Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
REGULATORY
MHLW Panel Sets Topics for PMD Act Amendment; Pediatrics, Drug Loss on Agenda
A key Japanese health ministry panel on April 18 agreed on four themes to be discussed towards an envisaged amendment of the Pharmaceuticals and Medical Devices (PMD) Act, which is slated to come up for Diet deliberations as early as…
To read the full story
Related Article
- Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
December 27, 2024
- Japan to Require Drug Makers to Set Up Legal Post of “Stable Supply Manager”
November 29, 2024
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- MHLW Lays Out Updated Discussion Timeline for PMD Act Amendment
September 13, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
January 31, 2025
- MHLW to Take Balanced Approach in Dealing with Off-Year Revisions: Minister
January 31, 2025
- MHLW Orders Label Revisions for Lixiana, Keytruda, and More Drugs
January 30, 2025
- Pfizer’s Litfulo Braced for Price Cut after Cost-Effectiveness Assessment
January 30, 2025
- MHLW Panel Finalizes NIP Inclusion of Shingles Jabs, OKs New Basic Immunization Plan
January 30, 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…