Sakigake (drug designation)

Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the Pharmaceuticals and Medical Devices Agency, the pharmaceuticals regulator of Japan. It was designed to provide easier access to novel advanced treatments.[1] It is analogous to the Regenerative Medicine Advanced Therapy designation in the United States and the Advanced Therapy Medicinal Product designation in the European Union.

History

The Sakigake designation was first announced as a pilot by the Ministry of Health, Labour and Welfare on 17 June 2014. The designation system is part of a wider strategy, also named Sakigake, to promote R&D and improve access to new pharmaceuticals.[2] The Pharmaceutical & Medical Device Act Amendments of 2019, which entered into force on 1 September 2020, made the Sakigake designation system a permanent fixture.[3] While application for the Sakigake designation was only open for a short period every year, the permanent Sakigake regime is open year-round.

Effect

The Sakigake designation opens up the possibility for sponsors to seek pre-application consultations, which provide clients with a fixed-price multi-track review of their application.[4]

Statistics

As of 31 December 2020, 24 drugs received Sakigake designation, but only 8 of these (33.33%) were approved.[3]

References
  1. Kondo, Hideyuki; Hata, Toshiyuki; Ito, Konomi; Koike, Hisashi; Kono, Noriatsu (2017-01-01). "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. 51 (1): 51–54. doi:10.1177/2168479016662682. ISSN 2168-4790. PMID 30235998. S2CID 52306981.
  2. Pharmaceuticals and Medical Devices Agency. "Strategy of SAKIGAKE". www.pmda.go.jp. Ministry of Health, Labour and Welfare. Retrieved 2021-07-02.{{cite web}}: CS1 maint: url-status (link)
  3. Ikeda, Akiko (2020-11-24). "Sakigake System: From Pilot to Permanent Summary and Impact of Pharmaceutical & Medical Device Act Amendments in Japan". DIA Global Forum. Retrieved 2021-07-02.{{cite web}}: CS1 maint: url-status (link)
  4. "Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products". BioInsights. Retrieved 2021-07-02.


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