Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
With Study Group on Counterfeit Drugs to Resume Discussions this Fall, Full-Scale Discussions on Introduction of PIC/S GDP Guidelines Looming
By Tomoyuki Iwasaki The health ministry’s study group on counterfeit drugs will meet again this autumn. In its interim report announced in June, the study group noted that the establishment of domestic rules consistent with global PIC/S GDP guidelines on…
To read the full story
Related Article
- Counterfeit Drug Panel OKs Final Report, MHLW to Issue GDP Guidelines in FY2018
December 27, 2017
- MHLW Counterfeit Drug Panel Agrees on “Voluntary” Introduction of GDP in Japan
November 14, 2017
- MHLW Study Group Compile Draft Interim Report on Preventing Distribution of Counterfeit Drugs
June 12, 2017
COMMENTARY
- ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
March 9, 2026
- G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
February 25, 2026
- Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?
February 18, 2026
- Is Calling for an Abolition the Right Play? Rethinking Japan’s FY2027 Off-Year Drug Price Revision
February 9, 2026
- Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
February 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…