Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
ORGANIZATION
Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
The Pharmaceutical and Medical Device Regulatory Science Society of Japan issued a proposal on March 22 calling for the use of data obtained from “specified clinical research (tokutei rinsho kenkyu),” defined in a bill currently under Diet deliberations, as part…
To read the full story
Related Article
- JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
December 7, 2018
- JPMA Official Hails MHLW Discussions on Use of “Specified Clinical Research” Data in Application Dossiers
September 10, 2018
- MHLW Discussing Use of Data from “Specified Clinical Research” in Application Dossiers, Will Issue Preliminary Conclusions by March
August 29, 2018
- Tap Data from “Specified Clinical Research” for Early Trial, Conditional Approval: JPMA Official
April 24, 2018
- “Specified Clinical Research” Data with High Integrity Could Be Used for Drug Review: MHLW Councilor
May 8, 2017
- MHLW to Mull Use of Data from “Specified Clinical Research” for Drug Review: Official
April 10, 2017
ORGANIZATION
- JPWA Reports No Damage from PHP Vulnerability, Renews “No” to FY2027 Revision
October 23, 2026
- Ex-JMA Vice President, Lawmaker Hanyuda Remembered at Memorial Service
October 21, 2026
- Japan Generics Society Calls for Risk-Based Nitrosamine Controls
October 16, 2026
- Japan Expert Calls for Earlier Access to Anti-Obesity Drugs
October 16, 2026
- Japan Falling Behind US, China in Pharma Innovation, EFPIA Chief Urges Action
October 15, 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…