The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
PMDA to Clarify Position on Japanese PI Trials at August Symposium amid Industry Confusion
A 2023 regulatory guidance on the need for Japanese PI trials prior to global studies appears to have led to some confusion in the industry. With some taking this as a blanket waiver, the Pharmaceuticals and Medical Devices Agency (PMDA)…
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
- JPMA to Investigate the Status of Application of Japanese PI Waiver
April 22, 2025
- Japanese PI Waiver Good News to Mega Pharma and Emerging Players Alike: Pfizer Execs
January 21, 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
REGULATORY
- Japan Panel to Review Pfizer’s Cancer Med Tukysa on January 29
January 16, 2026
- Study Group Calls for Independent Body to Centrally Manage Whole Genome Data
January 16, 2026
- Expert Calls for Full Verification of CEA Guidelines and Analytical Frameworks
January 16, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
January 14, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…