REGULATORY

MHLW Reiterates Caution on Skin Disorders for Lamictal: Safety Bulletin

March 31, 2015

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The Ministry of Health, Labor and Welfare (MHLW) issued a pharmaceutical safety information bulletin on March 30, calling on physicians to stick to the approved dosage and administration for GlaxoSmithKline K.K.’s (GSK) antiepileptic agent Lamictal (lamotrigine). GSK issued a flash…

To read the full story

GSK Ordered to Issue Blue Letter on Lamictal
February 5, 2015

REGULATORY

Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
March 5, 2026

Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

COMMENTARY

G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands

By Shinya Sato

Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

COLUMN

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

By Philip Carrigan

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…