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
Kobayashi Kako Slapped with Record 116-Day Business Suspension
The Fukui prefectural government on February 9 ordered a record-long business suspension of 116 days to Kobayashi Kako over a sleep-inducer contamination found in its antifungal drug itraconazole, which has caused a slew of serious health damages including deaths. The…
To read the full story
Related Article
- Kobayashi Kako to Withdraw Marketing License on April 1
March 23, 2023
- Kobayashi Kako to Withdraw Marketing License Next April
June 28, 2022
- Kobayashi Kako Submits Biz Improvement Plan Over Fudged Drug Filings
May 31, 2021
- Biz Improvement Order Issued to 3 Codevelopers over Kobayashi Kako’s Fudged Data
May 24, 2021
- MHLW Revokes Approval for 12 Kobayashi Kako Products, Imposes Biz Improvement Order
April 30, 2021
- Kobayashi Kako Starts Recalling Products Subject to Approval Revocation
April 22, 2021
- Kobayashi Kako Chief Sorry for Fake Application Documents; Third-Party Report Reveals New Problems
April 19, 2021
- MHLW to Revoke Approval of 12 Kobayashi Kako Products as Documents Fabricated
April 19, 2021
- Kobayashi Kako’s Seima Factory Operations Still Halted Even after 60-Day Order Lifted
April 12, 2021
- Kobayashi Kako to Invite Outsider to Take Over Top Post: Biz Improvement Plan
March 11, 2021
- Meiji to Discontinue Sale of Kobayashi Kako Products after Biz Suspension
February 26, 2021
- 4 APIs/9 Products Excluded from Kobayashi Kako Biz Suspension for Medical Needs
February 24, 2021
- Kobayashi Kako Chief to Resign over Drug Mix-Up, Lousy Manufacturing and Cover-Ups
February 10, 2021
- Kobayashi Kako Expelled from JGA over Drug Mix-Up
February 10, 2021
- Regulators to Issue Biz Suspension Order to Kobayashi Kako on Feb. 9
February 8, 2021
- Kobayashi Kako Might Face 116-Day Biz Suspension over Drug Mix-Up
January 27, 2021
- Kobayashi Kako Notified of Record Biz Suspension of 110-Plus Days over Drug Mix-Up
January 26, 2021
- Kobayashi Kako Submits Report on Drug Mix-Up, Could Face Administrative Penalty in 1st Half of February
January 21, 2021
- Kobayashi Kako Expected to Face Administrative Penalty This Fiscal Year, Biz Suspension Likely
January 12, 2021
- First Time FPMAJ’s Supply Coordination Scheme Invoked for 13 APIs Tied to Kobayashi Kako
January 5, 2021
- Kobayashi Kako Adds 2 APIs to Class II Recall List, Meiji/Elmed Products
December 28, 2020
- Kobayashi Kako Recalls 12 More APIs after On-Site Inspections
December 25, 2020
- Results of On-Site Probe into Kobayashi Kako Due Out Early Next Year, MHLW Eyes Biz Suspension
December 24, 2020
- 2nd Death Reported for Tainted Itraconazole User, Doctor Says Causal Link Unlikely
December 18, 2020
- Kobayashi Kako Manually Managed Itraconazole Production; Hand-Written Record on Rilmazafone Mix-Up Found
December 17, 2020
- Kobayashi Kako Temporary Halts Shipments of All Products after Tainted Itraconazole Issue
December 15, 2020
- 1st Death Reported for Kobayashi Kako’s Tainted Itraconazole Product
December 14, 2020
- Kobayashi Kako Recalls Trigger Shipment Control for Kaken's Itraconazole Product
December 11, 2020
- Pharmacist Group Chief Appalled at Itraconazole Recalls; 84 Cases of Health Damages Reported
December 10, 2020
- With Contaminated Itraconazole, Patients Might Have Taken Sleep Inducer at 10-20 Times Regular Dosage
December 9, 2020
- Kobayashi Kako Launches Another Recall for Itraconazole, Class II This Time
December 8, 2020
- Kobayashi Kako Recalls Itraconazole over Hypnotic Contamination; Side Effects Confirmed
December 7, 2020
REGULATORY
- Japan Approves MSD’s 21-Valent Pneumococcal Vaccine
August 8, 2025
- Public-Private Council WG to Focus on Innovation Evaluation for FY2026 Reform: Official
August 8, 2025
- Chuikyo Approves Insurance Coverage for 4 In Vitro Diagnostics
August 8, 2025
- Japan to Discuss Negative Margins, Packaging Optimization towards FY2026 Reform
August 8, 2025
- Medical Device Pricing Body Urges Clearer Evaluation Criteria for SaMDs Reimbursement
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…