欧美与亚洲国家药品监管机构开展药品风险沟通的研究

doi:10.19803/j.1672-8629.2021.09.10

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (9): 845-849.
DOI: 10.19803/j.1672-8629.2021.09.10

欧美与亚洲国家药品监管机构开展药品风险沟通的研究

张丹^1,2, 吕锦涛^1,2, 宋海波³, 张冰^1,2,*, 金勇男⁴, 萨日娜^1,5, 张晓朦^1,2, 林志健^1,2

¹北京中医药大学中药学院,北京 102488;
²北京中医药大学中药药物警戒与合理用药研究中心,北京 102488;
³国家药品监督管理局药品评价中心,药物警戒研究与评价重点实验室,北京 100022;
⁴延边大学附属医院,吉林延吉 133000;
⁵甘肃省人民医院药剂科,甘肃兰州 73000

收稿日期:2020-08-19 出版日期:2021-09-15 发布日期:2021-09-18
通讯作者: ^*张冰,女,博士后,教授·博导,主任医师,临床中药学。E-mail：zhangbing6@263.net
作者简介:张丹,女,在读博士,中药药物警戒与合理用药。
基金资助:
中国毒理学会临床毒理专项课题(CST2020CT501); 国家自然科学基金资助项目( 81874349); 国家中医药管理局-国家中医药领军人才支持计划“岐黄学者”项目(10400633210004); 第三批国家高层次人才特殊支持计划（万人计划）教学名师项目

Drug Risk Communication among Drug Regulatory Agencies in the European Union, the United States and Asia

ZHANG Dan^1,2, LYU Jintao^1,2, SONG Haibo³, ZHANG Bing^1,2,*, JIN Yongnan⁴, SA Rina^1,5, ZHANG Xiaomeng^1,2, LIN Zhijian^1,2

¹School of Chinese Pharmacy, Beijing University of Chinese Medicine, Beijing 102488, China;
²Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China;
³Center for Drug Reevaluation, Key Laboratory for Research and Evaluation of Pharmacovigilance, NMPA, Beijing 100022, China;
⁴Affiliated Hospital of Yanbian University, Yanji Jilin 133000, China;
⁵Department of Pharmacy, Gansu Provincial Hospital, Lanzhou Gansu 730000, China

Received:2020-08-19 Online:2021-09-15 Published:2021-09-18

摘要/Abstract

摘要： 目的分析亚洲国家药品监管机构开展药品风险沟通的现状,对比欧美国家相关内容与形式,为构建我国药品风险沟通模式提供参考。方法查阅国内外文献,检索亚洲各国药品风险沟通相关的法律法规及指南规范,浏览亚洲各国药品监管机构官方网站等,了解相关机构设置、沟通渠道、发布内容、开展形式等,同时对比欧美药品风险沟通情况。结果欧美国家及地区的药品风险沟通体系较为完善;东亚及东南亚一些国家已经意识到药品风险沟通的重要性,构建了较为及时、有效的风险沟通模式。结论建议我国进一步加强药品风险沟通体系构建,保障人民安全合理用药。

关键词: 药品安全, 风险沟通, 欧美, 亚洲国家

Abstract: Objective To provide reference for the establishment of modes of drug risk communication in China by analyzing the current ways of drug risk communication in Asian countries, and by comparing the related contents and forms in China with those of the European Union and the United States. Methods By reviewing domestic and foreign literature, retrieving the guidelines, specifications, laws and regulations related to drug risk communication in Asia, browsing the official websites of drug regulatory authorities and other websites in Asia, information on related institutions, laws and regulations, communication channels, information released, and ways of development was harvested. Results The system of drug risk communication in Europe and the United States was relatively perfect. Some countries in East Asia and Southeast Asia became aware of the importance of drug risk communication and constructed effective modes of drug risk communication. Conclusion The construction of drug risk communication systems Could be strengthened to guarantee safe and rational drug use.

Key words: drug safety, risk communication, Europe and America, Asian countries

中图分类号:

R951

张丹, 吕锦涛, 宋海波, 张冰, 金勇男, 萨日娜, 张晓朦, 林志健. 欧美与亚洲国家药品监管机构开展药品风险沟通的研究[J]. 中国药物警戒, 2021, 18(9): 845-849.

ZHANG Dan, LYU Jintao, SONG Haibo, ZHANG Bing, JIN Yongnan, SA Rina, ZHANG Xiaomeng, LIN Zhijian. Drug Risk Communication among Drug Regulatory Agencies in the European Union, the United States and Asia[J]. Chinese Journal of Pharmacovigilance, 2021, 18(9): 845-849.

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欧美与亚洲国家药品监管机构开展药品风险沟通的研究

Drug Risk Communication among Drug Regulatory Agencies in the European Union, the United States and Asia

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