Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
Will Legal Regulation Propel or Stymie Clinical Research? “Risk-Based” Approach Holds Key
The Ministry of Health, Labor and Welfare (MHLW) has begun drafting a bill for the legal regulation of clinical research conducted by academia and other research institutes. The move comes after a panel of experts released a report on December…
To read the full story
Related Article
- In a Flip-Flop, LDP Aims to Enact Clinical Research Bill in Current Diet Session
April 28, 2016
- Clinical Research Bill Won’t Be Enacted in Current Diet Session: LDP Health Panel Chief
March 30, 2016
- Difficult to Enact Clinical Research Bill in Current Diet Session: LDP Health Panel Chief
March 9, 2016
- LDP Legislators Discuss Legal Regulation of Clinical Research
April 1, 2015
COMMENTARY
- 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
- TSE’s Growth Market Reform Puts Pressure on Biotechs
January 27, 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…