国外药品上市许可持有人委托开展药物警戒监管对我国的启示

doi:10.19803/j.1672-8629.2020.11.05

摘要/Abstract

摘要： 目的基于《中华人民共和国药品管理法》和《药品生产监督管理办法》关于药品上市许可持有人开展药物警戒的制度要求,探讨我国药品上市许可持有人委托开展药物警戒模式及其管理方式。方法研究美国、欧洲、英国等药品监管机构关于药品上市许可持有人委托开展药物警戒的规章制度,对比我国的法律法规,结合我国《药物警戒委托协议撰写指导原则》,对药物警戒委托活动的开展提出建议。结果与结论 明确药品上市许可持有人和受托方的责任与义务是进行药物警戒委托的基础,药品上市许可持有人应对受托方药物警戒工作进行考核评估,药品监管机构的药物警戒检查工作应涵盖受托方的检查,应侧重检查法规执行和药物安全性数据的管理。

关键词: 药物警戒, 委托, 管理, 药品上市许可持有人

Abstract: Objective To explore modes and management methods of pharmacovigilance subcontracted by marketing authorization holders in China based on system requirements for marketing authorization holders stipulated by the Drug Administration Law and the Measures for the Supervision over and Administration of Pharmaceutical Production. Methods The laws and regulations enacted by drug regulatory authorities concerning pharmacovigilance subcontracted by marketing authorization holders in the United States, Europe, and the United Kingdom were studied and compared with those of China. Combined with the guidelines for pharmacovigilance entrustment agreements in China, opinions or suggestions on the development of pharmacovigilance commission activities were presented. Results & Conclusion To clarify the responsibilities and obligations of the holder and the trustee is the basis of pharmacovigilance commission. Holders should evaluate pharmacovigilance practices of trustees. Pharmacovigilance inspection by drug regulatory agencies should cover the inspection of trustees and focus on the inspection of compliance and management of drug safety data.

Key words: pharmacovigilance, commission, administration, marketing authorization holder

中图分类号:

R951

刘丽丽. 国外药品上市许可持有人委托开展药物警戒监管对我国的启示[J]. 中国药物警戒, 2020, 17(11): 773-776.

LIU Lili. Pharmacovigilance Subcontracted by Foreign Marketing Authorization Holders[J]. Chinese Journal of Pharmacovigilance, 2020, 17(11): 773-776.

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https://zgywjj.magtechjournal.com/CN/Y2020/V17/I11/773

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