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, Director Complex Biologics
Emmanuelle manages projects involving cell, gene & tissue-based medicinal products (“ATMPs”); from non-clinical to clinical phases, both in Europe & the US. Emmanuelle has a particular expertise in GMO requirements for experimental drugs in Europe. Emmanuelle brings 12 years of experience in the biotech industry. Her Ph.D. in science added to R&D experience allows her understanding the constraints & challenges that developers faced daily.