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  • No.153, Aug.17.2016

  • Sakigake Designation Scheme

    先駆け審査指定制度
Japan introduced the “sakigake” designation scheme (先駆け審査指定制度; sakigake shinsa shitei seido) on a pilot basis in 2015, aiming to accelerate the time to market for innovative drug candidates by giving them a series of privileges in both the pre-application and ...

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Cost Calculation Method 原価計算方式
Sakigake Designation Scheme 先駆け審査指定制度
Special expansion re-pricing (Huge-seller re-pricing) 特例拡大再算定(巨額再算定)
Market expansion re-pricing 市場拡大再算定
3 price-band (bracket) grouping rule 3価格帯ルール
Pricing premium for the promotion of new drug development and the elimination/resolution of off-label use 新薬創出・適応外薬解消等促進加算(新薬創出加算)
Z2 Rule Z2(ゼットツー)
Japan Agency for Medical Research and Development (AMED) 日本医療研究開発機構

Annual NHI Drug Price Revisions 毎年改定

Conditional, Time-Limited Approval 条件・期限付き承認

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