当前“第三方医药物流”正在逐步进入医药物流市场。对医药物流施行“放管结合”的监管改革,是“十四五”期间国家宏观发展战略的要求,也是构建医药产品上市后监管政策一个不可忽视的要求。现阶段要在加强对“第三方医药物流”质量管理的同时,积极推进全国统一的现代医药物流大市场建设,促进医药物流行业的高质量发展。为此需要充分认知现代医药物流的基本特征,制定全国统一的现代医药物流监管政策,科学研判“第三方医药物流”的安全风险点,完善对医药物流委托事项质量管理要求,健全对“第三方医药物流”的各项行政监管措施,同时探索并完善行业组织对“第三方医药物流”企业能力评价机制。
<<At present,the “third-party pharmaceutical logistics” is gradually entering the pharmaceutical logistics market. It is the requirement of the national macro development strategy during the “14th Five-Year Plan” period to implement the regulatory reform of “Balance the streamline of government administration and empowerment” for pharmaceutical logistics;it is also an area that cannot be ignored in the construction of post-marketing regulatory policy for pharmaceutical products. At this stage,while strengthening the quality management of the “third-party pharmaceutical logistics”,the construction of a unified modern pharmaceutical logistics market should be actively promote in China for high-quality development of pharmaceutical logistics. Therefore,it is necessary to fully understand the basic characteristics of modern pharmaceutical logistics and formulate a unified national regulatory policy on modern pharmaceutical logistics. We need to scientifically study and evaluate the safety risk points of “third-party pharmaceutical logistics”,as well as improve the quality management requirements for entrusted matters of the pharmaceutical logistics and the administrative supervision measures on “third-party pharmaceutical logistics.” At the same time,it is important to explore and complete the evaluation mechanism of the third-party pharmaceutical logistics enterprises by industry enterprises.
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