Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Japanese PI Waiver Good News to Mega Pharma and Emerging Players Alike: Pfizer Execs
The Japanese government’s policy change in late 2023 to no longer require Japanese PI studies before multiregional clinical trials, except when deemed necessary, will benefit not only mega pharma companies but also emerging biopharmas, says senior officials of Pfizer Japan.…
To read the full story
Related Article
- MHLW to Clarify Criteria for Japanese PI Waivers through Q&A, Calls for Data-Based Justifications
October 14, 2025
- PMDA Stresses Science-Based Decisions on Japanese PI Waivers: Symposium
August 5, 2025
- PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
July 10, 2025
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- Japan Officially Drops Japanese PI Requirement before Global Trial Entry
December 26, 2023
- Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
- Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
August 8, 2023
BUSINESS
- Eisai Eyes 1 Trillion yen in FY2028 Sales under 3-Year Plan
May 26, 2026
- Nippon Kayaku to Take Over AstraZeneca’s Zoladex in Japan
May 26, 2026
- Jardiance Triumphs in Six Promotion Channels in April: Intage
May 26, 2026
- NTT Data, Kindai Hospital Validate RWD-Based Patient Screening Technology
May 26, 2026
- Enhertu Earns EMA Panel OK for HER2 Positive Solid Tumors
May 25, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…