Regulatory considirations for cellular products development: how to accelerate the marketing authorisation in Russia and EAEU


Cite item

Full Text

Abstract

The environment for the development of products containing live cells as an active substance is being set up in Russia for several years. However, the acceptable regulatory framework, which would have allowed to develop and place cell therapy products on the market, complying with international requirements for safety, efficacy, and quality, has not been yet established. Moreover, in addition to the national legal framework, the Eurasian Economic Union regulatory model has emerged that introduces in parallel a more straightforward pathway for the development and clinical use of this important medical product category. In this paper we address the domestic and Eurasian regulatory systems for products containing live cells as an active ingredient and suggest certain possible approaches to support this area of biotechnology.

Full Text

Restricted Access

About the authors

R. R Niyazov

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

R. V Deev

I.I. Mechnikov North-Western State Medical University; Human Stem Cells Institute

Email: pippin.2k@gmail.com
Saint Petersburg, Russia; Moscow, Russia

MA. A Dranitsyna

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

I. E Yasniy

Inbio Ventures

Email: pippin.2k@gmail.com
Moscow, Russia

E. V Gavrishina

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

A. N Vasiliev

Center for Scientific Advice Ltd

Email: pippin.2k@gmail.com
Moscow, Russia

References

  1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Derivation and characterisation of cell substrates used for production of biotechnological/biological products (ICH Q5D). Official website of the ICH. [Online] July 16, 1997. [Cited: October 26, 2019.] https://database.ich.org/sites/default/files/Q5D_Guideline.pdf.
  2. Committee for Medicinal Products for Human Use. Assessment report for MACI (matrix applied characterised autologous cultured chondrocytes). Official web-site of European Medicines Agency. [Online] April 25, 2013. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/assessment-report/maci-epar-public-assessment-report_en.pdf.
  3. Center for Biologics Evaluation and Research. Approval History, Letters, Reviews, and Related Documents - Provenge. Official web-site of U.S. Food and Drug Administration. [Online] May 28, 2019. [Cited: October 18, 2019.] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/provenge-sipuleucel-t.
  4. Approval History, Letters, Reviews, and Related Documents - Laviv. Official web-site of U.S. Food and Drug Administration. [Online] March 16, 2018. [Cited: October 18, 2019.] https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/laviv-azficel-t.
  5. Committee for Medicinal Products for Human Use. Assessment report for Kymriah (tisagenlecleucel). Official web-site of European Medicines Agency. [Online] June 28, 2018. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/assessment-report/kymriah-epar-public-assessment-report_en.pdf.
  6. Assessment report for Yescarta (axicabtagene ciloleucel). Official web-site of European Medicines Agency. [Online] June 22, 2018. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/assessment-report/yescarta-epar-public-assessment-report_en.pdf.
  7. Therapeutic Goods Administration. Australian Public Assessment Report for Remestemcel-L, ex vivo adult human mesenchymal stem cells. Official website of the Therapeutic Goods Administration. [Online] March 5, 2015. [Cited: Noveber 10, 2019.] https://www.tga.gov.au/sites/default/files/auspar-remestemcel-l-150315.pdf.
  8. Committee for Medicinal Products for Human Use. Assessment report for darvadstrocel (expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue). Official web-site of European Medicines Agency. [Online] December 14, 2017. [Cited: November 10, 2019.] https://www.ema.europa.eu/en/documents/assessment-report/alofisel-epar-public-assessment-report_en.pdf.
  9. Guideline on human cell-based medicinal products. Official web-site of European Medicines Agency. [Online] May 21, 2008. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-human-cell-based-medicinal-products_en.pdf.
  10. Committee for Advanced Therapies (CAT). Reflection paper on stem cell-based medicinal products. Official web-site of European Medicines Agency. [Online] January 11, 2011. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-stem-cell-based-medicinal-products_en.pdf.
  11. Reflection paper on clinical aspects related to tissue engineered products. Official web-site of European Medicines Agency. [Online] September 19, 2014. [Cited: October 18, 2019.] https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-clinical-aspects-related-tissue-engineered-products_en.pdf.
  12. Center for Biologics Evaluation and Research. Cellular Therapy for Cardiac Disease: Guidance for Industry. Official web-site of U.S. Food and Drug Administration. [Online] October 2010. [Cited: October 18, 2019.] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ cellular-therapy-cardiac-disease.
  13. U.S. Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry. Official web-site of U.S. Food and Drug Administration. [Online] December 19, 2018. [Cited: October 18, 2019.] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-endpoints-approval-cancer-drugs-and-biologics.
  14. Center for Biologics Evaluation and Research. Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry. Official web-site of U.S. Food and Drug Administration. [Online] Nobember 1, 2013. [Cited: October 18, 2019.] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products.
  15. Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors. Official web-site of U.S. Food and Drug Administration. [Online] April 1,2008. [Cited: October 18, 2019.] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-review-chemistry-manufacturing-and-control-cmc-information-human-somatic-cell-therapy.
  16. Министерство здравоохранения Российской Федерации. Об утверждении Правил надлежащей клинической практики биомедицинских клеточных продуктов (с изменениями на 30 января 2019 года). Электронный фонд правовой и нормативно-технической документации «Консорциум «Кодекс». [Online] января 30, 2019. [Cited: октября 18, 2019.] http://docs.cntd.ru/document/542608950.
  17. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Guideline for good clinical practice (ICH E6(R2)). Official website of the ICH. [Online] November 9, 2016. [Cited: October 26, 2019.] https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
  18. Министерство здравоохранения Российской Федерации. Об утверждении Правил надлежащей практики по работе с биомедицинскими клеточными продуктами. Электронный фонд правовой и нормативно-технической документации «Консорциум «Кодекс». [Online]
  19. European Commission. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. EudraLex, The Rules Governing Medicinal Products in the European Union, Volume 4. [Online] November 22, 2017. [Cited: October 18, 2019.] https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guide-lines_gmp_for_atmps.pdf.
  20. European Parliament, Council of the European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. EUR-Lex: Access to European Union law. [Online] July 18, 2009. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1565510 251540&uri=CELEX:02004L0023-20090807.
  21. European Commission. Commission Directive 2006/17/ EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. EUR-Lex. [Online] December 17, 2012. [Cited: October 18, 2019.] https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1571409314568&uri=C ELEX:32006L0017.
  22. /453/EU: Commission Decision of 3 August 2010 establishing guidelines concerning the conditions of inspections and control measures, and on the training and qualification of officials, in the field of human tissues and cells. EUR-Lex. [Online] August 3, 2010. [Cited: October 18, 2019.] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32010D0453.
  23. Inspection of tissue and cell procurement and tissue establishments: Operational Manual for Competent Authorities. Official web-site of the European Commission. [Online] April 29, 2015. [Cited: October 18, 2019.] https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/manual_11_en.pdf.
  24. Соглашение о единых принципах и правилах обращения лекарственных средств в рамках Евразийского экономического союза. Электронный фонд правовой и нормативно-технической документации «Консорциум «Кодекс». [Online] декабря 23, 2014. [Cited: октября 26, 2019.] http://docs.cntd.ru/document/420307203/.
  25. Совет Евразийского экономического союза. О Правилах регистрации и экспертизы лекарственных средств для медицинского применения (с изменениями на 14 июня 2018 года). Электронный фонд правовой и нормативно-технической документации «Консорциум «Кодекс». [Online] июня 14, 2018. [Cited: октября 26, 2019.] http://docs.cntd.ru/document/456026097.
  26. Совет Евразийской экономической комиссии. Правила проведения исследований биологических лекарственных средств Евразийского экономического союза. Электронный фонд правовой и нормативно-технической документации «Консорциум «Кодекс». [Online] ноября 3, 2016. [Cited: октября 27, 2019.] http://docs.cntd.ru/document/456026116.

Copyright (c) 2020 PJSC Human Stem Cells Institute


СМИ зарегистрировано Федеральной службой по надзору в сфере связи, информационных технологий и массовых коммуникаций (Роскомнадзор).
Регистрационный номер и дата принятия решения о регистрации СМИ: ПИ № ФС 77 - 57156 от 11.03.2014.

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies