Priority review
優先審査
Fast-track review
迅速（承認）審査

Priority review (優先審査) status is given to drugs/medical devices designated as orphan drugs/medical devices (希少疾病用医薬品/医療用具) and those indicated for serious diseases or those whose efficacy and/or safety are apparently superior to that of existing drugs/medical devices. Applications for marketing approval...

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LEXICON

Elective Care Scheme for LLPs長期収載品選定療養制度
July 19, 2024
G1/G2 RuleG1/G2ルール
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Cost-Based Method原価計算方式
July 27, 2017
Sakigake Designation Scheme先駆け審査指定制度
August 17, 2016

Chuikyo Debate on FY2026 Drug Pricing Reform

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COMMENTARY

Elevidys Opens New Era for DMD Treatments Targeting the Underlying Cause

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COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…