Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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
- Lp(a) Drugs Face Next Test in Quest to Cut Cardiovascular Risk
October 19, 2026
- Japan Moves to Break Plasma Product Capacity Crunch with Factory Aid
October 6, 2026
- Survodutide Could Carve Out Role in MASH as Next-Gen Dual Agonist
September 28, 2026
- Regional Formularies Gain Ground, Raising Stakes for Drug Makers, Wholesalers
September 15, 2026
- As US Pushes Global Cost Rebalancing, Can Japan Answer with Drug Prices?
September 7, 2026
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…