Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- PMDA Urges Proper Use of Colchicine, Advises against High-Dose Administration
February 12, 2026
- PMDA to Offer Priority Consultations for Overseas Startups
February 12, 2026
- Japan OKs 2nd OTC Emergency Contraceptive, Launch Set for March 9
February 12, 2026
- LDP Wins Landslide Victory in Lower House Election; Ex-Lawmakers Return as Centrists Routed
February 9, 2026
- MHLW Panel Deems 10 “Drug Loss” Products as High-Need, to Seek Development
February 9, 2026
Japan’s health and finance ministers agreed late last year to go ahead with an “off-year” drug price revision in FY2027,…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…