INTERNATIONAL APPROACHES TO THE REGULATION OF CELL THERAPY PRODUCTS

Cover Page

Abstract


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.   


N. V. Pyatigorskaya

I.M. Sechenov First Moscow State Medical University, Russian Federation

Author for correspondence.
Email: osipova-mma@list.ru

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

M. A. Tulina

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: mari_bel_90@mail.ru

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

Zh. I. Aladysheva

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: osipova-mma@list.ru

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

V. V. Beregovykh

I.M. Sechenov First Moscow State Medical University, Russian Federation

Email: osipova-mma@list.ru

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

  1. 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.

Views

Abstract - 19

PDF (Russian) - 15

Cited-By


PlumX

Dimensions



Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

This website uses cookies

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

About Cookies