Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
REGULATORY
Tap Data from “Specified Clinical Research” for Early Trial, Conditional Approval: JPMA Official
The pharma industry is hoping to utilize data from what is called “specified clinical research (tokutei rinsho kenkyu)” for early-stage clinical trials and the conditional early approval system, an official of the Japan Pharmaceutical Manufacturers Association (JPMA) said on April…
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
- Use “Specified Clinical Research” Data for Drug Approval: Regulatory Science Society
March 23, 2017
REGULATORY
- PMDA Halts Medical Device Application Platform after Unauthorized Access
October 30, 2026
- Drug Makers Can Refuse Diabetes Drug Supply over Improper Prescribing: JFTC
October 30, 2026
- Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
October 29, 2026
- FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
October 29, 2026
- Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
October 29, 2026
The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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…
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…