药品网络销售现状分析及监管对策

Current Situation of Drug Online Sales and Regulatory Countermeasures

目的促进药品网络销售的规范化管理。方法基于《药品网络销售监督管理办法》《药品经营质量管理规范附录6:药品零售配送质量管理》等相关法律法规,分析药品网络销售的现状及存在的问题,提出药品网络销售新模式下《药品经营质量管理规范》(GSP)执法实践的监管对策与建议。结果与结论互联网销售新模式下,药品网络销售存在监管难,网络“水军”虚假交易导致销售乱象,无法有效实施GSP要求的储存条件与销售流向监管,售后与不良反应信息收集难等困境。建议通过“以网管网”“以快制快”的监管手段增强监管力度,加强第三方平台企业自律意识及企业主体责任,持续提升药品流通全过程的质量安全管理能力等,规范药品网络销售市场秩序,应对药品网络销售监管难题,提升群众用药可及性。

Objective To promote standardized management of drug online sales.Methods Based on relevant laws and regulations such as the Measures for the Supervision and Administration of Online Drug Sales and the Appendix 6 of the GSP:Quality Management of Drug Retail Delivery,the current situation and existing problems of online drug sales were analyzed,and the regulatory measures and suggestions for the enforcement practice of the GSP under the new model of online drug sales were put forward.Results and Conclusion Under the new model of drug online sales,there are regulatory difficulties in drug online sales,false transactions caused by the"online water army"lead to sales chaos,inability to effectively implement the storage conditions and sales flow supervision required by GSP,and difficulties in collecting after-sales and adverse reaction information.It is recommended to strengthen supervision through regulatory measures such as"network management"and"quick control",strengthen the self-discipline awareness and main responsibility of third-party platform enterprises,continuously improve the quality and safety management ability of the entire process of drug circulation,standardize the order of the drug online sales market,respond the difficulties of drug online sales supervision,and improve the accessibility of medication for the public.