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The ICH, the GHTF, and the Future of Harmonization Initiatives

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Abstract

Comparison of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Global Harmonization Task Force (GHTF), the global regulatory harmonization initiatives in the field of drugs and medical devices, respectively, reveals that “harmonization” activities contain several categories. It was also found that the target level of harmonization (ie, that of technical regulatory requirements and that of regulatory processes) greatly affects the implementability of final work products. Those products concerning regulatory processes (most of the GHTF Documents) often require legal changes and are more difficult to implement than those regarding technical requirements (all of the ICH Guidelines), usually implementable by regulatory authorities publishing them as nonbinding suggestions. Globalization of medical product development, manufacture, and distribution increasingly requires regulatory cooperation across borders, which inevitably affects the initiatives. Identifying what “harmonization” each harmonization initiative aims at is indispensable in determining future directions.

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References

  1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Vision statement. Available at: https://www.ich.org/about/vision.html. Accessed April 26, 2013.

  2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Q&A. Available at: https://www.ich.org/about/faqs.html. Accessed April 26, 2013.

  3. International Medical Device Regulators Forum (IMDRF). GHTF mission summary. Available at: https://www.imdrf.org/ghtf/ghtf-mission.asp. Accessed April 26, 2013.

  4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Steering Committee. Available at: https://www.ich.org/about/organisation-of-ich/steering.html. Accessed April 26, 2013.

  5. International Medical Device Regulators Forum (IMDRF). GHTF archive. Available at: https://www.imdrf.org/ghtf/ghtf-archives.asp. Accessed April 26, 2013.

  6. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Organization of ICH. Available at: https://www.ich.org/about/organisation-of-ich.html. Accessed April 26, 2013.

  7. International Medical Device Regulators Forum (IMDRF). GHTF organizational structure. Available at: https://www.imdrf.org/ghtf/ghtf-structure.asp. Accessed April 26, 2013.

  8. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Formal ICH procedure. Available at: https://www.ich.org/about/process-of-harmonisation/formalproc.html. Accessed April 26, 2013.

  9. International Medical Device Regulators Forum (IMDRF). The GHTF regulatory model. Available at: https://www.imdrf.org/docs/ghtf/final/steering-committee/technical-docs/ghtf-sc-n1r13-2011-ad-hoc-regulatory-model-110413.pdf. Accessed April 26, 2013.

  10. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Global Cooperation Group. Available at: https://www.ich.org/about/organisation-of-ich/coopgroup.html. Accessed April 26, 2013.

  11. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). GCG report. Available at: https://www.ich.org/meetings/gcg-reports.html. Accessed April 26, 2013.

  12. Asian Harmonization Working Party (AHWP). About AHWP. Available at: https://www.ahwp.info/index.php?q=node/7. Accessed April 26, 2013.

  13. International Medical Device Regulators Forum (IMDRF). Statement from GHTF Chair. Available at: https://www.imdrf.org/docs/ghtf/final/media-releases/web-statement-re-future-of-ghtf-28-march-2011-final.pdf. Accessed April 26, 2013.

  14. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Gene Therapy Discussion Group. Available at: https://www.ich.org/products/consideration-documents.html. Accessed April 26, 2013.

  15. International Medical Device Regulators Forum (IMDRF). IMDRF Terms of Reference. Available at: https://www.imdrf.org/pdf/imdrf-tor.pdf. Accessed April 26, 2013.

  16. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Press release of ICH Steering Committee. Fukuoka, Japan. June 6–7, 2012. Available at: https://www.ich.org/ichnews/press-releases/view/article/ich-steering-committee-fukuoka-japan-6-7-june-2012.html. Accessed April 26, 2013.

  17. US Food and Drug Administration. International Cooperation on Cosmetic Regulation (ICCR). Available at: https://www.fda.gov/InternationalPrograms/HarmonizationInitiatives/ucm114513.htm. Accessed April 26, 2013.

  18. Pharmaceuticals and Medical Devices Agency (PMDA). APEC MRCT roadmap: regulatory authorities’ efforts to promote multi-regional clinical trials (MRCTs). Available at: https://www.pmda.go.jp/regulatory/file/english_presentation/international_programs/I-E2tominaga.pdf. Accessed April 26, 2013.

  19. US Food and Drug Administration. Global engagement. Available at: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM298578.pdf. Accessed April 26, 2013.

  20. US Food and Drug Administration. Pathway to global product safety and quality. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/default.htm. Accessed April 26, 2013.

  21. US Food and Drug Administration. EU pilot project on active pharmaceutical ingredient (API) manufacturer inspections. Available at: https://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/EuropeanUnion/EuropeanCommission/ucm114358.htm. Accessed April 26, 2013.

  22. Swissmedic. International Regulators Consortium. Available at: https://www.swissmedic.ch/org/00063/00628/01981/index.html?lang=en. Accessed April 26, 2013.

  23. International Medical Device Regulators Forum (IMDRF). IMDRF meeting. Available at: https://www.imdrf.org/. Accessed April 26, 2013.

  24. Health Canada. Announcement. United States Federal Drug Administration and Health Canada: completion of the Pilot Multipurpose Audit Program (PMAP). Available at: https://www.hc-sc.gc.ca/dhp-mps/md-im/activit/int/md_pmap_ann_im_ppafm-eng.php. Accessed April 26, 2013.

  25. Asia-Pacific Economic Cooperation. APEC Workshop: Advanced Good Review Practice Workshop on Medical Products. Available at: https://www1.cde.org.tw/apec2012/content/APEC%20Workshop%20Circular-V5-(0917).pdf. Accessed April 26, 2013.

  26. European Medicines Agency (EMA). Interactions between the European Medicines Agency and US Food and Drug Administration. September 2009 to September 2010. Available at: https://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/EuropeanUnion/EuropeanCommission/UCM261565.pdf. Accessed April 26, 2013.

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  1. Food and Drug Evaluation Center, Osaka City University Hospital, Asahi-machi 1-2-7 Abeno-ku, Osaka City, Osaka, 545-0051, Japan

    Toshiyoshi Tominaga PhD

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  1. Toshiyoshi Tominaga PhD
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Correspondence to Toshiyoshi Tominaga PhD.

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Tominaga, T. The ICH, the GHTF, and the Future of Harmonization Initiatives. Ther Innov Regul Sci 47, 572–580 (2013). https://doi.org/10.1177/2168479013494393

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