Japan’s contract drug rep ratio rose to 8.7% in FY2024 as the total number of regular reps continued to fall, the Japan Contract Sales Organization Association (JCSOA) reported in June. Amid industry downsizing, the roles and expectations placed on contract…
REGULATORY
Japan Officially Drops Japanese PI Requirement before Global Trial Entry
Japan’s health ministry on December 25 clarified its position that additional PI studies in Japanese subjects prior to the country’s participation in multiregional clinical trials (MRCTs) are “not needed” as a general rule. The Ministry of Health, Labor and Welfare…
To read the full story
Related Article
- 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 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
- Public-Private Council WG on Drug Discovery to Hold First Meeting Sept. 1
August 26, 2025
- Japan Approves 3 New Drugs, Expands Label for Enhertu, Silgard 9 and More
August 26, 2025
- No Inflation Measures for Drugs Mentioned in FY2026 Budget Request: MHLW Draft
August 25, 2025
- MHLW Panel Endorses Orphan Tag for 2 Regenerative Medicine Products
August 25, 2025
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
A recent conversation with a US biopharma senior director highlighted a critical talent gap: a strong demand for individuals with strategic management, critical thinking, and advanced business acumen-skills beyond traditional operational excellence. After the conversation, I rushed home and picked…
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 key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…
A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…
The Ministry of Health, Labor and Welfare (MHLW) posted the final report compiled by its pharmaceutical regulation panel on its website on April 24, providing cases of drugs that could be exempted from all-case post marketing surveillance (PMS).The MHLW plans…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…
The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…