健康发展提出建议。方法：检索各省级药品监督管理局网站，获取药品第三方物流监管的有关政策文件，对比分析，并提出建议。结果：各省加强药品第三方物流监管的意见、指导原则及其指南等大都集中在资质、 委托范围、药品第三方物流企业硬件软件和机构人员、质量审计和质量协议、委托方和药品第三方物流企业责任划分规定和召回追溯、法律责任及处罚的规定等6个方面，但政策的具体规定及执行落实情况有所差别。结论：各省应该加强对药品第三方物流的科学监管，放宽准入企业类型范围，明确委托范围和委托方式，严格药品第三方物流基本要求，强化质量审计和制定质量协议示范文本，明确各方责任划分，确保召回追溯高效有序。 |
| 英文摘要: |
| Objective: The regulatory policies of the third-party drug logistics in different provinces were compared, and suggestions were put forward to strengthen the scientific supervision of the third-party logistics of pharmaceuticals and promote its healthy development. Methods: The websites of provincial drug administration were searched to obtain the related policy documents of pharmaceutical third-party logistics supervision, comparative analysis was made, and suggestions were put forward. Results: Suggestions, guiding principles and guidelines on strengthening the supervision of pharmaceutical third-party logistics in various provinces mainly concentrate on the six aspects of qualification, entrusted scope, hardware, software and organization personnel of pharmaceutical third-party logistics, quality audit and quality agreement, responsibilities of the entrusting party and pharmaceutical third-party logistics, recall traceability, legal liability and provisions for punishment. There exist differences in the specific provisions and implementation of policies. Conclusion: The provinces should strengthen scientific supervision of pharmaceutical third-party logistics, expand the scope of access enterprises, clarify the scope and mode of entrusting, strictly enforce the access conditions of pharmaceutical third-party logistics, strengthen quality audit, formulate quality agreement model texts, clarify the responsibility division of all parties, and ensure the efficient and orderly recall and traceability. |
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