Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- MSD Launches RSV Antibody Enflonsia in Japan without NHI Listing
August 24, 2026
- Sumitomo Pharma Eyes Global Position as Adjuvant Supplier
August 24, 2026
- Oncolys’ Oncolytic Virus Telomelysin Hits Japan Market
August 24, 2026
- Sobi’s Still’s Disease Drug Kineret Now Available in Japan
August 24, 2026
- MSD Files Welireg-Keytruda Combo in Japan for Adjuvant RCC
August 24, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…