Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…
REGULATORY
Pharmaceutical Affairs Council Approves Basic Plan for “Humanitarian Trials”
The Ministry of Health, Labor and Welfare (MHLW) has compiled a basic plan for the implementation of “humanitarian trials,” a Japanese version of the compassionate use system. The plan would permit expanded access to new drugs following domestic “main studies,”…
To read the full story
Related Article
- MHLW Council on Unapproved Drugs to Review Appropriateness of Humanitarian Trials, Notification Due Out November
October 15, 2015
- Humanitarian Trial Data Will Be Supplementary Reference to Confirmatory Studies: Govt
October 5, 2015
- “Humanitarian Trials” Not Welcomed but Well-Designed: JPMA Regulatory Chief
September 30, 2015
REGULATORY
- MHLW’s FY2025 Budget Includes 7.7 Billion Yen to Drive Drug Commercialization
January 6, 2025
- Japan Approves Zepbound, Qalsody, and Lots More Drugs
December 27, 2024
- Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
December 27, 2024
- LDP Members Urge Ministers to End “Mechanical” Off-Year Price Cuts
December 27, 2024
- Japan to Set Up Fund to Spur Generic Shakeup; CEA, Market Expansion Re-Pricing on Agenda
December 26, 2024
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…
Takeda Pharmaceutical’s overseas sales ratio has reached 90.9%, exceeding 90% for the first time though only in the first half…
In a recent conversation with James Feliciano, former president of AbbVie Japan, we delved into the intricacies of leadership in the Japanese pharmaceutical industry. Feliciano, a seasoned industry veteran, shared valuable insights into his experiences, challenges, and successes.Navigating the Abbott…
A Japanese health ministry panel on November 28 agreed on a plan to legally require pharma companies to set up…
Eli Lilly’s Kisunla (donanemab) will join the Japanese reimbursement list on November 20, with a health ministry panel giving 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…