Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing or regenerating cells, tissues or organs in Human. In Europe, they are governed by the ATMP regulation, which entered into force in 2007.
This short presentation introduces the regulatory landscape for regenerative medicines in Europe, and discuss the main features that have been implemented. Three incentives implemented by the European Medicines Agency (EMA) for developers of regenerative medicines are also detailed.
Emmanuelle Sabbah-Petrover is Associate Director, Complex Biologics at VCLS. Emmanuelle manages projects involving Advanced Therapy Medicinal Products (ATMP) especially gene therapy; from Non-Clinical to Clinical development phases, both in Europe & US.View Profile