Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
COMMENTARY
With Only 5 Months Until Nitrosamine Self-Inspection Deadline, Many Challenges Remain
Only five months remain until the final deadline for large-scale self-inspections of nitrosamine impurities in pharmaceuticals that have been requested by the Ministry of Health, Labor and Welfare (MHLW). The recently released results of an MHLW survey reveal that drug…
To read the full story
Related Article
- MHLW to Issue Guidance for Setting Acceptable Limit for Nitrosamines This Fall
August 6, 2024
- Nitrosamine Self-Inspection Deadline Extended to Aug. 1 amid Challenges
August 1, 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
COMMENTARY
- Japan’s Redefinition of “High-Priority” Vaccines Likely to Speed Up Discussions on NIP Access
January 27, 2025
- Japan Expects to Approve/List 43 Novel Drugs in 2025 Including Ultra-Expensive Gene Therapies
January 9, 2025
- Where Do Japan Drug Makers Stand? A Comparison with Other Industries and Mega Pharma Peers
December 24, 2024
- Battle over Off-Year Price Revision Now Heading for Political Settlement
December 13, 2024
- Drug Price Gap Hits Record Low, Did Distribution Guidelines Play Any Role?
December 10, 2024
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…