An Overview of EU SPOR Project

doi:10.19803/j.1672-8629.2019.12.03

Abstract

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

CLC Number:

R951

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

References

[1] NMPA.总局关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号)[EB/OL].(2018-01-25)[2019-01-07].http://www.nmpa.gov.cn/WS04/CL2182/300493.html.
[2] 叶小飞,郭晓晶,赵璐,等.个例安全性报告规范(ICH E2B)简介及应用[J].中国药物警戒, 2012, 9(3):149-151.
[3] 侯永芳,董铎,熊玮仪,等.个例安全性报告E2B规范的发展[J].中国药物警戒, 2018, 15(3):144-146.
[4] ICH.Implementation Guide for Electronic Transmission of Individual Case Safety Reports(ICSRs),Version5.02[EB/OL].(2016-11-10)[2019-01-07].https://www.pmda.go.jp/files/000219341.pdf.
[5] Giuliana Miglierini.ISO Excellence Award to five EMA’s experts for their achievements in the development of ISO IDMP standards[EB/OL].(2018-11-21)[2019-01-07].https://www.pharmaworldmagazine.com/iso-excellence-award-to-five-emas-experts-for-their-achievements-in-the-development-of-iso-idmp-standards/
[6] International Organization for Standardization.ISO 11238:2012 Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated information on substances[EB/OL].(2012-11)[2019-01-07]. https://www.iso.org/standard/55031.html.
[7] International Organization for Standardization.ISO 11239:2012 Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging[EB/OL].(2012-11)[2019-01-07]. https://www.iso.org/standard/55032.html.
[8] International Organization for Standardization. ISO 11240:2012 Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of units of measurement[EB/OL].(2012-11)[2019-01-07]. https://www.iso.org/standard/55033.html.
[9] International Organization for Standardization. ISO 11616:2012 Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information [EB/OL].(2012-11)[2019-01-07]. https://www.iso.org/standard/55035.html.
[10] International Organization for Standardization. ISO 11615:2012 Health informatics-Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information [EB/OL].(2012-11)[2019-01-07]. https://www.iso.org/standard/55034.html.
[11] EMA. Task Force for the implementation of International Standards on Identification of Medicinal Products in the EU(i.e. EU IDMP/SPOR Task Force)[EB/OL].(2016-09-01)[2019-01-07]. https://www.ema.europa.eu/en/documents/other/task-force-implementation-international-standards-identification-medicinal-products-eu-ie-eu-iso_en.pdf.
[12] EMA.Data on medicines (ISO IDMP standards): Overview[EB/OL].(2016-12-01)[2019-01-07]. https://www.ema.europa.eu/en/human-regulatory/overview/data-medicines-iso-idmp-standards-overview.
[13] EMA.Introduction to ISO Identification of Medicinal Products,SPOR programme [EB/OL].(2016-11-29)[2019-01-07].https://www.ema.europa.eu/en/documents/other/introduction-iso-identification-medicinal-products-spor-programme_en.pdf.
[14] EMA.Data submission of authorised medicines in the European Union [EB/OL].(2015-02-23)[2019-01-07]. https://www.ema.europa.eu/en/documents/other/data-submission-authorised-medicines-european-union-outlines-article-572-regulation-ec-no-726/2004_en.pdf.
[15] EMA.European Medicines Agency (EMA) Master Data Management Roadmap [EB/OL].(2015-04-23)[2019-01-07].https://www.ema.europa.eu/en/documents/other/european-medicines-agency-master-data-management-roadmap_en.pdf.
[16] The European CRO Federation(EUCROF). Pharmacovigilance in2020:Boldly Shaping the Future:An overview; Part 2:Identification of Medicinal Products (IDMP) implementation [EB/OL].(2018-06-14)[2019-01-07]. https://www.eucrof.eu/images/Documents/18-08-17-idmp-implementation_eucrof_pv_wg-8aug2018_final_nt.pdf.
[17] 国家医疗保障局. 国家医保局人力资源社会保障部关于印发《国家基本医疗保险、工伤保险和生育保险药品目录》的通知[EB/OL].(2019-08-20) [2019-09-01]. http://www.nhsa.gov.cn/art/2019/8/20/art_37_1666.html.
[18] 全国人民代表大会.《中华人民共和国药品管理法》[EB/OL]. (2019-08-26)[2019-09-01].http://www.npc.gov.cn/npc/c30834/201908/26a6b28dd83546d79d17f90c62e59461.shtml.
[19] 国家药监局. 国家药监局关于发布《药品追溯系统基本技术要求》等3项信息化标准的公告[EB/OL]. (2019-08-27)[2019-09-01]. http://www.nmpa.gov.cn/WS04/CL2138/357732.html.
[20] Julie M. James.Global implications of the implementation of IDMP[EB/OL]. (2017-01-11)[2019-01-07].https://www.genpact.com/insight/blog/global-implications-of-the-implementation-of-idmp.
[21] Monica McDonnell. The Challenge of IDMP Compliance [EB/OL].(2017-02-28)[2019-01-07]. http://www.pharmtech.com/challenge-idmp-compliance.