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
- Astellas Expands AI Drug Discovery to TPDs, Engineered Proteins
July 30, 2026
- Regeneron Japan Files First Dual-AAV Therapy for Genetic Hearing Loss
July 30, 2026
- Shionogi’s Xocova Debuts in US for COVID-19 PEP
July 30, 2026
- Some Drug Plants Halt Operations after Kumamoto Temblor, Supplies Unaffected
July 30, 2026
- Leqembi Global Sales Rise to 29.3 Billion Yen in April-June: Eisai
July 30, 2026
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…