Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

With the proposal for major reform of the pharmaceutical legislation (Regulation (EU) 2023/0131, Directive (EU) 2023/0132) in April 2023, the foundations of Europe's regulatory architecture are being reshaped. The revised legislation proposes the removal of specialized committee functions (e.g., Committee for Advanced Therapies-CAT) by integrating their remit into other regulatory bodies, such as the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) and expert working groups. This decision may further challenge innovation in Europe, particularly in the field of advanced therapy medicinal products (ATMPs), which has already experienced a notable decline in global clinical trial activity over the past decade. This article emphasizes the importance of involving multistakeholder consortia such as T2EVOLVE in shaping pharmaceutical legislation to prevent the loss of specialized knowledge and the need for robust mechanisms that preserve developers' access to ATMP regulatory expertise.

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Publication Details

Journal
Cytotherapy
Published
2025-09-24
DOI
https://doi.org/10.1016/j.jcyt.2025.09.007
Primary Topic
Biomedical Ethics and Regulation
Type
article
Field-Weighted Citation Impact
0.00

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article

Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

Maria Quaranta, Bernd Schröder, Anne Galy, Nina Worel et al.
Cytotherapy
Biomedical Ethics and Regulation
article

Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe

Maria Quaranta, Bernd Schröder, Anne Galy, Nina Worel, Ulrike Philippar, Felipe Prósper, Jan Brülle, Franco Locatelli, Andreas Kremer, Marie José Kersten, Norbert Ifrah, Ulrike Koehl, Kristin Reiche, Robin Doeswijk, Martina Schüßler‐Lenz, Javier Briones, Maik Luu, Christian J. Buchholz, Jurgen H. E. Kuball, Emmanuel Donnadieu, Carmen Sanges, Dirk Hans Busch, Bruno Quesnel, Monica Casucci, Delphine Ammar, Chiara Bonini, Anna Sureda, Paul Franz, Christophe Ferrand, David Henderson, Leopold Sellner, Frederick W. Thielen, Jacquelyn Awigena-Cook, Inga Schapitz, Maria Luisa D'Amore, Ulf Grawunder, Michael Hudecek, Maria Thermeli, Carin Uyl-de Groot, Judith Theelen
article en

Abstract

With the proposal for major reform of the pharmaceutical legislation (Regulation (EU) 2023/0131, Directive (EU) 2023/0132) in April 2023, the foundations of Europe's regulatory architecture are being reshaped. The revised legislation proposes the removal of specialized committee functions (e.g., Committee for Advanced Therapies-CAT) by integrating their remit into other regulatory bodies, such as the Pharmacovigilance Risk Assessment Committee (PRAC) and Committee for Medicinal Products for Human Use (CHMP) and expert working groups. This decision may further challenge innovation in Europe, particularly in the field of advanced therapy medicinal products (ATMPs), which has already experienced a notable decline in global clinical trial activity over the past decade. This article emphasizes the importance of involving multistakeholder consortia such as T2EVOLVE in shaping pharmaceutical legislation to prevent the loss of specialized knowledge and the need for robust mechanisms that preserve developers' access to ATMP regulatory expertise.

CytotherapyVol. 28(1)
Centre National de la Recherche Scientifique (FR), Miltenyi Biotec (Germany) (DE), Vita-Salute San Raffaele University (IT), Inserm (FR), Bristol-Myers Squibb (Germany) (DE), Université Paris Cité (FR), University of Würzburg (DE), Hospital de Sant Pau (ES), European Hematology Association (NL), University Medical Center Utrecht (NL), Medizinische Hochschule Hannover (DE), Universitäts-Kinderklinik Würzburg (DE), Institut Català d'Oncologia (ES), Luxembourg Institute of Science and Technology (LU), Bambino Gesù Children's Hospital (IT), Bristol-Myers Squibb (United Kingdom) (GB), Universitätsklinikum Würzburg (DE), Clinica Universidad de Navarra (ES), Takeda (Germany) (DE), Institute of Medical Microbiology and Hygiene (DE), Institut Cochin (FR), Fraunhofer Institute for Cell Therapy and Immunology (DE), Institut National du Cancer (FR), Lymphoma Study Association (FR), Bristol-Myers Squibb (Italy) (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Astellas Pharma (Netherlands) (NL), Arbed (Luxembourg) (LU), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), Takeda (Japan) (JP), Technical University of Munich (DE), Bayer (Germany) (DE), Paul Ehrlich Institut (DE), Erasmus University Rotterdam (NL)
AstraZeneca, Gilead Sciences, Celgene, National Institute for Health and Care Excellence, European Federation of Pharmaceutical Industries and Associations, European Commission, Bundesamt für Gesundheit, Ministerie van Volksgezondheid, Welzijn en Sport
Openalex Percentile: Top 67%
Biomedical Ethics and Regulation
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