Overview of Implementation of E2B (R3) Guidelines by ICH Founding Regulatory Members

doi:10.19803/j.1672-8629.2019.10.05

Abstract

Abstract: Objective To introduce the implementation of E2B（R3） guidelines by regulatory agencies in Europe, the United States, Japan and other countries in order to provide reference for the implementation of E2B（R3） in China. Methods The current implementation of E2B in ICH founding regulatory agency member states was outlined by analying adverse reaction databases, guidelines and report submission methods in Europe, the United States, Japan and other countries. Results & Conclusion Developed countries, such as Europe, the United States and Japan, have accumulated much experience after many years of implementation, which can facilitate the implementation of E2B（R3） in China.

Key words: E2B (R3), ICSR, regional guideline, system

CLC Number:

R951

LIU Hongliang, ZHENG Mingjie, LI Xinling, WANG Qing, HOU Yongfang. Overview of Implementation of E2B (R3) Guidelines by ICH Founding Regulatory Members[J]. Chinese Journal of Pharmacovigilance, 2019, 16(10): 594-596.

References

[1] 侯永芳,董铎,熊玮仪,等. 个例安全性报告E2B规范的发展[J]. 中国药物警戒,2018,15(3): 144-146.
[2] 叶小飞,郭晓晶,赵璐,等. 个例安全性报告规范(ICH E2B)简介及应用[J]. 中国药物警戒,2012,9(3): 149-151.
[3] 董铎,吴桂芝,王丹,等. 美国药品上市后监测体系对我国落实企业报告责任的启示[J].中国药物警戒,2017,14(10): 607-610.
[4] FDA. User Guide[EB/OL].(2018-03-22) [2019-06-10].https://www.fda. gov/ForIndustry/ ElectronicSubmissionsGateway /About ESG/ucm33435 9.htm.
[5] FDA. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide -Data Elements and Message Specification; and Appendix to the Implementation Guide - Backwards and Forwards Compati -bility[EB/OL].(2018-11-07)[2019-06-10]. http://www.fda. gov/Drugs /GuidanceComplianceRegulatoryInformation/Guidances/ucm274966.htm.
[6] EMA. EudraVigilance:how to register[EB/OL].(2018-11-07)[2019- 07-31]. http://www.ema. europa .eu/ema/index.jsp?curl=pages/regulation/general/general_content_000687.jsp.
[7] EMA. Implementing ISO ICSR/ICH E2B (R3):Key Changes for pharmaco -vigilance[EB/OL].(2014- 12-04)[2019-07-31]. https:// www.ema.europa.eu/en /documents/presentation/presentation-implementing-iso-icsr/ich-e2br3-key-changes-pharmacovigilance-training-module-phv-m2a_en.pdf.
[8] EMA. EudraVigilance: electronic reporting[EB/OL].(2018-11- 07)[2019-06-10]. https://www. ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-electronic-reporting.
[9] EMA. EudraVigilance[EB/OL].(2018-11-07)[2019-06-10]. http:// www.ema.europa.eu/ema /index.jsp?curl=pages/regulation/general/general_content_000679jsp&mid=WC0b01ac05800250b5.
[10] YukioTakashi. Practical Use of the Open Japanese Adverse Drug Event Report Database (JADER)[J]. Jpn J Pharmacoepidemiol, 2014,19(1):14-22.
[11] Masakazu Fujiwara, Yohei Kawasaki, Hiroshi Yamada,et al.A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis[J]. PLoS ONE,2016,11(4):1-8.

[1]	MA Meiying, ZHAO Xiaopei, ZHANG Mengyao, HU Yilin. Drug traceability coding system in China [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 167-172.
[2]	LI Jiaxin, LIU Huimin, QIAN Wenxiu, MA Ning, SONG Lili, LI Yubo. Nephrotoxic effects and usage of traditional Chinese medicines based on the Traditional Chinese Medicine Systems Toxicology Database [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 173-180.
[3]	XU Weijia, PENG Qi, HUANG Haiyu, ZHANG Leijiao, XIAO Hua, WU Xue. 285 cases of adverse drug reaction related to new antineoplastic drugs [J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 199-203.
[4]	BAI Zhaofang, ZHAN Xiaoyan, YAO Qing, CHEN Simin, ZHAO Xu, XIAO Xiaohe. Theoretical innovation and technological breakthroughs in the safety evaluation of traditional Chinese medicine: disease-syndrome-based toxicology [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 6-14.
[5]	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.
[6]	LIANG Dong, LUO Li, CHENG Junxiang. Adverse reactions caused by levetiracetam [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1054-1059.
[7]	SHI Xiangfen, SUN Zhiyong, ZHANG Xufeng, LU Xiaojing, DU Shuzhang, ZHANG Xiaojian. Whole process management of narcotic drugs and psychotropic drugs based on intelligent information management system [J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 899-903.
[8]	ZHANG Lei, LYU Jian, XIE Yanming. Efficacy and safety of Houpupaiqi Mixture in the treatment of postoperative lieus: a Meta-analysis [J]. Chinese Journal of Pharmacovigilance, 2023, 20(7): 799-806.
[9]	. Annual report of national adverse drug reaction monitoring (2022) [J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 712-719.
[10]	YUE Xiaolin, LU Song, ZHANG Lan. Research in the construction of comprehensive evaluation systems of drugs in China [J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 530-535.
[11]	CHENG Fengjingming, LYU Jian, XIE Yanming. Efficacy and safety of compound salvia miltiorrhiza spray/aerosol for angina pectoris due to coronary artery disease: a Meta analysis [J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 536-543.
[12]	PENG Miaoxin, WANG Yanqiong, XU Peipei, YANG Yonggong. Analysis of epileptic seizures induced by lenalidomide with high-grade B cell lymphoma [J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 585-587.
[13]	SU Xinxin, LYU Jian, XIE Yanming. Efficacy and safety of Toutongning capsules in the treatment of chronic headache: a Meta-analysis [J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 433-440.
[14]	ZHENG Yujing, ZHAO Zinan, JIN Pengfei, ZHAO Fei, HU Xin, ZHANG Yatong. Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system [J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 441-443.
[15]	BAO Lei, GENG Zihan, GUO Shanshan, YAO Rongmei, SUN Jing, CUI Xiaolan. Effect of Reyanning Heji on animal models of respiratory infectious inflammation [J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 241-247.