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British Journal of Clinical Pharmacology
Article . 2026 . Peer-reviewed
License: CC BY NC
Data sources: Crossref
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Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status

Authors: Allan Cramer; Freja Karuna Hemmingsen Sørup; Marie Lund; Tonny Studsgaard Petersen; Kristian Karstoft;

Advanced therapy medicinal products (ATMPs) – An analysis of the global regulatory status

Abstract

Abstract Background A rapid progress in the development of advanced therapy medicinal products (ATMPs) has taken place over the past decades. The ATMPs hold great potential but face challenges in the clinical development and the regulatory process. Objective To investigate the current global regulatory status of ATMPs by systematically identify, characterize and compare ATMPs granted marketing authorization (MA) by regulatory agencies across the globe. Methods We performed an analysis of ATMPs with MA on January 1, 2025, granted by the regulatory agencies in USA, EU, Japan, UK, Canada, Australia and Switzerland. Results A total of 59 different ATMPs had been granted an MA by at least one of the included agencies. Gene therapy medicinal product was the most common type of ATMP (42%), and haematology was the most common therapeutic area (44%). The number of ATMPs that had been granted MA ranged from 43 in the USA to 7 in Australia. Five (8%) of the ATMPs had been granted MA across all the included agencies, while 17 (29%) of the ATMPs had been granted MA by more than one agency. Conclusions This study showed substantial variation between agencies in the number of ATMPs that had been granted MA. Around one‐third of the ATMPs had been granted MA by more than one agency. Assuming that the ATMPs are offering a clinical benefit for the patients, limited global dissemination is a problem as it hinders the accessibility to patients globally resulting in health care inequality.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
hybrid