Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe [* Cross-Reference *]

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Delphine Ammar; Carmen Sanges; David Henderson; Inga Schapitz; Michael Hudecek; Maik Luu; Martina Schüßler‐Lenz; Christian J. Buchholz; Paul Franz; Kristin Reiche; Ulrike Koehl; Norbert Ifrah; Bruno Quesnel; Maria Thermeli; Marie José Kersten; Franco Locatelli; Maria Luisa D'Amore; Chiara Bonini; Monica Casucci; Ulrike Philippar; Robin Doeswijk; Frederick W. Thielen; Carin Uyl-de Groot; Judith Theelen; Bernd Schröder; Andreas Kremer; Maria Quaranta; Felipe Prósper; Jan Brülle; Ulf Grawunder; Emmanuel Donnadieu; Anne Galy; Christophe Ferrand; Nina Worel; Dirk H. Busch; Javier Briones; Leopold Sellner; Jürgen Kuball; Anna Sureda; Jacquelyn Awigena-Cook, 2026, "Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe [* Cross-Reference *]", https://lore.list.lu/citation?persistentId=perma:LIST.KZVASI, LIST Open Repository, V1
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Description
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. (2025-09-24)
***This entry has been automatically imported via OpenAlex by LIST harvest scripts. Please refer to https://doi.org/10.1016/j.jcyt.2025.09.007 for the original and latest version of the publication*** (2026-07-01)
Subject Business and Management; Medicine, Health and Life Sciences; Social Sciences
Keyword Legislation, Directive, Regulatory affairs, Regulatory authority, Pharmacovigilance, Steering committee
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