ArticleBritish journal of clinical pharmacology2026
Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
2 citing papers in PubMed.
- MSC-Hydrogel Composite Systems for Knee Cartilage Repair and Osteoarthritis: A Systematic Review.Gels (Basel, Switzerland) · 2026Review
- Advanced therapy medicinal products (ATMPs) - An analysis of the global regulatory status.British journal of clinical pharmacology · 2026Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA 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.
objectiveTo 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.
methodsWe 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.
resultsA 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.
conclusionsThis 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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Registered trials
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