title: Cell-based product classification procedure: What can be done differently to improve decisions on borderline products?
abstract: In June 2015, European Medicines Agency/Committee for Advanced Therapies (CAT) released the new version of the reflection paper on classification of advanced therapy medicinal products (ATMPs) established to address questions of borderline cases in which classification of a product based on genes, cells or tissues is unclear. The paper shows CAT's understanding of substantial manipulation and essential function(s) criteria that define the legal scope of cell-based medicinal products. This article aims to define the authors' viewpoint on the reflection paper. ATMP classification has intrinsic weaknesses derived from the lack of clarity of the evolving concepts of substantial manipulation and essential function(s) as stated in the EU Regulation, leading to the risk of differing interpretations and misclassification. This might result in the broadening of ATMP scope at the expense of other products such as cell/tissue transplants and blood products, or even putting some present and future clinical practice at risk of being classified as ATMP. Because of the major organizational, economic and regulatory implications of product classification, we advocate for increased interaction between CAT and competent authorities (CAs) for medicines, blood and blood components and tissues and cells or for the creation of working groups including representatives of all parties as recently suggested by several CAs.
authors.affiliation: Tissue Engineering Laboratory, Bioengineering Area, Instituto Biodonostia, Hospital Universitario Donostia, San Sebastián, Spain.
authors.forename: Ander
authors.initials: A
authors.lastname: Izeta
authors.affiliation: Cell and Gene Therapy Unit, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, GMP Network of the Andalusian Initiative for Advanced Therapies, Córdoba, Spain.
authors.forename: Concha
authors.initials: C
authors.lastname: Herrera
authors.affiliation: Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Sevilla, Spain.
authors.forename: Rosario
authors.initials: R
authors.lastname: Mata
authors.affiliation: Advanced Cellular Therapy Laboratory, Department of Cellular Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Astori
authors.affiliation: Cell Factory, Unit of Cell Therapy and Cryobiology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Rosaria
authors.initials: R
authors.lastname: Giordano
authors.affiliation: Cell Therapy Unit, Blood Bank of Malaga, Servicio Andaluz de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Málaga, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Hernández
authors.affiliation: Cell Therapy Unit, Hospital Universitario Regional de Málaga, IBIMA, GMP Network of the Andalusian Initiative for Advanced Therapies, Málaga, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Leyva
authors.affiliation: Cell Therapy and Tissue Engineering Unit, Complejo Hospitalario de Granada, GMP Network of the Andalusian Initiative for Advanced Therapies, Granada, Spain.
authors.forename: Salvador
authors.initials: S
authors.lastname: Arias
authors.affiliation: Cell Therapy Unit, Blood Bank of Seville, Servicio Andaluz de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Sevilla, Spain.
authors.forename: Salvador
authors.initials: S
authors.lastname: Oyonarte
authors.affiliation: Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Sevilla, Spain; Cell Therapy and Cell Reprogramming Unit, Consejería de Salud, GMP Network of the Andalusian Initiative for Advanced Therapies, Seville, Spain.
authors.forename: Gloria
authors.initials: G
authors.lastname: Carmona
authors.affiliation: Andalusian Initiative for Advanced Therapies, Junta de Andalucía, Sevilla, Spain; Andalusian Transplant Coordination, Servicio Andaluz de Salud, Sevilla, Spain. Electronic address: natividad.cuende.sspa@juntadeandalucia.es.
authors.forename: Natividad
authors.initials: N
authors.lastname: Cuende
mesh_terms: D003657:Decision Making; D006801:Humans; D019737:Transplants / Q000145:classification*
keywords: accessibility; blood cell transfusion; cell transplantation; cell-based borderline products; cell-based medicinal products; classification procedure; essential functions; regulation; substantial manipulation; sustainability