title: Regulatory approval pathways for anticancer drugs in Japan, the EU and the US.
abstract: The Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan and the US Food and Drug Administration are responsible for reviewing applications and approving drugs, medical devices, and regenerative medicines. In the EU, the European Medicines Agency is responsible for the centralized authorization procedure of medicines including oncologic drugs. In this review, we discuss general pathways for the marketing authorization of oncologic drugs and other drugs in Japan, the EU, and the US. There are still unmet medical needs in oncology, whereas scientific innovation and clinical development in oncology are rapid and active, suggesting a reasonable scope for new regulatory schemes for expedited review. Because regulatory schemes are also evolving rapidly, clinicians and academic researchers may have difficulty following the updated regulations in other regions as well as those in their own countries. However, keeping current with new regulations is important for the conduct of translational research and clinical development of new therapeutic products efficiently. This review is intended to help an international audience better understand the essence of the regulatory frameworks for the marketing authorization of oncologic drugs in Japan, the EU, and the US.
authors.affiliation: Division of Genetic Therapeutics, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo, 1088639, Japan. sunagai-tky@umin.ac.jp.
authors.forename: Sumimasa
authors.initials: S
authors.lastname: Nagai
authors.affiliation: Division of Genetic Therapeutics, The Advanced Clinical Research Center, The Institute of Medical Science, The University of Tokyo, 4-6-1, Shirokanedai, Minato-ku, Tokyo, 1088639, Japan.
authors.forename: Keiya
authors.initials: K
authors.lastname: Ozawa
mesh_terms: D000970:Antineoplastic Agents; D017277:Drug Approval / Q000379:methods*; D004335:Drug and Narcotic Control / Q000379:methods; D005062:European Union; D006801:Humans; D007564:Japan; D014481:United States
chemical_list: D000970:Antineoplastic Agents
keywords: EMA; FDA; PMDA; Regulation