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中国医药导刊 ›› 2021, Vol. 23 ›› Issue (10): 795-800.

所属专题: 《药物警戒质量管理规范》(GVP)

• GVP专栏 • 上一篇    

药物警戒制度中个例安全性报告(ICSR)递交质量保证要点分析

王广平1,魏晓菲2,徐菊萍2*   

  1. 1.上海市药品和医疗器械不良反应监测中心,上海 200040; 2.浙江太美医疗科技股份有限公司,上海 200233
  • 收稿日期:2021-08-23 修回日期:2021-10-11 出版日期:2021-10-28 发布日期:2021-10-28
  • 基金资助:
    中国药品监督管理研究会2021年度研究课题[项目名称:药品良好监管体系规范(GRP)的建设原则和框架研究]

Analysis on the Key Points of Quality Assurance in Submission ofIndividual Case Safety Reports(ICSR) in Pharmacovigilance Systems

  1. 1.Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200040,China;  2.Zhejiang Taimei Medical Technology Co., Ltd.,Shanghai 200233,China
  • Received:2021-08-23 Revised:2021-10-11 Online:2021-10-28 Published:2021-10-28

摘要: 药物警戒是药品全生命周期质量管理的重要内容,是确保公众用药安全的重要手段。我国首版《药物警戒质量管理规范》(GVP)的发布推动了我国药物警戒能力的建设。建立健全我国药物警戒制度和体系是当前药品监管机构和药品上市许可持有人(MAH)亟待解决的重大问题和挑战。个例安全性报告(ICSR)递交质量保证体系建设,是推进企业药物警戒制度建设和政府与企业风险沟通的有效途径。本研究基于国内外医药企业在ICSR递交中面临着的术语差异、系统对接复杂性以及递交合规性要求等方面的挑战,根据全面质量管理(TQM)“人、机、料、法、环”思路,对ICSR递交质量保证中的人员要求、信息系统、数据质量、法规标准、质量意识和诚信文化等要点进行分析,以满足政府和企业风险沟通过程中的药物警戒要求。
  

关键词: font-size:medium, ">药物警戒质量管理规范;药物警戒;个例安全性报告;质量保证

Abstract: Pharmacovigilance is an important part of the whole life cycle quality management of medicines, and is an important means to ensure medication safety for the public. The release of the first edition of Good Pharmocovigilance Practice(GVP) in China also promoted the construction of pharmacovigilance capacity. Establishing and improving pharmacovigilance system is a major issue and challenge that needs to be resolved urgently by the national regulatory agencies and drug marketing authorization holdes(MAH).The submission quality assurance system of individual case safety reports(ICSR) is an effective way to promote the construction of pharmacovigilance system and risk communication between enterprises and the government. Based on the challenges of terminology differences, complexity of system interface and compliance requirements in ICSR submission for domestic and foreign pharmaceutical companies, this paper analyzes the key points of ICSR submission quality assurance, such as personnel requirements, information systems, data quality, regulatory standards, quality awareness and integrity culture in terms of total quality management (TQM)“submission personnel, tools, related materials, regulatory indicators, awareness and culture”, aiming to meet the requirements on pharmacovigilance of government and corporate risk communication process.

Key words: Good Pharmocovigilance Practice;Pharmacovigilance, Individual case safety reports, Quality assurance

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