Abstract
Whereas some basic therapies based on tissues and cells have been in clinical use for years, regulatory regimes applying to such applications have recently been revised and extended in Europe and in the US. Moreover, advances in regenerative medicine present new challenges and new types of products for regulation.
Both European and US regulators have developed rules to distinguish ‘complex’ cell therapies from their more established predecessors. In Europe, regulation of medicines and tissues and cells has now been supplemented by the regulation of ‘Advanced Therapies’ that is specifically relevant for regenerative medicine. We discuss the European legislative framework with reference to Germany and the UK as examples how the common rules are implemented. We also show how similar distinctions are made in the United States and consider the stance of the FDA on clinical development of novel cell therapies.
In conclusion, we briefly discuss whether the proposed regulatory regimes strike the appropriate balance between protecting patient safety and promoting innovation in regenerative medicine.
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Notes
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A list of notified bodies can be found at http://ec.europa.eu/enterprise/newapproach/nando/
- 2.
Press release: MEMO/08/774, 08/12/2008.
- 3.
Following a recent rebranding, the European Medicines Agency is no longer using the acronym EMEA, but is also not using EMA. Here we have opted for EMEA to avoid confusion for those used to the old abbreviation.
- 4.
MHRA Concept paper on the project to consolidate and review medicines legislation; Jan 2009.
- 5.
- 6.
Beginning with the “Reinventing the Regulation of Human Tissue” discussion paper CBER February 1997.
- 7.
Definition of primary mode of action of a combination product. Fed Regist 70(164, Aug 25):49848–49862.
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- 9.
CTGTAC Meeting #45, April 10, 2008 Briefing: “Cellular Therapies Derived from Human Embryonic Stem Cells – Considerations for Pre-Clinical Safety Testing and Patient Monitoring”.
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- 11.
FDA Draft Guidance for Industry: INDs—Approaches to Complying with CGMP During Phase 1.
- 12.
Pharmaceutical Inspection Co-operation Scheme. Recommendation on sterility testing, Pharmaceutical inspection convention (1 November 2002) PI 012-1.
- 13.
Cobe et al. (2007) Microbiological contamination in stem cell cultures. Cell Biol Int 31(September)991–995.
- 14.
FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs; July 2008.
Acknowledgements
We are grateful to Dr. Anke Wagner (RTC Rostock), for her expert advice, craftsmanship and patience in designing the illustrations in this chapter.
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© 2013 Springer Science+Business Media Dordrecht
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Tiedemann, G., Sethe, S.C. (2013). Regulatory Frameworks for Cell and Tissue Based Therapies in Europe and the USA. In: Steinhoff, G. (eds) Regenerative Medicine. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-5690-8_44
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DOI: https://doi.org/10.1007/978-94-007-5690-8_44
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