Japan plans to revise its definition of “vaccines of high development priority.” The Ministry of Health, Labor and Welfare’s (MHLW)…
REGULATORY
Lower House Clears Bill to Amend Next-Gen Medical Infrastructure Law
Japan’s Lower House approved a draft bill to amend the next-generation medical infrastructure law on April 13, which would create a new category of data called “pseudonymized medical information” with a view to its use in regulatory submissions. The bill…
To read the full story
Related Article
- Japan’s Amended Next-Gen Medical Infrastructure Law Takes Effect
April 2, 2024
- Japan Diet Ends Ordinary Session, All 7 MHLW-Submitted Bills Enacted
June 22, 2023
- MHLW Planning to Submit 6 Bills in Ordinary Diet Session, “Japan CDC” Plan Included
January 13, 2023
- “Pseudonymized Medical Info” to Be Created to Fuel Healthcare Data Use in Filing
January 5, 2023
- Working Group Urges Govt to Discuss Use of Anonymized Medical Data for Regulatory Purposes
June 2, 2022
REGULATORY
- 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
- LDP OKs Govt’s 5-Year Healthcare Strategy with “Expanding Ecosystems” as Main Pillar
February 3, 2025
- Lixiana Now Set for Label Expansion; 11 Drugs to Get Orphan Tags
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…