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

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。

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.