[International comparison and regulatory issues of the molecular targeted therapy development].
In July 2013 from the Ministry of Health, Labour and Welfare of Japan notified "Approval application for in vitro companion diagnostics and corresponding therapeutic products" (manager notification). They recommended concurrent development of molecular targeted therapies and companion diagnostics. However, there are specific difficulties; cooperation between diagnostic company and pharmaceutical company, indeterminacy of profitability outlook etc. Moreover, it is also a problem how to supervise and to secure the quality and safety of the examination. In the future, multiplex diagnostic examination, which detect multiple molecular targets abnormalities at once, is developed commercially. In this paper, we outline the issues as well as international comparison in the current state of the approval and application system.
Masahiro
M
Iwasaku
Koji
K
Kawakami
D014408:Biomarkers, Tumor; D017277:Drug Approval; D055808:Drug Discovery; D006801:Humans; D038622:Internationality; D058990:Molecular Targeted Therapy / Q000592:standards / Q000639:trends; D011933:Reagent Kits, Diagnostic
D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic