(Early post-marketing phase) all-case surveillance
(市販直後)全例調査

Certain new drugs, such as those applied for based on data from no or a small number of patients enrolled in domestic clinical trials and those which present high risk of serious adverse reactions, are approved on the condition that...

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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
March 9, 2018
New PMP Criteria新薬創出加算の新要件
March 9, 2018
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

Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests

By Takashi Ebisawa

The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…

COLUMN

AI: Your New HR BFF (Not Your Replacement!)

By Philip Carrigan

Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…

COMMENTARY

Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise

By Koji Shimomura

Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…