Regulatory Frameworks for Cell and Tissue Based Therapies in Europe and the USA

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.