Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024
This study emphasises the instrumental role of RWD in the post-authorisation monitoring of ATMPs in the European Union. PAMs reflect the regulatory flexibility for these products, shifting some efforts to the post-authorisation phase to address benefit-risk gaps. Enhancing the use of RWD in this context could improve evidence generation, minimise uncertainties and support more informed regulatory decisions.
Authors
- Peter G. M. Mol (ORCID: https://orcid.org/0000-0002-4262-3180)
- Carla Torre (ORCID: https://orcid.org/0000-0002-5542-9993)
- Bruno Sepodes (ORCID: https://orcid.org/0000-0002-2761-0955)
- Diogo Fraxino de Almeida (ORCID: https://orcid.org/0009-0004-5648-2800)
- Diana Mandslay
Institutions
- University Medical Center Groningen (NL)
- University of Lisbon (PT)
- University of Groningen (NL)
Publication Details
- Journal
- BioDrugs
- Published
- 2025-08-26
- DOI
- https://doi.org/10.1007/s40259-025-00737-x
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Universidade de Lisboa