Sakigake (drug designation)
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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
[edit]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
[edit]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
[edit]As of 31 December 2020[update], 24 drugs received Sakigake designation, but only 8 of these (33.33%) were approved.[3]
References
[edit]- ^ 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.
- ^ Pharmaceuticals and Medical Devices Agency. "Strategy of SAKIGAKE". www.pmda.go.jp. Ministry of Health, Labour and Welfare. Retrieved 2021-07-02.
- ^ a b 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.
- ^ "Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products". BioInsights. Retrieved 2021-07-02.
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