Generic drug makers are hailing the planned creation of a new government fund designed to support the industry’s manufacturing infrastructure,…
REGULATORY
Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS
A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the use of central institutional review boards (IRBs) in a bid to boost the efficiency of clinical trials in Japan. The…
To read the full story
Related Article
- MHLW Sets Exceptions to All-Case PMS through Revised Q&A
July 22, 2024
- Regulation Panel’s Final Report Specifies Exemptions for All-Case PMS
April 25, 2024
- Pharma Regulation Panel Wraps Up Debate, Report to Be Finalized Soon
March 22, 2024
- Pharma Regulation Panel to Explore Potential Criteria for All-Case PMS Requirement
January 15, 2024
REGULATORY
- Shionogi’s ADHD Game Therapy, CureApp’s Alcoholism App in Line for Approval
February 7, 2025
- Drug Ecosystem Budget Project Is for Private Sector: Minister
February 7, 2025
- Japan’s 1st Hemophilia B Gene Therapy Up for Panel Review on Feb. 19
February 6, 2025
- PMD Act Set for Amendments Covering Issues Unaddressed over Past Decade: MHLW Official
February 4, 2025
- Council OKs Public Knowledge Application for CellCept Label Expansion
February 3, 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…