REGULATORY
Approve 16 Pediatric Cancer Meds as Exceptional Step Beyond Law, Oncologist Urges
Japanese regulators should immediately green-light the pediatric use of 16 cancer drugs approved for adults in Japan that carry indications for children in the US as a special measure that goes beyond the existing laws and regulations, a clinical oncologist…
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
- Japan to Basically Drop Japanese PI Requirement before Global Clinical Trials
September 14, 2023
REGULATORY
- MHLW Pharma Director Says Uniform Drug Price Hike “Not Realistic,” Targeted Support Preferred
January 9, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
January 6, 2026
- Ex-JPMA President Ueno Takes on New AMED Advisor Role
January 6, 2026
- Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
January 5, 2026
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…





