Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe
Year: 2025
Type: article
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.
Source: Cytotherapy
Authors: Delphine Ammar, Carmen Sanges, David Henderson, Inga Schapitz, Michael Hudecek, Maik Luu, Martina Schüssler-Lenz, Christian Buchholz, Paul Franz, Kristin Reiche, Ulrike Köhl, Norbert Ifrah, Bruno Quesnel, Maria Thermeli, Marie Jose Kersten, Franco Locatelli, Maria Luisa D'Amore, Chiara Bonini, Monica Casucci, Ulrike Philippar, Robin Doeswijk, Frederick Thielen, Carin Uyl - de Groot, Judith Theelen, Bernd Schröder, Andreas Kremer, Maria Quaranta, Felipe Prosper, Jan Van den Brulle, Ulf Grawunder, Emmanuel Donnadieu, Anne GALY, Christophe Ferrand, Nina Worel, Dirk Busch, Javier Briones, Leopold Sellner, Jurgen Kuball, Anna Sureda, Jacquelyn Awigena-Cook
Institutions: Astellas Pharma (Netherlands), Universitätsklinikum Würzburg, Bayer (Germany), University of Würzburg, Paul Ehrlich Institut, Fraunhofer Institute for Cell Therapy and Immunology, Medizinische Hochschule Hannover, Leipzig University, Institut National du Cancer, Bambino Gesù Children's Hospital, Istituti di Ricovero e Cura a Carattere Scientifico, IRCCS Ospedale San Raffaele, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, European Hematology Association, Erasmus University Rotterdam, Miltenyi Biotec (Germany), Clinica Universidad de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Centro de Investigación Médica Aplicada, Centre National de la Recherche Scientifique, Inserm, Université Paris Cité, Institut Cochin, Technical University of Munich, University Medical Center Utrecht, Institut Català d'Oncologia, Bristol-Myers Squibb (United Kingdom)
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,300
Funders: AstraZeneca, Gilead Sciences, Celgene, European Hematology Association, 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, Innovative Medicines Initiative, Horizon 2020 Framework Programme
OpenAlex ID: W4414480035