The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States

Therapeutic Innovation & Regulatory Science
Hideyuki KondoNoriatsu Kono

Abstract

Following the Breakthrough Therapy Designation system in 2012 in the United States, the Sakigake Designation was introduced in 2015 in Japan, and PRIME (PRIority MEdicines) was started in 2016 in the European Union. Each system aims at giving patients better access to innovative drugs and regenerative medicine products by providing product developers with generous regulatory and scientific support from an early development stage. So far, the designation systems have operated independently in each region, and no products with the same indication have been designated commonly under the 3 designation systems. However, no designation system excludes a product designated under another system, which allows the possibility of an applicant to seek all 3 designations; this may happen in the near future. Therefore, an understanding of the current situation under each designation system will contribute to effective operation of each system as well as identification of further collaborative activities between the European Medicines Agency; Japan's Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency; and the United States Food and Drug Administration. Such collaborations can be successful because these organiza...Continue Reading

Citations

May 8, 2018·Therapeutic Innovation & Regulatory Science·Makoto TanakaKatsura Tsukamoto
Dec 21, 2018·Journal of Medical Internet Research·Ching LamZhanfeng Cui
Jun 21, 2018·Clinical Pharmacology and Therapeutics·Philippe SerranoChristine Mayer-Nicolai
Oct 23, 2019·Immunotherapy·Jacqueline R HwangTimothy Craig
Dec 12, 2019·Future Oncology·Pan PantziarkaLydie Meheus
Mar 12, 2021·British Journal of Clinical Pharmacology·Mototsugu TanakaMutsuhiro Ikuma
Dec 18, 2021·Journal of Medical Economics·Mihajlo JakovljevicTakuma Sugahara

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