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
Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty
A third-party probe panel on December 2 reported an organizational cover-up found in the Chemo-Sero-Therapeutic Research Institute’s GMP violations over its blood products, lambasting the conduct as being “extremely malicious” and hinting at possible criminal charges. The Ministry of Health,…
To read the full story
Related Article
- Transfer of Vaccine, Blood Biz under Negotiation, All Directors to Exit in June: Kaketsuken
May 9, 2016
- Kaketsuken in Talks to Transfer Vaccine Biz to Astellas
April 8, 2016
- Kaketsuken Ordered Record 110-Day Suspension, Shiozaki Says He Won’t Allow It to Remain As-Is
January 12, 2016
- Kaketsuken Faces 110-Day Biz Suspension, Urged to Dissolve as Legal Entity
January 8, 2016
- MHLW to Establish Task Force in Response to Scandal at Kaketsuken
December 16, 2015
- JPMA Sets to Respond Harshly to Kaketsuken Cover-Up: Chief
December 8, 2015
- MHLW Panel Approves Additional Shipment of Kaketsuken’s Venilon, Novact
November 20, 2015
- PAFSC Committee Approves Resumed Shipments of Kaketsuken’s Venilon due to Potential Shortage of Substitutes
October 2, 2015
- Kaketsuken Reports Results of Internal Probe on Improper Blood Product Manufacturing
September 11, 2015
- Kaketsuken Withdraws Earlier Explanation of Blood Products Scandal; Problem Discovered through Information Provided to MHLW
July 23, 2015
- MHLW Panel OKs Shipment of 2 Kaketsuken Blood Products
July 22, 2015
- Kaketsuken Likely to Face Administrative Penalty over GMP Violation
June 24, 2015
- Kaketsuken Suspends Shipments of 12 Products Due to Modifications of Approved Manufacturing Procedures
June 9, 2015
REGULATORY
- Novartis’ Radioligand Therapy, Other New Meds Up for Japan Panel Review on Aug. 22
August 12, 2025
- Japan Nears Approval for 1st Biosimilars of Actemra, Simponi, and Ranmark
August 12, 2025
- Japan Approves FY2026 Budget Guidelines, Natural Increase at 400 Billion Yen
August 12, 2025
- PMDA Flags New Potential Risks for RAS Agents and Others
August 12, 2025
- Japan Approves MSD’s 21-Valent Pneumococcal Vaccine
August 8, 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…