文献来源的上市后药品不良反应报告常见问题分析

doi:10.19803/j.1672-8629.2021.12.12

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1155-1158.
DOI: 10.19803/j.1672-8629.2021.12.12

文献来源的上市后药品不良反应报告常见问题分析

朱兰¹, 朱彦², 刘丽红², 邵波¹, 刘红亮¹, 熊玮仪^1,*

¹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;
²中国中医科学院中医药信息研究所,北京100027

收稿日期:2021-08-04 出版日期:2021-12-15 发布日期:2021-12-16
通讯作者: ^*熊玮仪,女,博士,副研究员,流行病学及药品不良反应监测。E-mail：xiongweiyi@cdr-adr.org.cn
作者简介:朱兰,女,硕士,主管药师,药品不良反应监测与评价。
基金资助:
国家重点研发计划课题（2018YFC1707409）; 中国中医科学院基本科研业务费自主选题项目（ZZ150314）

Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature

ZHU Lan¹, ZHU Yan², LIU Lihong², SHAO Bo¹, LIU Hongliang¹, XIONG weiyi^1,*

¹Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
²Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences , Beijing 100022, China

Received:2021-08-04 Online:2021-12-15 Published:2021-12-16

摘要/Abstract

摘要： 目的总结我国文献来源的上市后个例药品不良反应报告常见问题,并提出相关建议,为药品上市许可持有人提供参考。方法列举文献来源的上市后个例药品不良反应报告中的常见实际问题,对照我国药品监管部门2018年来发布的相关文件和指导原则,以及人用药品注册技术要求国际协调会（ICH）E2D指导原则中对来文献来源的上市后个例药品不良反应报告相关要求,分析问题并提出改进建议。结果与结论部分文献来源的不良反应报告的规范性、完整性和及时性等有所欠缺,建议药品上市许可持有人加强相关工作以提高报告质量。

关键词: 药品不良反应, 个例药品不良反应报告, 文献检索

Abstract: Objective To summarize problems with post-marketing adverse drug reaction (ADR) reports collected from literature in China and give related advice to marketing authorization holders (MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed. Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2D guideline. Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance, completeness and timeliness, and MAHs need to make more efforts to improve the quality of such reports.

Key words: adverse drug reaction, individual case safety reports, literature search

中图分类号:

R951

朱兰, 朱彦, 刘丽红, 邵波, 刘红亮, 熊玮仪. 文献来源的上市后药品不良反应报告常见问题分析[J]. 中国药物警戒, 2021, 18(12): 1155-1158.

ZHU Lan, ZHU Yan, LIU Lihong, SHAO Bo, LIU Hongliang, XIONG weiyi. Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1155-1158.

参考文献

[1] NMPA. NMPA announcement on direct reporting of adverse reactions by drug marketing authorization holders (No. 66, 2018) [EB/OL].(2018-09-30)[2021-08-02]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180930174301286.html.
[2] National Center for ADR Monitoring, China. Notice on questions and answers documents for Marketing Authorization Holders directly reporting adverse drug reactions [EB/OL].(2019-02-01)[2021-08-02]. http://www.cdr-adr.org.cn/tzgg_home/201902/t20190201_39656.html.
[3] NMPA. Guideline for collecting and reporting of drug adverse reaction case reports(No. 131, 2018) [EB/OL]. (2018-12-21)[2021-08-02].https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20181221172901438.html.
[4] NMPA. NMPA announcement on issuing good pharmacovigilance practices (No.65 of2021)[EB/OL].(2021-07-06)[2021-05-13].https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html.
[5] ICH. ICH E2D post-approval safety data management: Definitions and standards for expedited reporting (中文版) [EB/OL].(2019-09-27)[2021-08-02]. http://www.cdr-adr.org.cn/drug_1/ICHzd_1/ICH_E2D/201909/t20190927_36891.html.
[6] ICH. ICH E2D post-approval safety data management: Definitions and standards for expedited reporting[EB/OL].(2003-11-12)[2021-08-02]. https://database.ich.org/sites/default/files/E2D_Guideline.pdf.
[7] National Center for ADR Monitoring, China. Notice on issuing the form and Instructions of adverse drug reactions case reports for MAH [EB/OL].(2020-01-08)[2021-08-02]. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202001/t20200108_47026.html
[8] National Center for ADR Monitoring, China. Notice on issuing the E2B(R3) regional implementation guide for individual case safety reports(ICSRs) [EB/OL].(2019-11-22)[2021-08-02]. http://www.cdr-adr.org.cn/drug_1/ICHzd_1/ICH_E2B/201911/t20191122_46834.html.
[9] ICH. MedDRA term selection: points to consider[EB/OL].(2021-03-01)[2021-08-02]. https://www.meddra.org/how-to-use/support-documentation/chinese?current=true.
[10] NMPA.NMPA announcement on issuing the guide for evaluation the literature of post-approval drug clinical safety (No.77, 2019) [EB/OL].(2019-06-18)[2021-08-02].https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20190618165701432.html.

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文献来源的上市后药品不良反应报告常见问题分析

Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature

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