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The EMA has approved more than 25 advanced therapy medicinal products since the ATMP regulation came into force in 2007, putting it among the world's most active regulators for cell and gene therapy.
Behind every approval sits a medical-safety sign-off that determines whether a one-shot cell or gene therapy reaches European patients.
Steffen Thirstrup is the EMA's Chief Medical Officer, the senior physician advising the agency on benefit-risk decisions for all medicines, including the ATMPs that have made Europe one of the world's most active jurisdictions for cell and gene therapy. With a PhD in pharmacology and a career spanning Denmark's medicines regulator, EMA's CHMP and the Committee for Advanced Therapies, Thirstrup has been at the centre of how Europe assesses the first generation of living medicines and is now shaping how the agency adapts to the next wave of personalised, in-vivo and platform-based therapies.
At Meeting on the Med 2026, reporting for Onyx, Federico Citterich sat down with Steffen Thirstrup to find out more.
A special thanks to our Onyx Live sponsors:
Cellares - delivering cell therapy manufacturing excellence at scale across a global network of IDMO smart factories https://www.cellares.com/
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