Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
JPMA Official Renews Call for Use of “Specified Clinical Research” Data in Application Dossiers
A senior official of the Japan Pharmaceutical Manufacturers Association (JPMA) has reiterated the trade group’s push for the use of data from what is called “specified clinical research (tokutei rinsho kenkyu)” in early-stage trials and the conditional early approval system…
To read the full story
Related Article
- MHLW’s Panel Compiles Interim Paper for Promotion of Clinical Research, Trials
March 14, 2019
- HSC Panel Discusses Data Standardization to Promote Use of Real World Data
February 19, 2019
- “Detailed Discussions” Necessary for Use of Real World Data: HSC Panel
January 25, 2019
- 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
- Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
March 23, 2017
REGULATORY
- Panel Backs RSV Antibodies for Japan’s Routine Immunization Program
October 23, 2026
- Japan Weighs Possible Approval Revocation for Tavneos, Action Against Kissei
October 22, 2026
- Hernexeos, Rinvoq, Tukysa Label Expansions Now in Line for Japan Approval
October 22, 2026
- LDP, Ishin Resume Social Security Talks, Chuikyo Reform to Follow
October 22, 2026
- LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
October 20, 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…