The globalisation of regenerative medicine is gathering pace yet has not been examined with respect to its medium and long-term implications for European regulators, the corporate and clinical sectors or patients located within different member states. Over the coming years it is hypothesised that the global pace of change in this field will be extensive, though uneven, and this needs to be both tracked and assessed to provide basic empirical and analytical research results to be made available to healthcare systems across Europe. It is a field that is characterized by complex dynamics across a range of scientific, clinical and industrial sectors, highly unstable, yet developing rapidly. Regenerative Medicine (RM) is also important to Europe given the emerging competition from Asia/Pacific and North America regions that are making health biotech development a priority and investing in what they perceive to be an industry of the future. April 24 th 2007 saw the EU Parliament adopt the ‘Advanced Therapies Regulation’ to harmonise guidelines that will, if approved by the Council, create a centralised process for approving new tissue and cell engineering therapies. This is an important basis for stabilising the RM market and research in Europe : this project examines the current and emerging socio-economic, political and bioethical issues that will need to be addressed in Europe as work in the RM field accelerates.