欧盟SPOR项目概述及启示

doi:10.19803/j.1672-8629.2019.12.03

中国药物警戒 ›› 2019, Vol. 16 ›› Issue (12): 716-721.
DOI: 10.19803/j.1672-8629.2019.12.03

欧盟SPOR项目概述及启示

侯永芳¹, 刘红亮¹, 李馨龄¹, 刘玲²

¹国家药品监督管理局药品评价中心,北京 100022;
²东部战区总院龙蟠中路门诊部药械科,江苏南京 210016

收稿日期:2019-12-18 修回日期:2019-12-18 出版日期:2019-12-15 发布日期:2019-12-18
作者简介:侯永芳,男,硕士,副主任药师,药品不良反应监测与评价。

An Overview of EU SPOR Project

HOU Yongfang¹, LIU Hongliang¹, LI Xinling¹, LIU Ling²

¹Center for Drug Reevaluation, NMPA, Beijing 100022, China;
²Department of Pharmacy of Longpan Middle Road Clinic, Eastern Theater General Hospital, Nanjing Jiangsu 210016, China

Received:2019-12-18 Revised:2019-12-18 Online:2019-12-15 Published:2019-12-18

摘要/Abstract

摘要： 目的分析欧盟SPOR项目的具体执行流程,为我国建立符合IDMP标准药品字典提供思路和参考。方法研究IDMP标准的构成及欧盟SPOR项目的实践,分析欧盟建立符合IDMP标准的药品字典的实现方式,并结合中国国情进行对照。结果 IDMP标准涉及的数据结构庞大,通过SPOR项目可以合理地将庞大的目标拆分成具体阶段执行,并在执行过程中充分与各参与方进行交流和协作。结论 SPOR项目可以提升医药产品数据质量,改善监管行为和决策的效率,减少数据孤岛,提高数据复用率以降低成本等,值得我国进行借鉴。

关键词: SPOR, 药品字典, IDMP

Abstract: Objective To study the details of implementation of EMA SPOR Program so as to offer ideas and referential methodologies for IDMP-related practices in China. Methods IDMP standards as well as the EMA SPOR Program were studied by analyzing the ways in which a drug dictionary was compiled by the EU that complies with the IDMP standards. A comparison was also made with the actual situation in China. Results IDMP standards involve an enormous data structure, and the SPOR Program effectively divides the whole process into reasonable and executable phases, allowing smooth communication and collaboration between stakeholders across phases. Conclusion The implementation of the SPOR Program will be of multiple benefits: increased data quality, more efficient regulatory action and decision-making, reduced data silos and operational savings and efficiencies due to re-usage of data.

Key words: SPOR, drug dictionary, IDMP

中图分类号:

R951

侯永芳, 刘红亮, 李馨龄, 刘玲. 欧盟SPOR项目概述及启示[J]. 中国药物警戒, 2019, 16(12): 716-721.

HOU Yongfang, LIU Hongliang, LI Xinling, LIU Ling. An Overview of EU SPOR Project[J]. Chinese Journal of Pharmacovigilance, 2019, 16(12): 716-721.

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欧盟SPOR项目概述及启示

An Overview of EU SPOR Project

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