Chapter 8: Advanced Therapy Medicinal Products (ATMPs)

Over the last few decades a new group of medicinal products have emerged and have been named advanced therapy medicinal products (ATMPs). These are categorised separately from conventional treatments such as pharmaceuticals and medical devices due to their biological origin. The development of ATMPs offers a novel approach in the treatment of disease and injury. Between 2009 and 2017 there were ∼500 ATMPs in clinical trials within the European Union (EU), 13 of which were approved; however, two of these products were later withdrawn and two ended, leaving nine licenced ATMPs on the market by 2019. This chapter introduces this emerging new area and aims to define ATMPs, describe their lifecycle, the regulatory pathway and the current market. As this field is evolving rapidly some of the aspects described here may have changed since the time of writing.