Cell Therapy in Practice

Figueiredo, GS; De, Havilland, JR; Lako, M; Figueiredo, FC

doi:10.1002/9781118743362.ch8

Cell Therapy in Practice

Lookup NU author(s): Dr Gustavo Figueiredo, Dr Julian De Havilland, Professor Majlinda Lako ORCiD, Professor Francisco Figueiredo ORCiD

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Abstract

© 2017 by John Wiley & Sons, Ltd. All rights reserved. Human cells, tissues, or cellular or tissue-based products (HCT/Ps) means articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient. In addition, the interpretation of what amounts to "substantial manipulation" has significant impact on the classification of cell therapies as Advanced Therapy Medicinal Products (ATMPs). ATMPs have been brought about by progress in scientific developments across a range of academic disciplines. As new experimental products developed based on genes, cells and tissues, challenges as to how these new products could be controlled and regulated to ensure public safety and efficacy, emerged. To cope with these developments within the European Union, Regulation (EC) No. 1394/2007 of the European Parliament and of the Council, on ATMP was adopted in 2007. These regulations were introduced for two purposes; firstly to protect human health and secondly to enable the free movement of ATMPs within the European Union.