title: Cancer drug development and the evolving regulatory framework for companion diagnostics in the European union.
abstract: The European Union (EU) legal framework for medical device regulation is currently under revision. The European Commission has proposed a new framework to ensure that medical devices serve the needs and ensure the safety of European citizens, aiming for a framework that is fit for purpose, more transparent, and better adapted to scientific and technological progress. The proposed new framework is described as an evolution of the current regime keeping the same legal approach. An important proposed change is that companion diagnostics will no longer be considered as low risk and subject to self-certification by the manufacturer. According to the new proposal, companion diagnostics will be classified as high individual risk or moderate public health risk (category C) and require conformity assessment by a notified body. It has also been proposed that evidence of the clinical utility of the device for the intended purpose should be required for companion diagnostics. In this article, we review the EU legal framework relevant for companion diagnostics, describe the proposed changes, and summarize the available scientific guidance from the European Medicines Agency and its regulatory experience with cancer drug development including companion diagnostics. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development."
authors.affiliation: Authors' Affiliations: The European Medicines Agency; Medicines and Healthcare Products Regulatory Agency, London, United Kingdom; Medical Products Agency, Uppsala, Sweden; Paul-Ehrlich-Institut, Langen, Germany; and Medical University of Vienna, Vienna, Austria.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
authors.forename: Falk
authors.initials: F
authors.lastname: Ehmann
authors.forename: Robert
authors.initials: R
authors.lastname: Hemmings
authors.forename: Bertil
authors.initials: B
authors.lastname: Jonsson
authors.forename: Micha
authors.initials: M
authors.lastname: Nuebling
authors.forename: Marisa
authors.initials: M
authors.lastname: Papaluca-Amati
authors.forename: Martin
authors.initials: M
authors.lastname: Posch
authors.forename: Guido
authors.initials: G
authors.lastname: Rasi
mesh_terms: D000970:Antineoplastic Agents / Q000592:standards*; D005062:European Union; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000592:standards*; D058990:Molecular Targeted Therapy / Q000592:standards*; D009369:Neoplasms / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents