Analysis on the operation effect of China’s drug complaints and reporting system
- VernacularTitle:我国药品投诉举报制度运行成效分析
- Author:
Yang LIU
1
;
Haihong JIANG
1
;
Xin YUAN
2
Author Information
1. School of Medical Instrument,Shanghai University of Medicine & Health Sciences,Shanghai 201318,China;Center of Policy Research and Safety Evaluation for Medical Devices,Shanghai University of Medicine & Health Sciences,Shanghai 201318,China
2. School of Medical Instrument,Shanghai University of Medicine & Health Sciences,Shanghai 201318,China
- Publication Type:Journal Article
- Keywords:
drug complaints and reporting;
drug regulation
- From:
China Pharmacy
2025;36(14):1697-1702
- CountryChina
- Language:Chinese
-
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 enterprises to implement the main responsibility, so as to improve the quality and safety of drugs and ensure the safety of public medication.