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·药事管理·

我国药品投诉举报制度运行成效分析
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刘 洋 1， 2＊ ，蒋海洪 1， 2 # ，袁 鑫（1.上海健康医学院医疗器械学院，上海 201318；2.上海健康医学院医疗器械
1
政策研究与安全评价中心，上海 201318）

中图分类号 R951 文献标志码 A 文章编号 1001-0408（2025）14-1697-06
DOI 10.6039/j.issn.1001-0408.2025.14.02

摘 要 目的 评估我国药品投诉举报制度的运行成效，为完善药品监管制度、提升国家药品科学监管能力提出建议。方法 收集
2012－2023年药品监管统计数据和2023－2024年全国12315消费投诉信息公示平台中各省份及7家药品网络销售第三方平台的
投诉数据，从公众参与度、公众满意度、案件处理效率与处理质量、社会效果和风险预警能力等维度分析药品投诉举报制度的运行
成效。结果 2012－2019年，药品投诉举报受理量波动较大，药品投诉举报立案数整体呈现下降趋势，但公众满意度较高，结案率
持续提高。2023－2024年，药品投诉件数居前5位的省份分别为广东、河南、浙江、山东和上海；网络平台中的药品投诉主要涉及
拼多多、京东商城和淘宝平台销售的中西成药、中成药和中药材等，投诉问题集中于药品质量和售后服务，不同网络平台药品投诉
案件调解协议的达成比例存在明显差异。2021－2024 年，药监部门通过投诉举报线索查处网络销售违规典型案件 11 件。结论
我国药品投诉举报制度运行平稳，建议进一步利用12315消费投诉信息公示平台数据强化重点地区和网络平台的监测，督促企业
落实主体责任，以提升药品质量安全水平，保障公众用药安全。
关键词 药品投诉举报；药品监管；网络销售；风险预警；12315平台

Analysis on the operation effect of China’s drug complaints and reporting system
LIU Yang ，JIANG Haihong ，YUAN Xin（1. School of Medical Instrument， Shanghai University of Medicine
1， 2
1， 2
1
& Health Sciences， Shanghai 201318， China；2. Center of Policy Research and Safety Evaluation for Medical
Devices， Shanghai University of Medicine & Health Sciences， Shanghai 201318， China）
ABSTRACT OBJECTIVE To evaluate the operation effect of the drug complaints and reporting system in China， and put
forward the suggestions for improving the drug supervision system and enhancing the national drug scientific supervision capacity.
METHODS The statistical data of drug supervision from 2012 to 2023 and the complaint data of various provinces and 7 third-
party platforms of drug online sales from National 12315 Consumer Complaint Information Disclosure Platform from 2023 to 2024
were collected. The operation effect of drug complaints and reporting system was analyzed from the dimensions of public
participation， public satisfaction， case handling efficiency and quality， social effect and risk early warning ability. RESULTS From
2012 to 2019， the acceptance of drug complaints and reporting fluctuated greatly， and the number of drug complaints and reporting
cases showed a downward trend as a whole， but the public satisfaction was high and the closure rate continued to increase. From
2023 to 2024， the top five provinces in terms of the number of drug complaints were Guangdong， Henan， Zhejiang， Shandong and
Shanghai. Drug complaints in the online platform mainly involved Chinese and Western medicines， traditional Chinese medicines
and Chinese herbal medicines sold on the network platforms of Pinduoduo， Jingdong and Taobao. The complaints focused on
quality and after-sales service， and there were significant differences in the proportion of mediation agreements in drug complaint
cases. From 2021 to 2024， the drug regulatory authorities investigated and dealt with 11 typical cases of online sales violations
through complaint and reporting clues. CONCLUSIONS The drug complaints and reporting system in China runs smoothly. It is
suggested to further use the data of National 12315 Consumer Complaint Information Disclosure Platform to strengthen the
monitoring of key areas and network platforms， and urge
Δ 基金项目 国家社会科学基金一般项目（No.24BFX130）；上海市
教育科学研究一般项目（No.C24142）；中国药品监督管理研究会研究 enterprises to implement the main responsibility， so as to
课题（No.2023-Y-Q-004） improve the quality and safety of drugs and ensure the safety
＊第一作者 讲师 ，博士。研究方向 ：药品监管法规。E-mail：
of public medication.
821363361@qq.com
# 通信作者 副教授，博士。研究方向：药品、医疗器械政策与监管 KEYWORDS drug complaints and reporting； drug regulation；
法规。E-mail：jianghh@sumhs.edu.cn online sales； risk early warning； 12315 platform

中国药房 2025年第36卷第14期 China Pharmacy 2025 Vol. 36 No. 14 · 1697 ·