Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
eCTD Progresses to Step 4 at ICH in Brussels
M8 (Electronic Common Technical Document or eCTD) progressed to Step 4 at the 26th International Conference on Harmonization (ICH) held June 1-6 in Brussels, Belgium. Going forward, each country is expected to begin procedures to incorporate the eCTD in their…
To read the full story
Related Article
REGULATORY
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Expert Calls for AMR Ecosystem to Boost Japan Antibiotic Innovation
June 25, 2026
- PMDA Eyes AI as Staffing Shortages Affect Orphan Drug Reviews
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…