Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
The Ministry of Health, Labor and Welfare (MHLW) plans to no longer require the implementation of additional PI clinical studies in Japanese subjects prior to later-stage multinational trials as a general rule. The regulator hopes this will help prevent lags…
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
- 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
- Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
August 8, 2023
REGULATORY
- AMED-Backed R&D Yielded 31 Regulatory Approvals in FY2025
July 17, 2026
- MHLW to Reconvene HSC Regulation Panel for First Time in a Year
July 17, 2026
- MHLW Allows Exceptional Concerta Pharmacy Transfers
July 17, 2026
- Japan to Consider Support for Domestic Immunoglobulin Production: Minister
July 16, 2026
- Govt Set to Amend Honebuto Draft over Inflation, MFN Language
July 16, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
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…