Annals of the Russian academy of medical sciencesAnnals of the Russian academy of medical sciencesВестник Российской академии медицинских наук0869-60472414-3545"Paediatrician" Publishers LLC15110.15690/vramn.v68i8.715EDITORIALОТ РЕДАКЦИИINTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTSМЕЖДУНАРОДНЫЕ ПОДХОДЫ К РЕГУЛИРОВАНИЮ ПРЕПАРАТОВ КЛЕТОЧНОЙ ТЕРАПИИPyatigorskayaN. V.ПятигорскаяН. В.
Russian Federation

PhD, Deputy director for Research of Research Institute of Pharmacy, professor of the Department of Industrial Pharmacy, I.M. Sechenov First Moscow State Medical University Address: 45, Nakhimovsky avenue, Moscow, 117418; tel.: (499) 128-57-55

osipova-mma@list.ruTulinaM. A.ТулинаМ. А.
Russian Federation

postgraduate student of the Laboratory of Analysis and Technology of the Department of Drug Discovery of Research Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-55

mari_bel_90@mail.ruAladyshevaZh. I.АладышеваЖ. И.
Russian Federation

MD, associate professor of the Department of Industrial Pharmacy of I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-55

osipova-mma@list.ruBeregovykhV. V.БереговыхВ. В.
Russian Federation

PhD, professor, cor. member of RAMS, assistant to the President of RAMS, Head of the Department of Industrial Pharmacy of I.M. Sechenov First Moscow State Medical University Address: 117418, Moscow, Nakhimovsky avenue, 45; tel.: (499) 128-57-77

osipova-mma@list.ruI.M. Sechenov First Moscow State Medical University, Russian FederationПервый Московский государственный медицинский университет им. И.М. Сеченова, Российская Федерация19082013688Vestnik Rossiiskoi akademii medetsinskikh nauk / Annals of the Russian academy of medical sciencesВестник Российской академии медицинских наук4807082015Copyright ©; 1970, "Paediatrician" Publishers LLCCopyright ©; 1970, Издательство "Педиатръ"1970"Paediatrician" Publishers LLCИздательство "Педиатръ"https://vestnikramn.spr-journal.ru/jour/about/submissionshttps://vestnikramn.spr-journal.ru/jour/article/view/151

This article is a review of the main methods and approaches used in regulation of cell therapy products in the United States of America, Canada, European Union, Australia, Japan and South Korea. Intensive developments of scientific and technological aspects in stem cell and tissue engineering have led to the wide use of human cells and tissues for the treatment of various diseases and injuries of organs and tissues. Drug regulatory agencies of different countries are working on implementation of a risk-based legal framework with some common features. In many countries there is a multilevel control system that assures quality and safety of used cell products. Competent authorities establish strict requirements both to safety of the products and to the implemented standards of good laboratory, manufacturing, clinical and tissue practices.

В обзоре описаны основные международные подходы и направления нормативного регулирования препаратов клеточной терапии в США, Канаде, Европе, Австралии, Японии и Южной Корее. Интенсивное научно-технологическое развитие клеточной и тканевой инженерии привело к активному использованию человеческих клеток и тканей для лечения различных заболеваний и комбинированных повреждений. Регуляторные органы разных стран работают над установлением нормативно-правовой базы, основанной на оценке рисков, с некоторымиобщими чертами. В ряде стран мира имеется многоступенчатая система контроля, гарантирующая качество и безопасность применения клеточного продукта. Государственные регуляторные органы предъявляют жесткие требования не только к безопасности самой продукции, но и к стандартам осуществления надлежащей лабораторной, производственной, клинической и тканевой практики.

cell therapystem cellsregulatory frameworksinternational approachклеточная терапиястволовые клеткирегуляторная базамеждународный подход1. Weber D.J. Navigating FDA Regulations for Human Cells and Tissues. BioProcessing Int. 2004; 2 (8): 22–26.2. Weber D.J. Understanding and Implementing GTPs. Regulatory Focus. 2008 N.9 p.19–28.3. Kellathur S.N., Lou H.-H. Cell and tissue therapy regulation: worldwide status and harmonization. Biologicals. 2012; 40 (3): 222–224.4. Howe R.J., Howe M.A., Tankovich N., Howe D.A. The miracle of stem cells. USA: Stemmedia. 2011. 248 p.5. Shapiro J.K., Wesoloski B.J. FDA’s Regulatory Scheme for Human Tissue/ Human Tissue Regulation. 2007, N 11/12-P. 9–12.6. US Food and Drug Administration Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Silver Spring 2007.7. US Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Silver Spring, 2004.8. US Food and Drug Administration. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), Silver Spring, 2011.9. Guide to the safety and Quality Assurance for the Transplantation of Organs, Tissue and cells. European Directorate for the Quality of Medicine & HealthCare. Council of Europe, Strasburg.10. European commission’s draft detailed guidelines on good clinical practice specific to advanced therapy medicinal products, Brussel, 2009.11. Therapeutic goods administration, Australia’s regulatory framework for biological, Symonston 2011.12. Safety of human cells, tissues and organs for transplantation regulations. Canada. 2009.13. Food and Drug regulations. Canada. 2013.14. Guidelines for Private Hospitals, Medical Clinics and Clinical Laboratories. Ministry of Health Singapore. 2007.15. Pharmaceutical Affairs Act. South Korean Food and Drug Administration. 2010.16. Japan Pharmaceutical Affairs Law. Tokyo, 2013.