title: International differences in companion diagnostic approvals: how are we able to manage the differences?
abstract: One would expect regulations for drugs and diagnostics not to differ significantly between countries, given that regulatory authorities evaluate the same scientific data generated in an increasingly globally harmonized context. However, studies of our own and others have provided compelling evidence of differences in regulations for drugs and in vitro companion diagnostics in personalized medicine. Differing regulatory processes create hurdles for both pharmaceutical and companion diagnostics companies with different platforms that employ different technologies. The rising cost of healthcare caused by improvements in technology is another issue that faces all advanced countries. To address these issues and to facilitate access to personalized medicine, regulatory authorities, academia and the pharmaceutical industry should increase dialogue on the differences on an international platform.
authors.affiliation: Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Rumiko
authors.initials: R
authors.lastname: Shimazawa
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ikeda
mesh_terms: D015415:Biomarkers; D057069:Diagnostic Test Approval; D017277:Drug Approval; D004348:Drug Labeling; D006801:Humans; D007564:Japan; D057285:Precision Medicine; D006113:United Kingdom; D014481:United States
chemical_list: D015415:Biomarkers
keywords: US FDA; biomarkers; diagnostic test approval; drug approval; individualized medicine; pharmacogenetics