A National Pharmacovigilance Management System in a New Era

doi:10.19803/j.1672-8629.20240861

Abstract

Abstract: Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry.

Key words: Pharmacovigilance, Risk Management, Management System, Regulation of Drugs, Regulatory Science

CLC Number:

R951
R994.11

YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao. A National Pharmacovigilance Management System in a New Era[J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 276-281.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I3/276

References

[1] XU F. Scientifically Grasping the Innovation of China's Drug Survei-llance System[N/OL].China Pharmaceutical News(中国医药报),(2020-05-18)[2024-05-05].https://bk.cnpharm.com/zgyyb/2020/05/18/310160.html.
[2] WHO. The Importance of Pharmacovigilance(Safety Monitoring of Medicinal Products)[M].Geneva: Word Health Organization, Collabo-rating Centre for International Drug Monitoring, 2002: 1-8.
[3] NMPA. Provisions for Adverse Drug Reaction Reporting and Monitoring [EB/OL] .(2011-05-04)[2024-05-05].https://www. nmpa.gov.cn/.
[4] WANG D, DONG D, TIAN CH.Course of Development of Pharmocov-igilance Systems in China[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2024, 21(7): 735-740.
[5] General Office of the CPC Central Committee, General Office of the State Council. Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceutical and Medical Devices[EB/OL] .(2017-10-08)[2024-12-12] .https://www.gov.cn/zhengce/2017-10/08/content_5230105.htm.
[6] People's Congress. Drug Administration Law of the People's Republic of China[EB/OL].(2019-08-26) [2020-05-20].http://www.npc.gov.cn/englishnpc/c2759/c23934/202012/t20201229_384168.html.
[7] NMPA. Good Pharmacovigilance Practices[EB/OL].(2021-05-07)[2024-05-05].https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20210-513151827179.html.
[8] WANG D, WANG T, XIA XD, et al.Enlightenment of Good Pharmaco-vigilance Practice on the Implementation of Pharmacovigilance System in Enterprises[J].Herald of Medicine(医药导报),2021, 40(10): 1303-1306.
[9] WANG D, REN JT, WU GZ, et al.Significance of Good Pharmacovigilance Practice in the Construction of China Pharmacovigilance System[J].Chinese Journal of Pharmacovigilance(中国药物警戒),2021, 18(6): 501-503.
[10] NMPA. Guideline on Pharmacovigilance Inspections[EB/OL] .(2022- 04-15)[2024-05-05].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20220415102743184.html.
[11] LUO N. The National Medical Products Administration has released the "Guiding Principles for Drug Vigilance Inspection"[N].China Pharmaceutical News(中国医药报),2022-04-18(A01).
[12] SHI JJ.Implementing the "Four Strictest" to Ensure Drug Safety-Interp-retation of the New Version of "The People's Republic of China Drug Administration Law"[J].China Quality and Technical Supervision(中国质量监管),2019(9): 22-23.
[13] ZHANG J, LI HY, GENG XC, et al.On the Latest Guideline to Life-Cycle Management of Pharmaceutical Products and the Roles of Safety Evaluation[J].China Pharmaceutical Affairs(中国药事),2018, 32(6): 770-774.
[14] MITCHELL AA, VAN BENNEKOM CM, LOUIK C.A Pregnancy-Prev-ention Program in Women of Childbearing Age Receiving Isotretinoin[J].The New England Journal of Medicine, 1995, 333(2): 101-106.
[15] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH E2D Guideline: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting[EB/OL].(2003-11-12)[2020-06-23].https://database.ich.org/sites/default/files/E2D_Guideline.pdf.
[16] YE XF.Progress and Thinking of Signal Detection Methodology on Post-Marketing Adverse Drug Reaction Surveillance[J].Academic Journal of Naval Medical University(海军军医大学学报),2022, 43(2): 117-122.
[17] YUAN L, GAO Y, LU CF.Preliminary Thinking on the Establishment of Pharmacovigilance System in China[J].Chinese Journal of Pharma-covigilance(中国药物警戒),2020, 17(11): 749-752.
[18] WANG C, YANG ZM, WANG ZX, et al.Bibliometric Analysis of Active Surveillance of Post-Marketing Drug Safety[J].Chinese Journal of Pharmacoepidemiology(药物流行病学杂志),2024, 33(9): 1054-1063.
[19] National Medical Products Administration Drug Evaluation Center. Regular Benefit Risk Assessment Report(PBRER) E2C(R2)[EB/OL].(2020-07-22)[2024-05-05].http://www.cdr-adr.Org.cn/tzgg_home/202007/t20200722_47625.html.
[20] GOV. Regulations on the Management of Drug Instructions and Labels[S/OL].(2006-03-15)[2024-05-05].https://www.gov.cn/gongbao/content/2007/content_554188.htm.
[21] GOV. Implementation Opinions on Comprehensively Strengthening the Construction of Drug Regulatory Capacity[EB/OL].(2021-05-10)[2024-05-05].https://www.gov.cn/xinwen/2021-05/10/content_5605647.htm.
[22] NMPA. Opinions on Further Strengthening the Monitoring and Eval-uation System and Capacity Building of Adverse Drug Reactions[EB/OL].(2022-04-15)[2020-07-30].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20200731134330152.html.
[23] CDR, NMPA. Guideline for Writing Pharmacovigilance System Master File[EB/OL].(2022-02-25)[2024-05-05].https://www.cdr-adr.org.cn/drug_1/zcfg_1/zcfg_zdyz/202202/t20220228_49518.html.
[24] CDR, NMPA. Annual Report of National Adverse Drug Reaction Monitoring(2023)[EB/OL] .(2024-03-26)[2024-05-05].https://www.
cdr-adr.org.cn.
[25] YUAN L.Building a More Scientific, Efficient, and Authoritative Post-Marketing Drug Regulatory System to Enhance Public Medication Safety[J].China Food and Drug Administration(中国食品药品监管),2024(1): 6-14.
[26] GOV. Measures for Reporting and Monitoring Adverse Drug Reactions[EB/OL].(2011-05-24)[2024-05-05].http://www.gov.cn/flfg/2011-05/24/content_1870110.html.
[27] NMPA. Procedures for Monitoring and Disposing of Cluster Events of Adverse Drug Reactions[EB/OL].(2020-04-13)[2021-04-27].http://www.gov.cn/govweb/zfjg/content_833018.htm.