Call for preserving specialized knowledge and contributions of the CAT to advancing ATMPs in Europe
Por:
Ammar, D, Sanges, C, Henderson, D, Schapitz, I, Hudecek, M, Luu, M, Schüssler-Lenz, M, Buchholz, C, Franz, P, Reiche, K, Köhl, U, Ifrah, N, Quesnel, B, Thermeli, M, Kersten, MJ, Locatelli, F, D'Amore, ML, Bonini, C, Casucci, M, Philippar, U, Doeswijk, R, Thielen, F, Uyl-de Groot, C, Theelen, J, Schröder, B, Kremer, A, Quaranta, M, Prosper, F, Van den Brulle, J, Grawunder, U, Donnadieu, E, Galy, A, Ferrand, C, Worel, N, Busch, D, Briones, J, Sellner, L, Kuball, J, Sureda, A, Awigena-Cook, J
Publicada:
1 ene 2026
Ahead of Print:
1 ene 2026
Resumen:
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.
Filiaciones:
Ammar, D:
Astellas Pharm BV, Leiden, Netherlands
Sanges, C:
Univ Klinikum Wurzburg, Lehrstuhl Zellulare Immuntherapie, Med Klin & Poliklin 2, Oberdurrbacher Str 6, D-97080 Wurzburg, Germany
Henderson, D:
Bayer AG, Berlin, Germany
Schapitz, I:
Bayer Vital GmbH, Leverkusen, Germany
Hudecek, M:
Univ Klinikum Wurzburg, Lehrstuhl Zellulare Immuntherapie, Med Klin & Poliklin 2, Oberdurrbacher Str 6, D-97080 Wurzburg, Germany
Luu, M:
Univ Klinikum Wurzburg, Lehrstuhl Zellulare Immuntherapie, Med Klin & Poliklin 2, Oberdurrbacher Str 6, D-97080 Wurzburg, Germany
Schüssler-Lenz, M:
Paul Ehrlich Inst, Mol Biotechnol & Gene Therapy, Langen, Germany
Paul Ehrlich Inst, Haematol Cell & Gene Therapy, D-63225 Langen, Germany
Buchholz, C:
Paul Ehrlich Inst, Mol Biotechnol & Gene Therapy, Langen, Germany
Franz, P:
Fraunhofer Inst Cell Therapy & Immunol, Leipzig, Germany
Reiche, K:
Fraunhofer Inst Cell Therapy & Immunol, Leipzig, Germany
Köhl, U:
Univ Leipzig, Inst Clin Immunol, Leipzig, Germany
Hannover Med Sch, Inst Cellular Therapeut, Hannover, Germany
Ifrah, N:
Inst Natl Canc, Paris, France
Quesnel, B:
Inst Natl Canc, Paris, France
Thermeli, M:
LYMMCARE Lymphoma & Myeloma Ctr Amsterdam, Amsterdam, Netherlands
Kersten, MJ:
LYMMCARE Lymphoma & Myeloma Ctr Amsterdam, Amsterdam, Netherlands
Locatelli, F:
IRCCS Bambino Gesu Childrens Hosp, Dept Pediat Hematol Oncol & Cell & Gene Therapy, Rome, Italy
Bonini, C:
IRCCS San Raffaele Sci Inst, Div Immunol Transplantat & Infect Dis, Innovat Immunotherapies Unit, Milan, Italy
Casucci, M:
IRCCS San Raffaele Sci Inst, Div Immunol Transplantat & Infect Dis, Innovat Immunotherapies Unit, Milan, Italy
Philippar, U:
European Hematol Assoc, The Hague, Netherlands
Doeswijk, R:
European Hematol Assoc, The Hague, Netherlands
Thielen, F:
Erasmus Univ, Erasmus Sch Hlth Policy & Management, Rotterdam, Netherlands
Theelen, J:
Miltenyi Botec BV & CO KG, Bergisch Gladbach, Germany
Schröder, B:
Miltenyi Botec BV & CO KG, Bergisch Gladbach, Germany
Kremer, A:
Informat Technol Translat Med ITTM SA, Esch Sur Alzette, Luxembourg
Quaranta, M:
Informat Technol Translat Med ITTM SA, Esch Sur Alzette, Luxembourg
Prosper, F:
Clin Univ Navarra, Hematol & Cell Therapy Dept, Hematooncol Program, Pamplona, Spain
Clin Univ Navarra CCUN, Ctr Invest Biomed Red Canc CIBERONC, Canc Ctr, Pamplona, Spain
Grawunder, U:
T CURX GMBH, Wurzburg, Germany
Donnadieu, E:
Univ Paris Cite, Inst Cochin, Equipe Labellisee Ligue Canc, CNRS,INSERM, Paris, France
Galy, A:
Univ Paris Cite, Inst Cochin, Equipe Labellisee Ligue Canc, CNRS,INSERM, Paris, France
Ferrand, C:
Univ Paris Cite, Inst Cochin, Equipe Labellisee Ligue Canc, CNRS,INSERM, Paris, France
Worel, N:
T CURX GMBH, Wurzburg, Germany
Busch, D:
Tech Univ Munich, Inst Med Microbiol Immunol & Hyg, Munich, Germany
Briones, J:
Inst Invest Biomed St Pau IIB St Pau, Serv Hematol, Barcelona, Spain
Sureda, A:
Inst Catala Oncol, Barcelona, Spain
Awigena-Cook, J:
Bristol Myers Squibb, Global Regulatory Sci, Uxbridge UB8 1DH, England
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