个例药品不良反应报告管理浅析与思考

doi:10.19803/j.1672-8629.20230264

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (9): 975-977.
DOI: 10.19803/j.1672-8629.20230264

• 药物警戒质量管理规范实践专栏 • 上一篇下一篇

个例药品不良反应报告管理浅析与思考

里筱竹¹, 王蔷², 逄瑜³, 张轶菁^1,*

¹百济神州（北京）生物科技有限公司,北京 100022;
²百时美施贵宝（中国）投资有限公司,上海 200040;
³荣昌生物制药（烟台）有限公司,北京 100020

收稿日期:2023-05-09 出版日期:2023-09-15 发布日期:2023-09-14
通讯作者: ^*张轶菁,女,硕士,药物警戒。E-mail: yijing.zhang@beigene.com
作者简介:里筱竹,女,硕士,药物警戒。

Management of individual adverse drug reaction reports

LI Xiaozhu¹, WANG Qiang², PANG Yu³, ZHANG Yijing^1,*

¹BeiGene, Ltd. (BeiGene) c/o Beijing, Inc., Beijing 100022, China;
²Bristol-Myers Squibb (China) Investment Co., Ltd., Shanghai 200240, China;
³RemeGen Co., Ltd., Beijing 100020, China

Received:2023-05-09 Online:2023-09-15 Published:2023-09-14

摘要/Abstract

摘要： 目的结合国内外药物警戒法规对个例药品不良反应报告（简称“个例报告”）管理工作各环节要点进行总结和梳理,为药品上市许可持有人（简称“持有人”）开展个例报告管理工作提供参考。方法通过查阅相关文献及国内外法规,对个例报告管理各环节的操作流程进行全面介绍,结合实际经验讨论操作过程中个例报告管理工作需要关注的问题。结果与结论 个例报告是持有人开展药物警戒工作的基础,持有人应按照相关规定,合规开展个例报告的收集、处理及递交工作。

关键词: 药物警戒, 药品上市许可持有人, 药品不良反应, 个例药品不良反应报告, 安全性, 药物警戒质量管理规范

Abstract: Objective To summarize and analyze the key points of ways in which individual case safety reports (ICSRs) are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders (MAHs) in handling ICSRs. Methods Based on a review of related literature and regulations at home and abroad, the whole process of ICSR management was introduced. Speaking from experience, we discussed the problems that were worthy of attention in the course of ICSR management. Results and Conclusion ICSRs underline pharmacovigilance by MAHs, who should collect, process, and submit ICSRs in accordance with related laws and regulations.

Key words: pharmacovigilance, MAHs, adverse drug reactions, individual case safety reports(ICSRs), safety, Good Pharmacovigilance Practice

中图分类号:

R954

里筱竹, 王蔷, 逄瑜, 张轶菁. 个例药品不良反应报告管理浅析与思考[J]. 中国药物警戒, 2023, 20(9): 975-977.

LI Xiaozhu, WANG Qiang, PANG Yu, ZHANG Yijing. Management of individual adverse drug reaction reports[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 975-977.

参考文献

[1] National Medical Products Administration (NMPA). Drug Administration Law of the People's Republic of China (中华人民共和国药品管理法)[EB/OL].(2019-08-27)[2023-05-01]. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html.
[2] The Xinhua News Agency. The preliminary investigation for incidence of “XINFU”: The approved manufacturing procedure was not followed by An Hui Hua Yuan[EB/OL]. (2006-08-10)[2023-05-01]. http://www.gov.cn/jrzg/2006-08/10/content_359484.htm.
[3] ICH harmonised tripartite guideline. ICH E2D post-approval safety data management: definitions and standards for expedited reporting[EB/OL]. (2003-11-12)[2023-05-01]. https://www.ich.org/page/efficacy-guidelines.
[4] Ministry of Health. Administration of Adverse Drug Reaction (ADR) Reporting and Monitoring (药品不良反应报告和监测管理办法)[EB/OL].(2011-07-01)[2023-05-01]. https://www.nmpa.gov.cn/yaopin/ypfgwj/ypfgbmgzh/20110504162501325.html.
[5] National Medical Products Administration (NMPA). NMPA Announcement No.2021/65: Good Pharmacovigilance Practice (GVP) of Drugs (国家药监局关于发布《药物警戒质量管理规范》的公告2021年第65号)[EB/OL].(2021-05-13)[2023-05-01]. https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20210513151827179.html.
[6] National Medical Products Administration (NMPA). Guidelines for Collection and Reporting of Individual Adverse Drug Reactions (个例药品不良反应收集和报告指导原则)[EB/OL]. (2018-12-21) [2023-05-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20181221172901438.html.
[7] European Medicines Healthy. Guideline on good pharmacovigilance practices (GVP) Module VI-Collection, management and submission of reports of suspected adverse reactions to medicinal products[EB/OL]. (2017-11-22)[2023-05-01]. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices.
[8] Food and Drug Administration. Federal Food, Drug and Cosmetic Act, “FD&CA”[EB/OL]. (2018-03-29)[2023-05-01]. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act.
[9] Pharmaceuticals and Medical Devices Agency. Pharmaceutical and Medical Device Act[EB/OL]. (2005-03-17)[2023-05-01]. https://www.pmda.go.jp/safety/reports/mah/0024.html#1.
[10] National Medical Products Administration (NMPA). Instructions for completing form of Adverse drug reaction Report form for marketing authorization holder (draft) (上市许可持有人药品不良反应报告表(试行)填表说明)[EB/OL]. (2020-01-08)[2023-05-01]. https://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202001/t20200108_47026.html.
[11] Word Health Organization. Guidance on good data and record management practices[EB/OL]. (2016-09-30)[2023-05-01]. https://www.who.int/publications/m/item/trs-966-annex-5-who-good-data-and-record-management-practices.
[12] National Medical Products Administration (NMPA). Guideline on MedDRA Coding for MAH (药品上市许可持有人MedDRA编码指南)[EB/OL]. (2022-05-06)[2023-05-01]. https://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202205/t20220506_49658.html.
[13] Considerations for MedDRA terms selections (MedDRA术语选择考虑要点)[EB/OL]. (2022-04-22)[2023-05-01]. https://admin.meddra.org/sites/default/files/guidance/file/000714_termselptc_r4_22_mar2022_chinese_0.pdf.
[14] ICH harmonised tripartite guideline. ICH E2A. ICH harmonised tripartite guideline. ICH E2A clinical safety data management: definitions and standards for expedited reporting[EB/OL].(1994-10-27)[2023-05-01]. https://www.ich.org/page/efficacy-guidelines.
[15] Food and Drug Administration. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL]. (2018-08-24)[2023-05-01]. https://www.fda.gov/files/drugs/published/Good-Pharmacovigilance-Practices-and-Pharmacoepidemiologic-Assessment-March-2005.pdf.
[16] Navitas Life Sciences.PVConnect benchmark overview 2020[R]. Confidential - Property of Navitas Life Sciences, 2020.
[17] National Medical Products Administration (NMPA). Pharmacovigilance Annual Report (2022) (国家药品不良反应监测年度报告2022年)[EB/OL]. (2023-03-24)[2023-05-01]. https://www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202303/t20230324_50019.html.

个例药品不良反应报告管理浅析与思考

Management of individual adverse drug reaction reports

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	贾茵茵, 张财树, 周颖, 刘丽, 耿颖, 魏宁漪, 钮思静, 陈华, 许卉. 吸入制剂微细粒子空气动力学粒径分布评价方法研究[J]. 中国药物警戒, 2024, 21(2): 141-146.
[2]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[3]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[4]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[5]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[6]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[7]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[8]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[9]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[10]	柏兆方, 湛小燕, 姚清, 陈思敏, 赵旭, 肖小河. 中药安全性评价理论创新与技术突破：病证毒理学[J]. 中国药物警戒, 2024, 21(1): 6-14.
[11]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[12]	方志娥, 李承贤, 柏兆方, 赵旭, 王伽伯, 肖小河. 马兜铃酸致肝癌的客观性研究与思考[J]. 中国药物警戒, 2024, 21(1): 20-24.
[13]	熊玮仪, 任经天. 抗肿瘤药说明书安全性信息上市后修订的考虑要点[J]. 中国药物警戒, 2024, 21(1): 94-97.
[14]	刘敏, 陈艳, 刘文东, 王海学. 药物临床试验期间安全性数据快速报告的更新与思考[J]. 中国药物警戒, 2024, 21(1): 98-101.
[15]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.