Progress in Implementation of ICH M1 in Post-marketing Monitoring of Drugs in China

doi:10.19803/j.1672-8629.2021.08.13

Abstract

Abstract: Objective To report the progress in the implementation of MedDRA during the post-marketing monitoring of drugs in China in order to provide reference for complete implementation of MedDRA. Methods MedDRA was outlined. The problems with and challenges to the implementation and transformation of MedDRA were discussed. Ways to implement MedDRA were recommended. Results and Conclusion MedDRA is a medical term widely used in the field of global drug regulation. The implementation of MedDRA is conducive to the sharing and exchange of post-marketing monitoring data on drugs, but has to be steadily advanced in light of the actual situation in China.

Key words: post-marketing monitoring of drugs, MedDRA, ICH

CLC Number:

R951

TIAN Chunhua, LIU Wei, LIU Cuili, HOU Yongfang, WANG Dan. Progress in Implementation of ICH M1 in Post-marketing Monitoring of Drugs in China[J]. Chinese Journal of Pharmacovigilance, 2021, 18(8): 763-765.

References

[1] NMPA. China Food and Drug Administration (CFDA) became a member of the ICH[EB/OL]. (2017-06-22)[2020-09-01]. https://www.nmpa.gov.cn/zwgk/xwfb/20170622153001224.html.
[2] NMPA. National Medical Products Administration was elected as a member of the Administrative Committee of the ICH [EB/OL]. (2018-06-07)[2020-09-01]. https://www.nmpa.gov.cn/yaowen/ypjgyw/20180607144001273.html.
[3] NMPA. Notice on the Application of the Second-level Guidelines of the ICH (No.10 of 2018) [EB/OL]. (2018-01-25)[2020-09-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20180125175101686.html.
[4] Wu GZ, Tian CH, Wang D, et al.Use of WHOART and MedDRA in adverse reaction monitoring[J]. Chinese Journal of Pharmac-ovigilance(中国药物警戒), 2010, 7(2): 81-85.
[5] Liu J,Xie YM,Gai GZ, et al.Application analysis of adverse drug reaction terminology WHOART and MedDRA[J].China Journal of Chinese Material Medica(中国中药杂志), 2015, 40(24); 4728-4733.
[6] Lin WX, Ye XF, Yao HX, et al.Analysis of the current adverse drug reaction terminologies[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2009, 6(12): 713-716.
[7] Center for Drug Reevaluation, NMPA. Notice on the issuance of the national adverse drug reaction monitoring annual report (2019) [EB/OL].(2020-04-20)[2020-09-01]. http://www.cdr-adr.org.cn/drug_1/aqjs_1/drug_aqjs_sjbg/202004/t20200420_47318.html.
[8] MedDRA. Subscription rates[EB/OL].[2020-09-01]. https://www.meddra.org/subscription-rates.
[9] Center for Drug Reevaluation, NMPA. Notification of the publication of guidelines for the implementation of E2B(R3) area for individual case safety reporting[EB/OL]. (2019-11-22)[2020-09-01]. http://www.cdr-adr.org.cn/drug_1/ICHzd_1/ICH_E2B/201911/t20191122_46834.html.
[10] Center for Drug Reevaluation, NMPA. Notification of commissioning of E2B (R3) electronic transmission system[EB/OL]. (2019-12-31)[2020-09-01]. http://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/201912/t20191231_47006.html.
[11] Ma DH, Liu HL, Wang D, et al.Study on applicability of ICH guideline M1 (I) mapping feasibility study of national adverse drug reaction terminology[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(6): 329-332.
[12] Hou YF, Tian CH, Liu HL, et al.Study on applicability of ICH guideline M1 (II) mapping practice of national adverse drug reaction terminology[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(6): 333-337.

[1]	CHEN Chenxin, ZHANG Pengpeng, LIU Yongmei, YE Xiaofei, HE Jia. Combination of zero-inflated model and Dirichlet process in detection of adverse reaction signals during post-marketing surveillance [J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 651-654.
[2]	TIAN Chunhua, WU Guizhi. Implementation of periodic benefit risk evaluation reports in China [J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1382-1384.
[3]	LIU Caiping, CHAO Bao, FENG Yuanzhou, SUN Lan, LUO Yuan, YANG Jingfeng, DONG Wu, WANG Yongan, LI Yueting, ZHAO Baoquan. Establishment of transgenic zebrafish model regulated by nr1h4 and related studies [J]. Chinese Journal of Pharmacovigilance, 2022, 19(8): 873-880.
[4]	ZHANG Qiang, DU Pengcheng, MAN Chunrui, SUN Qian. Network pharmacology of protection against angina pectoris by Ginkgo Biloba [J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 158-163.
[5]	YANG Xiaolu, CAO Shan, XIONG Bo, QIN Zhen, XIA Yun, QU Hong. One case of serious liver injury induced by Xiaojin tablets [J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 213-216.
[6]	Anna C Zhao-Wong, ZHU Lilin. An introduction to the Medical Dictionary for Regulatory Activities and its use [J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 74-78.
[7]	SUN Qian, CHEN Hong, GUO Xinxin, LIU Shengwei, LIAO Yuan, JIA Lingling. Network Pharmacology of Luteolin Protecting against Cerebral Ischemia [J]. Chinese Journal of Pharmacovigilance, 2021, 18(8): 760-762.
[8]	LIU Cuili, TIAN Chuanhua, XIA Dongsheng, ZHU Lan, LIU Hongliang, SHEN Changhui, QI Yan, WANG Tao. Considerations about MedDRA Coding in Adverse Drug Reaction Reports [J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1055-1057.
[9]	YANG Yue. Implementation of Pharmacovigilance System in Drug Administration Law and Application of ICH E2 Guideline [J]. Chinese Journal of Pharmacovigilance, 2020, 17(2): 65-71.
[10]	LIU Lei, ZHANG Qiongling, WANG Jiyong, DING Shilan, YOU Yun, XIAO Suping. Bioassay on Aquatic Extract of Processed Radix Aconiti Carmichaeli [J]. Chinese Journal of Pharmacovigilance, 2020, 17(2): 75-80.
[11]	HOU Yongfang, TIAN Chunhua, LIU Hongliang, LIU Cuili, LI Ming, WANG Xinmin. Study on Applicability of ICH Guideline M1 Mapping Practice of National Adverse Drug Reaction Terminology [J]. Chinese Journal of Pharmacovigilance, 2019, 16(6): 333-337.
[12]	MA Danhua, LIU Hongliang, WANG Dan, LI Ming, TIAN Chunhua. Study on Applicability of ICH Guideline M1 Mapping Feasibility of National Adverse Drug Reaction Terminology [J]. Chinese Journal of Pharmacovigilance, 2019, 16(6): 329-332.
[13]	HOU Yong-fang, DONG Duo, XIONG Wei-yi, LI Lan, LIU Hong-liang, LIU Rui, WAN Bang-xi. Developement of ICSR E2B Guideline [J]. Chinese Journal of Pharmacovigilance, 2018, 15(3): 144-146.
[14]	ZHANG Xue-mei, GUO Jia-dong, FENG Bian-ling, YANG Shi-min. Investigation on Work State of Adverse Drug Reaction Reporting in Some West Provinces [J]. Chinese Journal of Pharmacovigilance, 2015, 12(12): 740-743.
[15]	LI Qing-na,LU Fang,ZHAO Yang,GAO Hong-yang,GAO Rui. A Preliminary Study on Establishing the Set of Terms for Coding Clinical Trials of TCM Based on MedDRA Terminology [J]. Chinese Journal of Pharmacovigilance, 2015, 12(1): 53-55.