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Ther Innov Regul Sci. 2017 Jan;51(1):51-54. doi: 10.1177/2168479016662682. Epub 2016 Sep 27.

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

Author information

1 Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
2 Office of Review Management, Pharmaceuticals and Medical Devices Agency.
3 Coordination Officer for Review of Breakthrough Products (Sakigake), Pharmaceuticals and Medical Devices Agency.


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 organizations have already established a close relationship through international activities such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Coalition of Medicines Regulatory Authorities (ICMRA).


Breakthrough Therapy Designation; EMA; PMDA; PRIME; Sakigake


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