我国药物临床试验期间可疑且非预期严重不良反应快速报告的常见问题及建议

doi:10.19803/j.1672-8629.2022.02.13

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (2): 176-179.
DOI: 10.19803/j.1672-8629.2022.02.13

我国药物临床试验期间可疑且非预期严重不良反应快速报告的常见问题及建议

刘敏, 裴小静, 王海学^*

国家药品监督管理局药品审评中心,北京 100028

收稿日期:2021-05-06 出版日期:2022-02-15 发布日期:2022-02-15
通讯作者: ^*王海学,男,博士,主任药师,临床试验管理。E-mail：wanghx@cde.org.com
作者简介:刘敏,女,硕士,主管药师,临床试验管理。

Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China

LIU Min, PEI Xiaojing, WANG Haixue^*

Center for Drug Evaluation National Medical Products Administration, Beijing 102488, China

Received:2021-05-06 Online:2022-02-15 Published:2022-02-15

摘要/Abstract

摘要： 目的为提高药物临床试验期间可疑且非预期严重不良反应快速报告的质量。方法以近2年监管机构收到的安全性快速报告问题为基础,结合目前国内外快速报告的相关要求及现状,筛选出共性问题。结果对我国药物临床试验期间可疑且非预期严重不良反应快速报告的几点共性问题提出分析和建议。结论从事药物临床试验期间快速报告工作的相关人员应准确理解国内外药物警戒相关的指南、法规等要求,更好地保护好受试者安全。

关键词: 临床试验, 快速报告, 常见问题, 安全性, 可疑且非预期严重不良反应

Abstract: Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects.

Key words: clinical trials, expedited reporting, common problems, safety, suspected and unexpected serious adverse reactions

中图分类号:

R95R994.11

刘敏, 裴小静, 王海学. 我国药物临床试验期间可疑且非预期严重不良反应快速报告的常见问题及建议[J]. 中国药物警戒, 2022, 19(2): 176-179.

LIU Min, PEI Xiaojing, WANG Haixue. Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 176-179.

参考文献

[1] National Medical Products Administration. Notice on the application of international conference on harmonization tier 2 guidelines.(No.10,2018)[EB/OL].(2018-01-25)[2021-02-25]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20180125175101686.html.
[2] Center of Drug Evaluation, NMPA. Notice on the release of standards and procedures for expedited reporting of safety data during drug clinical trials [EB/OL].(2018-04-27)[2021-02-25]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=90755b9d6035c1b4.
[3] Center of Drug Evaluation, NMPA. Notice on the release of the faq on expedited reporting of safety data during drug clinical trials (Version 1.0) [EB/OL].(2019-04-11)[2021-02-25]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=c84bb18fb9817da1.
[4] National Medical Products Administration.Notice on the Implementation of archival management of chemical drug bioequivalence(No.257,2015) [EB/OL].(2015-12-01)[2021-02-25]. https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20151201214701277.html.
[5] State Administration for Market Regulation. Drug registration regulation(No.27) [EB/OL].(2020-04-02)[2021-02-25]. http://www.ipraction.gov.cn/article/zcfg/bwgz/202004/307960.html.
[6] Center of Drug Evaluation, NMPA. Notice on the opening of the column of "submission of safety-related reports during development" on the website of the CDE[EB/OL].(2019-04-26)[2021-02-25]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=ec45b68589a1ccf7.
[7] National Medical Products Administration. National Medical Products Administration & National Health Commission of the People’s Republic of China. Notice on the good clinical practice(No.57,2020)[EB/OL].(2020-04-26)[2021-05-06]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200426162401243.html.
[8] SFL SN.One of the rapid reporting criteria:anticipatory determin-ation[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2009, 6(2): 126-128.
[9] ICH. ICHE2A: Clinical safety data management: definitions and standards for expedited reporting[EB/OL].(1994-10-27)[2021-02-25]. http://www.cde.org.cn/ichWeb/guideIch/toGuideIch/3/0.
[10] ICH. ICH E2B(R3): Implementation guide for electronic transmission of individual case safety reports (icsrs) e2b(r3)data elements and message specification[EB/OL].(2016-11-10)[2021-02-25]. http://www.cde.org.cn/ichWeb/guideIch/toGuideIch/3/0.
[11] National Medical Products Administration. Notice on the release of the implementation of individual case safety reporting e2b(r3) area guidelines[EB/OL].(2019-11-22)[2021-02-25]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20191122091301498.html.
[12] CIOMS. Managing safety information from clinical trials: CIOMS VI[J]. Reactions Weekly, 2004, 1011(1): 3-4.
[13] The National People’s Congress of the People’s Republic of China.Drug administration law of the People’s Republic of China[EB/OL].(2019-08-26)[2021-02-25]. http://www.npc.gov.cn/npc/c35500/201908/c6e5dc209f9f4d608523d789ac1a3925.shtml.

[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]	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.
[3]	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.
[4]	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.
[5]	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.
[6]	陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明. 326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析[J]. 中国药物警戒, 2024, 21(1): 107-110.
[7]	马瑞泽, 陈志海. 抗新型冠状病毒的小分子药物最新研究进展[J]. 中国药物警戒, 2023, 20(9): 961-966.
[8]	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.
[9]	沈艳杰, 吴奕卿. 临床试验期间不良事件管理的实践与思考[J]. 中国药物警戒, 2023, 20(9): 982-986.
[10]	刘文东, 崔欢欢, 王晓晗, 苏娴, 王海学. 我国儿童用药临床试验期间药物警戒监管体系现状及思考[J]. 中国药物警戒, 2023, 20(9): 1002-1006.
[11]	刘倩, 胡晶, 李博, 杨小静. 荆花胃康胶丸联合四联疗法治疗幽门螺旋杆菌相关性胃炎的系统评价及Meta分析[J]. 中国药物警戒, 2023, 20(9): 1039-1045.
[12]	于洪礼, 于冬梅, 肖爱丽, 朱兰, 宋海波. 清开灵口服制剂安全性风险分析[J]. 中国药物警戒, 2023, 20(9): 1046-1048.
[13]	李婧, 徐烨, 刘冉佳, 潘晨, 崔向丽. 新型冠状病毒感染患者使用托珠单抗后发生不良反应的病例分析[J]. 中国药物警戒, 2023, 20(9): 1049-1053.
[14]	地力乎马·地力木拉提, 石伟, 王伽伯, 高源. 基于毒/效记载演变探讨补骨脂的安全应用研究进展[J]. 中国药物警戒, 2023, 20(8): 939-945.
[15]	李亚梅, 水荣. 托法替尼治疗幼年特发性关节炎研究进展[J]. 中国药物警戒, 2023, 20(8): 956-960.

我国药物临床试验期间可疑且非预期严重不良反应快速报告的常见问题及建议

Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China

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