LEXICON

• Cabinet-initiated bill閣法
  Lawmaker-initiated bill; legislation introduced by Diet members議員立法
  March 26, 2012

• “True” clinical benefits真の臨床的有用性
  Usefulness or utility有用性（日本の臨床試験において）
  March 19, 2012

• Drug marketing license (authorization) holder; drug marketer医薬品製造販売業者
  First-class drug marketing license (authorization) holder; first-class drug marketer第１種医薬品製造販売業者
  Second-class drug marketing license (authorization) holder; second-class drug marketer第２種医薬品製造販売業者
  March 12, 2012

• Japan Pharmaceutical Political Association日本薬業政治連盟
  Seiyaku Sangyo Seiji Renmei製薬産業政治連盟
  March 5, 2012

• Basic hospitalization fee for hospitals with a 7：1 patient to nurse ratio7対1入院基本料
  7 to 1 nursing care7対1看護
  February 20, 2012

• In vitro diagnostic (IVD); extracorporeal diagnostic (agent)体外診断薬(体外診断用医薬品)
  In vivo diagnostic (agent)体内診断薬
  Laboratory study; clinical test; clinical assay臨床検査
  Laboratory (lab) test検体検査
  Physiological function test生理機能検査
  February 13, 2012

• Ordinary NHI price revision; price revision based on market prices通常改定
  Re-pricing following market expansion市場拡大再算定
  Special (extraordinary) price cut (reduction)特例引き下げ
  Ad hoc (additional) NHI price cut追加引き下げ
  February 6, 2012

• Foreign exceptional approval system外国特例承認制度
  Appointed marketing authorization holder選任製造販売業者
  January 30, 2012

• Antedrugアンテドラッグ
  Prodrugプロドラッグ
  January 23, 2012

• Regulatory strategy consultation薬事戦略相談
  January 16, 2012

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