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
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Japan Grants First-Ever Approval to iPSC-Based Therapies
March 6, 2026
- Meiji Starts Japan PIII Trial of Rezurock for CLAD
March 6, 2026
- Meiji Rolls Out Rezurock in Taiwan
March 6, 2026
- Toray Out-Licenses Parkinson’s Drug to Immunis
March 6, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





