In late January, a bill to amend the Pharmaceuticals and Medical Devices Act cleared key legislation review processes by the…
REGULATORY
MHLW to Issue Guidance for Setting Acceptable Limit for Nitrosamines This Fall
Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to issue a guidance this autumn regarding measures to manage the risk of nitrosamine impurities in pharmaceuticals. Referring to guidance from its European and US counterparts, the regulator is expected to…
To read the full story
Related Article
- MHLW Issues Guidance to Thwart Distribution of Drugs with Unacceptable Nitrosamine Levels
January 10, 2025
- Nitrosamine Self-Inspection Deadline Extended to Aug. 1 amid Challenges
August 1, 2024
- With Only 5 Months Until Nitrosamine Self-Inspection Deadline, Many Challenges Remain
June 7, 2024
- Carcinogen Self-Inspection Survey Suggest 10% of Products at Risk: MHLW
April 22, 2024
- Pharma Industry Frets Cost and Deadline of MHLW-Ordered Carcinogen Risk Inspections
February 7, 2022
- MHLW Orders Large-Scale Carcinogen Risk Inspections, Covering Almost All Drugs
October 11, 2021
REGULATORY
- MHLW Not Yet Able to Examine Letters of Protest by US Lobbies: Minister
February 13, 2025
- More Flu Drugs Returned than Supplied in Japan: Final Week of January
February 12, 2025
- PMDA to Modify Onsite GCP Inspections Based on Facility Track Records
February 10, 2025
- PMDA Reviewing Safety Risks for Immune Checkpoint Inhibitors, CAR-Ts
February 10, 2025
- Shionogi’s ADHD Game Therapy, CureApp’s Alcoholism App in Line for Approval
February 7, 2025
As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…
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…
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…
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…