Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions

doi:10.19803/j.1672-8629.2019.11.03

Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (11): 654-661.
DOI: 10.19803/j.1672-8629.2019.11.03

Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions

WANG Dan¹, LI Xinling¹, DONG Duo¹, XIONG Weiyi¹, LIU Cuili¹, ZHU Lan¹, GENG Fengying², LIAO Jianbo², YANG Yueming², LAN Shan³, LV Xiaoqin⁴, WANG Tongchun⁵, ZHAO Xia⁶, WANG Wen⁷

1 China National Center for ADR Monitoring , Beijing 100022, China;
2 Liaoning Inspection, Examination & Certification Centre, Shenyang Liaoning 110036, China;;
3 Sichuan Center for ADR Monitoring, Chengdu Sichuan 610017, China;
4 Zhejiang Center for ADR Monitoring, Hangzhou Zhejiang 310012, China;
5 Shanghai Monitoring Center For Drug and Medical Device Adverse Reactions Shanghai 200040, China;
6 Wuxi ADR Monitoring Center, Wuxi Jiangsu 214000, China;
7 Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China

Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

Abstract

Abstract: Objective To investigate the status quo of and existing problems with ADR monitoring in the pharmaceutical industry in China, so as to propose measures to improve the ADR reporting ability of manufacturers.Methods Personnel interviews and questionnaires were used. Personnel interviews were conducted in the form of symposiums and on-the-spot investigation, using qualitative analysis Method. Questionnaire surveys were conducted among more than 1 000 manufacturers in 16 provinces, using qualitative analysis Method.Results There were many problems with the construction of ADR monitoring systems as well as with the collection, reporting, analysis and evaluation, and control of ADRs by drug manufacturers. Technical supervision and administrative supervision needed to be improved.Conclusion Drug manufacturers, ADR monitoring centers and drug regulatory authorities should implement the Notice of the NMPA on Direct Reporting Adverse Reactions by MAHs to the letter so as to improve the awareness of safety and the level of ADR monitoring in the pharmaceutical industry as a whole.

Key words: ADR monitoring, ADR Direct Reporting System, investigation and study

CLC Number:

R994.11

WANG Dan, LI Xinling, DONG Duo, XIONG Weiyi, LIU Cuili, ZHU Lan, GENG Fengying, LIAO Jianbo, YANG Yueming, LAN Shan, LV Xiaoqin, WANG Tongchun, ZHAO Xia, WANG Wen. Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions[J]. Chinese Journal of Pharmacovigilance, 2019, 16(11): 654-661.

References

[1] 国家药品监督管理局. 关于发布国家药品不良反应监测年度报告(2017年)的公告(2018年第3号)[EB/OL]. (2018-04-10)[ 2019-04-21]. 4-10)[ 2019-04-21]. . 4-10)[ 2019-04-21]. http://www.nmpa.gov.cn/WS04 CL2050/227761.html.
[2] 国家药品监督管理局. 关于药品上市许可持有人直接报告不良反应事宜的公告(2018年第66号)[EB/OL]. (2018-09-30)[2019-04-21]. http://www.nmpa.gov.cn/WS04/CL2093/331214.html.
[3] 卫生部. 药品不良反应报告和监测管理办法(卫生部令第81号)[EB/OL]. (2011-05-04)[2019-04-21]. http://www.nhc.gov.cn/fzs/s3576/201105/ac4ab24c135a43379f2af1694457f65e.shtml.
[4] 卫生部. 《药品生产质量管理规范(2010年修订)》(卫生部令第79号)[EB/OL]. (2011-01-17)[2019-04-21]. http://www.nhc.gov.cn/wjw/bmgz/201102/e1783dd3c9684f0cb875d71170a96d17.shtml.
[5] 国家药品监督管理局.《关于药品上市许可持有人直接报告不良反应事宜的公告》政策解读[EB/OL].(2018-09-30)[2019-04-19]. http://www.nmpa.gov.cn/WS04/CL2200/331215.html.
[6] 国家药品监督管理局. 关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号)[EB/OL].(2018-01-25)[2019-04-19]. http://www.nmpa.gov.cn/WS04/CL2093/229313.html.
[7] 国家药品监督管理局. 关于发布个例药品不良反应收集和报告指导原则的通告(2018年第131号)[EB/OL]. (2018-12-19) [2019-04-19]. http://www.nmpa.gov.cn/WS04/CL2138/334011.html.
[8] 赵霞, 冷美玲,王朋, 等. 我国药品生产企业从医疗机构收集药品不良反应信息的现状调查及对策研究[J].中国药物警戒, 2018, 15(11):652-657.
[9] EMA. Good pharmacovigilance practices[EB/OL].[2019-04-27]. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices#final-gvp-product--or-population-specific-considerations-section.
[10] 国家食品药品监督管理总局. 关于印发药品不良反应报告和监测检查指南(试行)的通知(食药监药化监〔2015〕78号)[EB/OL]. (2015-07-02)[2019-04-19] . http://www.nmpa.gov.cn/WS04/CL2196/324118.html.

Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions

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