title: ATMPs for Cancer Immunotherapy: A Regulatory Overview.
abstract: This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.
authors.affiliation: Department of Cell Biology and Neurosciences, Istituto Superiore di Sanità, 299, Viale Regina Elena, Roma, Italy. mariacristina.galli@iss.it.
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Galli
mesh_terms: D002986:Clinical Trials as Topic; D005060:Europe; D006801:Humans; D007167:Immunotherapy / Q000331:legislation & jurisprudence*; D009369:Neoplasms / Q000628:therapy*
keywords: Advanced therapy medicinal products; Cancer immunotherapy; Clinical trials; European regulations; Translation