Research on Construction of Pharmacovigilance System for Marketing Authorization Holders in China

Abstract

Objective To provide suggestions for helping marketing authorization holders (MAHs) to develop an effective and compliant pharmacovigilance system. Methods The construction strategies of pharmacovigilance system of the multinational pharmaceutical companies were analyzed based on the requirements of regulations and laws. Results and Conclusion There are some gaps between local and multinational pharmaceutical companies in the construction of pharmacovigilance system. We can learn from the experience of multinational pharmaceutical companies to improve the pharmacovigilance system, which includes building a sound pharmacovigilance organizational structure, establishing a series of operational system files and cultivating professional talents. MAHs of China should improve the structure of enterprise pharmacovigilance system. Besides, members of Drug Safety Committee should be department managers with higher position so that they can fulfil the responsibilities of risk assessment. If MAHs possess a large variety and quantity of products, a Drug Safety Committee should be established to ensure the timely discovery of risks. In addition, MAHs should pay attention to the implementation of related regulations and laws on pharmacovigilance and establish compliant, effective and operatable files combing with the actual operation of pharmacovigilance system. Finally, MAHs should introduce and train pharmacovigilance talents, and hire pharmacovigilance experts as consultants to solve the problem of talent shortage.

Keywords

marketing authorization holder (MAH) / pharmacovigilance system / good pharmacovigilance practice

References

[1] NMPA. Drug Administration Law of the People’s Republic of China[EB/OL]. (2019-08-27)[2022-10-08]. https://www.nmpa.gov.cn/zhuanti/ztypglf/ypglfzyxx/20190827083801685.html.

[2] NMPA. NMPA Announcement on Issuing Good Pharmacovigilance Practices (No.65 of 2021)[EB/OL].(2021-05-13)[2022-10-08]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20210513151827179.html.

[3] Center for Drug Reevaluation, NMPA. Management Measures for the Reporting and Monitoring of Adverse Drug Reactions[EB/OL]. (2022-07-11)[2022-10-08]. https://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_bmgz/201702/t20170221_40428.html.

[4] NMPA. The General Offices of the Communist Party of China (CPC) Central Committee and the State Council issued the “Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging the Innovation of Medicines and Medical Devices”[EB/OL].(2017-10-09)[2022-10-08]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20171009164201907.html.

[5] NMPA. Notice of the NMPA on the Issuance of the Guideline for Pharmacovigilance Inspection[EB/OL].(2022-04-15)[2022-10-08]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20220415102743184.html.

[6] Zhang Yijing. Thoughts on how to implement good pharmacovigilance practices in China from a global pharmaceutical industry perspective[J]. Chinese Journal of Pharmacovigilance, 2021, 18 (6): 507-509.

[7] 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)[2022-10-08]. http://www.cde.org.cn/ichWeb/guideIch/toGuideIch/3/0.

[8] Fang Yuemin, Hu Jun. Problems and countermeasures on pharmacovigilance system of 15 marketing authorization holders in Shanghai[J]. China Pharmacy, 2022, 33 (5): 519-523.

[9] Lin Lijun, Lin Kai, Miao Huiqing. Analysis and discussion on current status of pharmacovigilance system of marketing authorization holder in Hainan Province[J]. Chinese Journal of Drug Application and Monitoring, 2021, 18 (1): 52-55.

[10] Guo Shasha, Liu Hongxing, Wang Bing, et al. Current situation of marketing authorization holders pharmacovigilance working in Hebei Province[J]. Chinese Journal of Medicinal Guide, 2021, 18 (23): 152-155+164.

[11] Liu Ying, Xie Yan, Song Ligang. Current status and discussion on post-marketing pharmacovigilance in marketing authorization holder (MAH) of Tianjin[J]. Tianjin Pharmacy, 2021, 33 (1): 11-14.

[12] Shen Mengqiu, Li Ming, Wang Jiayu, et al. Sampling investigation of current situation of pharmacovigilance in pharmaceutical manufacturers in Jiangsu Province[J]. Chinese Journal of Pharmacovigilance, 2021, 18 (2): 133-137+144.

[13] Wan Bangxi, Xiao Liang, Xu Juping. Practice of pharmacovigilance courses provision at medical and pharmaceutical college[J]. Chinese Journal of Pharmacovigilance, 2018, 15 (1): 32-35.