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  • No.145, Jan.29.2015

  • Conditional, Time-Limited Approval

    条件・期限付き承認

The Pharmaceuticals and Medical Devices Law (薬機法; yakkiho) came into force in November 2014. The law created a new product category called “regenerative medicine products etc.”/“regenerative medicinal products etc.” (再生医療等製品; saisei iryo to seihin), which encompasses regenerative and cellular therapies ...


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G1/G2 Rule G1/G2ルール
New PMP Criteria 新薬創出加算の新要件
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
Price Maintenance Premium 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

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