Meeting on the Med 2021 | Driving the ATMP sector forward: a regulatory perspective

Ana Hidalgo-Simon, MD, PhD, European Medicines Agency (EMA), Amsterdam, Netherlands, discusses ongoing trends in the field of advanced therapy medicinal products (ATMPs) and the perception that the rate of ATMP approvals has not met expectations in recent years. Compliance with chemistry, manufacturing, and controls (CMC) standards set out by regulatory agencies remains a key challenge currently facing the sector and it is advised that ATMP manufacturers focus on CMC from the early stages of development. Dr Hidalgo-Simon also describes the role regulatory agencies can play in assisting the development of ATMPs, including the Priority Medicines (PRIME) scheme launched by the EMA. This interview took place during the Cell & Gene Meeting on the Mediterranean 2021 virtual conference.